IN THE NEWS
The Antibody Test That Quantifies COVID-19 Vaccine Protection
By: Dr Stephen Russell, MD, PhD, Imanis Life Sciences
Click here to read the Technology Networks article
As vaccines continue to be rolled out across the country, it is important for the public to understand that herd immunity cannot be validated by inoculation rates alone. Health officials and providers must now consider how strong neutralizing antibody levels (titers) will be for vaccinated individuals over time.
While two of the authorized vaccines are more than 90% effective, immunity to the virus after vaccination will inevitably wane, raising important questions:
- How long will vaccines provide protective immunity?
- Are vaccines working as expected in each person?
- Which vaccines appear to be creating the strongest titers, and which have the weakest (the higher the titer, the better the body’s ability to protect against infection)?
- What titer ensures safety from exposure to COVID-19?
- When should a booster be administered?
To help address these critical questions, hospitals, clinics, and private practices now have access to new neutralization assays for individuals which can improve informed decisions about vaccine deployment and better ensure the safety of the population at large.
The key determinant of protection
Neutralizing antibodies are the key determinants of protection from future infection and, for the first time, well-validated high-throughput virus-based assays for COVID-19 can accurately quantify the titers of neutralizing antibodies in individuals. The neutralization assay is a simple blood test, so it is relatively quick and easy to administer, but it provides highly specific information that can help determine future safety protocols and provide clarity about next steps for healthcare providers and vaccinated individuals. Such monitoring can be used to better understand what levels of neutralizing antibodies are required for protection and help establish booster dosing schedules needed to sustain vaccine-induced immunity.
With the ability to regularly measure neutralizing antibody titers in vaccinated individuals, we can understand how risk levels can change over time. For example, a titer of 500 (where the antibody is still detectable even when the blood is diluted 500-fold) provides sufficient antibody protection, but a titer of 100 may not provide sufficient protection if you are planning to get on an airplane. For the greater society, detailed, up-to-the-minute data on immunity levels can guide the next phase of recovery – evidence-based analyses of protection that will help public health officials and the entire healthcare community develop vaccine strategies designed to control the future trajectory of the pandemic.
Measuring the durability of immunity
To develop these new types of assays, researchers have been modeling the relationship between in vitro neutralization levels and observed protection from infection using data from seven current vaccines, as well as convalescent cohorts.
A recent study analyzing immunity levels to COVID-19 leveraged data from early antibody tests and indicates titers decline at least 50% (and up to 80%) within six months of recovery from COVID-19. Within the first 250 days after immunization, models for the decay of neutralization titers also predict a significant loss in protection from COVID-19 infection. In fact, the decay of neutralization titers in vaccinated subjects over the first three-to-four months post-vaccination is at least as rapid as the decline observed in convalescent subjects. This intel also enables researchers to see how waning immunity and antigenic variation might affect vaccine efficacy.
Overall, the study proves that neutralizing antibody titers drop rapidly after natural infection. Individuals develop a wide range of neutralizing antibody titers, despite the severity of their illness. Given significant variables surrounding each individual, periodic quantitative testing can help lead to a better understanding of the decline in neutralizing antibody titers in both recovered patients and those who have been inoculated.
By monitoring neutralizing antibody levels over time, we can also be more confident in determining optimal vaccine dosing strategies, improving vaccines and immunotherapies, and reopening economies and social interactions.
Validating test accuracy
To validate the accuracy of these new assays, comparisons have been made to the plaque reduction neutralization test (PRNT), which measures virus-specific neutralizing antibody titers and remains the gold standard for serological testing and the determination of immune protection. Based on this comparison, the neutralization assay’s titers correlate strongly with titers resulted from PRNT. However, unlike the PRNT, neutralization assays offer a widely scalable surveillance of COVID-19 protection and vaccine efficacy to meet the enormous global demand.
A recent in-depth report published by medRxiv demonstrates the feasibility and utility of IMMUNO-COV™ v2.0, a neutralization assay for measuring SARS-CoV-2 neutralizing antibodies in vaccinated individuals and individuals recovering from natural infections. With high-quality monitoring, we can better understand what levels of antibodies are required for protection and what booster dosing schedules are needed to sustain vaccine-induced immunity.
It is needless to say that our world felt turned upside down when the pandemic struck. However, with the rollout of vaccines, we are finding a way out of this tragedy and back on top. With neutralization tests, we can provide targeted data and insights about how to proceed and plan confidently in the days and months ahead as the first round of vaccinations are completed.
In short, we will have the information we need to make informed decisions about ensuring the safety of our nation, and the world.
How a 7th Grade Science Project Set a Little Girl on the Path to Become a Leading COVID-19 Antibody Researcher
By: Allie Weintraub
Click here to read the Inside Edition article
Dr. Rianna Vandergaast’s path as a lead researcher in COVID-19 neutralizing antibody testing began with a simple, seventh grade science project. Her father, an environmental scientist, was the one who suggested they collect water samples from people in their own neighborhood.
“We actually went around to our neighbors, because we lived out in the country at that point,” Vandergaast told Inside Edition Digital. “And so most people had their own wells rather than being on city water. And we would collect samples and we just kind of randomly knocked on people’s doors and explained that I was doing this project, and would they let us go take a sample from their well?”
The Minnesota-based scientist said that the moment was pivotal for her, because she realized that science was exciting not only as a vehicle to learn new things, but also for its ability to solve real-world problems.
After earning her PhD in biochemistry at University of Wisconsin-Madison, Vandergaast ended up as a principal scientist at biotech company Imanis Life Sciences. When the COVID-19 pandemic began last year, the company already had a group specializing in making oncolytic viruses, which are engineered to target and kill cancerous tumors.
“I remember, I went home Friday, not really having anything on my radar about this, to suddenly, then Sunday morning, there being an emergency meeting called,” Vandergaast said.
By March, it was “all hands on deck” to develop an assay for detecting neutralizing antibodies indicative of a COVID-19 immune response.
The Plaque Reduction Neutralization Test (PRNT) is considered the “gold standard” for serological testing, although it is not widely scalable for surveillance of COVID-19 protection and vaccine efficacy, according to Imanis.
It also uses the actual virus, which requires working at a “biosafety level three,” Vandergaast said. “There’s a lot of specialty things that are needed in those labs. And there’s just not — you don’t find biosafety level three labs everywhere. So right away that limits the number of labs that are able to do it.”
By contrast, the assay developed for Imanis’s test, IMMUNO-COV, doesn’t use the actual virus, and Vandergaast’s lab works in biosafety level two.
“What we did with this test is we took this harmless virus and we gave it the spike protein from SARS-CoV. That’s the part of the coronavirus that it uses to get into a cell.”
Researchers tracked which cells were getting infected by the virus with luciferase — the protein in a firefly that makes it glow.
“We don’t have to look at everything by eye. We have machines that are able to go in and very, very quickly in less than a second read and see, is there are a lot, or is there a little bit of infection in this well? So we set it up in such a way that not only can we work at a safer level, but we can handle a much larger quantity of samples because we’ve got these machines that can read them very, very quickly,” Vandergaast said.
The test not only tells you if you have the neutralizing antibodies, but also how much of them that you have, which is an important indicator for researching long-term COVID-19 immunity.
In a study conducted by Imanis Life Sciences in collaboration with Vyriad, Mayo Clinic, Regeneron Pharmaceuticals and the World Reference Center for Emerging Viruses and Arboviruses, researchers found that individuals infected with COVID-19 experienced, on average, at least a 50% decline in the amount of neutralizing antibodies within six months.
The study, which was co-authored by Vandergaast and Stephen J. Russell, also showed that although it’s a trend, a case of severe COVID-19 does not always result in higher levels of antibody protection than a case with mild or moderate symptoms. The participant with the highest titer level had moderate symptoms.
But the main focus with this particular study was developing the assay, so they were looking at a small number of samples, Vandergaast added.
“We think we have a pretty good initial sort of indication, but we really need to do studies with larger sample groups. And the power is that now that we have these IMMUNO-COV tests, we can go and do those studies,” Vandergaast said.
Vandergaast, a mom of two young boys, said she’s excited that her sons are starting to become more interested in science.
“One of my favorite days was when my older son, my 7-year-old, went to school and one of his friends got one of the COVID tests for looking for the virus — the one that goes down your nose. And he was relating to the other kids in his class how unpleasant it was to have that thing stuck down his nose. And my older son came home and he said, ‘I told him that your test isn’t so bad. You don’t have to stick anything down your nose,’” Vandergaast said.
What to do it you test positive for COVID-19 today
By: Amanda Capritto
Click here to read the CNET article
“If you test positive for COVID-19, or if you’re a parent and your child tests positive, it’s going to be a stressful day,” says Robin Coleman, co-founder of Contakt World and editor at Johns Hopkins University Press. “That means it’s a good idea to think [about what to do] ahead of time so that when the time comes, you already know how to start.”
Coleman makes a good point. No matter how cautious you are, there’s a chance you could catch COVID-19 — and it’s important to be prepared for that. With the help of several COVID-19 experts, CNET put together this timeline to help you navigate a coronavirus diagnosis.
Step 1: Get home or stay home
First of all: As soon as you receive word that you tested positive for COVID-19, go home (assuming you weren’t in a position to already be at home waiting for the results of the test). If you’re at work or in another public place, continue to take precautions such as wearing a mask and gloves and distancing yourself from others. Try to get home without stopping anywhere else.
If you live with other people, whether your family, a partner or roommates, encourage them to stay home as well. The current Centers for Disease Control and Prevention guidelines for isolation for those who are sick with COVID-19 include:
- Isolate until at least 10 days from the point at which symptoms appeared (or 14 days from a positive test if you haven’t noticed symptoms); and
- Until at least 24 hours have passed with no fever, without the use of fever-reducing medication; and
- Other symptoms of COVID-19, such as loss of taste, are improving.
For people who have known or suspected contact with someone who is sick from COVID-19, the CDC still recommends a 14-day quarantine. However, the CDC acknowledges that some local health agencies have endorsed shorter quarantine options, including 10 days without symptoms, or seven days with a negative test.
Step 2: Check your kids out of school
When someone in a family tests positive for COVID-19, unvaccinated family members must quarantine since they have had direct exposure. This includes children.
“School districts across the country have policies in place for this exact scenario,” says Dr. Michael Huang, national medical director for Marathon Health. If your child is attending in-person school, call the school and speak with the administration about arranging a safe way to get your child home from school, as well as getting any items they may need to complete schoolwork from home.
“This can be as simple as a friend picking up and dropping the items off to your front porch to ensure that no one is exposed in the exchange,” Huang says.
If you’re unable to arrange pickup and drop-off for your children and their items, ask the school administration if someone can escort your child to an outdoor pickup location where you can go and pick up your child without getting out of your car.
Step 3: Start notifying people
As soon as you’ve got your diagnosis, jot down the names of any people you’ve spent time with recently, Coleman says. “The more time you’ve spent with someone, the closer the proximity and the fewer safeguards were in place, the higher up the list they should go.”
He explains, “Think about it like this: If you’ve breathed the same air as someone for more than a few minutes, you want to have their name and contact info ready for when a contact tracer calls, which would ideally be within a day of your diagnosis.”
If you’re contacted by a tracer, they will also contact everyone you have on your list. However, sometimes contact tracers have limited capacity and may not get in touch with you on the day of your diagnosis. For this reason, it’s important to directly notify anyone you’ve been in contact with recently.
Use these categories to help you think about who to notify: home, work, school, recreation. “The people you spend the most time with will be at most risk and it will be really important for them to get tested and quarantine away from anyone else in their household,” Coleman says. “There’s no reason to be shy about letting people know that you’ve got COVID-19. It will give them the chance to keep their loved ones safer.”
Step 4: Line up help for potential caretaking scenarios
While you’re moving through your contact tracing list, ask trusted friends and family members if they’re available and willing to help should the need arise. This particularly applies to single parents or caretakers. If you fall very ill, who will take care of the people currently under your care?
“Unfortunately, there aren’t any easy answers here,” says Dr. Chad Sanborn, pediatric infectious disease specialist at KIDZ Medical Services. “While thankfully this isn’t a common scenario, it certainly can and does happen. I would have some sort of plan for this possibility, particularly if one or both parents work in a high-risk profession or have risk factors for becoming very ill from COVID-19.”
In general, it’s best to keep older adults away from COVID-19, so Grandma and Grandpa shouldn’t be your first call if you can avoid it, Sanborn says. If you have siblings, good friends, in-laws or even colleagues willing to help, ask them first.
Sanborn reminds parents and caretakers to tend to themselves, too: “While it’s natural to think of one’s child before one’s self, you have to remember to drink fluids, try to rest and seek medical attention if you’re really not feeling well,” he says. “You won’t help out your family much if you don’t care for yourself and end up really sick.”
Step 5: Explain the scenario to your kids
Telling your children you have COVID-19 may feel overwhelming, especially if your little ones have expressed fear about the virus in the past.
“For the smallest children, possibly not bringing up the term ‘COVID’ at all and referring to the illness as a cold may be best,” Sanborn says. “I wouldn’t lie if asked directly if you have an infection with COVID-19, but sometimes younger children may be very frightened by this disease.”
Also, don’t forget that your kids can pick up on your anxiety or fear, Sanborn says. “Show the small ones you can eat, drink, talk, smile and laugh despite being sick, even if only briefly,” he encourages. “Talk a little about what you are experiencing with them so as to demystify it.”
For older children, especially those who may be more familiar with masks and social distancing, it’s probably best to talk about the situation honestly and make them feel comfortable asking questions, Sanborn says. Make sure your children understand that the better everyone adheres to stay-at-home guidelines, the faster the household will return to normal.
Step 6: Take inventory of your home
After you test positive for COVID-19, expect to stay at home for a while. Take stock of kitchen and bathroom essentials, as well as any other necessities.
Jot down everything you might need in the next two weeks, for yourself and any family members or housemates who will also be staying home.
You may find it helpful to think in categories: food, fluids, medication, toiletries, paper products like napkins and toilet paper, cleaning items and comfort items.
Step 7: Order necessities via delivery
If this option is available to you, the best way to get what you need is via contactless delivery, whether you use an app or have a friend drop items off.
Step 8: Take care of yourself with at-home symptom management
Mild cases of COVID-19 can be treated at home with rest, fluids and over-the-counter cold and fever-reducing medications, says Huang.
It’s important to eat nutritious foods, too, even if you don’t have an appetite. Blending fruits and veggies into smoothies can help you get the calories you need if you don’t feel like eating. Add protein powder for more calories and for satiety.
Step 9: If symptoms worsen, seek medical care
Testing positive for COVID-19 by itself doesn’t mean you will need to go to the hospital, Huang says, but it’s always a good idea to touch base with your health care provider by phone after your diagnosis.
Most people are able to treat their COVID-19 symptoms at home, but if you experience severe or sudden symptoms, including trouble breathing, persistent pain or pressure in the chest, new confusion or altered mental status, inability to wake up or stay awake, weakness or bluish discoloration lips or face, seek immediate medical attention, Huang urges.
If you do seek medical care, be aware of your treatment options and ask your doctor to thoroughly explain anything you don’t understand. According to Brian Foster, CEO of BioIncept, a pharmaceutical development company, common therapies for hospitalized COVID-19 patients include supplemental oxygen with high-flow oxygen, noninvasive ventilation or mechanical ventilation; dexamethasone (a glucocorticoid or steroid); and remdesivir (an antiviral agent).
Step 10: Navigate the emotions
Finally, getting a COVID-19 diagnosis can bring about many big and unpleasant emotions. Alyza Berman, licensed clinical social worker and founder of The Berman Center, says anyone who tests positive for COVID-19 should be prepared for what feels like the stages of grief:
- Shock and denial
- Pain and guilt
- Shame and depression
It can be challenging to do everything you need to do while navigating those big emotions, Berman says. But it’s important to take your diagnosis seriously and follow public health guidelines, she emphasizes.
“While part of the battle is beating COVID physically, the other half is all about keeping mentally strong and your mental health in check,” Berman says. Keeping yourself mentally stimulated while in isolation, talking to people on the phone, expressing your feelings about the diagnosis, and taking care of your physical health to the best of your ability will help, she says.
Should you get vaccinated if you’ve had COVID-19?
Most health experts recommend that people still get vaccinated even if they’ve already contracted COVID-19 in the past because “the protective neutralizing antibodies that your body produces because of infection do not last forever,” says Dr. Stephen Russell, M.D., Ph.D., CEO and co-founder of Imanis Life Sciences.
“Neutralizing antibody titers are typically lower in people who have recovered from a mild infection and higher in people who had a more severe infection, but either way, they fall after the infection is over.”
If antibody levels have fallen to a very low level, there is risk of reinfection, Russell says. “A vaccine dose administered three months after you have recovered from COVID-19 will boost the protective antibody levels, resulting in a much longer period of protection from reinfection than would otherwise be the case.”
Published March 10, 2021: https://www.cnet.com/health/what-to-do-if-you-test-positive-for-covid-19-today/
Can Non-Vaccinated People Get Vaccinated People Sick With COVID-19?
By: Kayla Hui, MPH
Click here to read the Verywell Health article
- Non-vaccinated people can still get vaccinated people sick with COVID-19.
- Vaccinated people who contract COVID-19 may have less severe symptoms because the body mounts an immune response and adapts to prevent the coronavirus from replicating.
- More research is needed about how the COVID-19 vaccines respond to emerging variants.
On March 8, 2021, the Centers for Disease Control and Prevention (CDC) released guidelines stating that fully vaccinated people—two weeks or more after receiving the second dose of Pfizer or Moderna vaccines or a single dose of Johnson & Johnson—may visit unvaccinated people from a single household who are at low risk for severe COVID-19.
While the high rates of protection offered by the three authorized vaccines have been widely praised, they’re not 100%. Verywell asked experts to weigh in on whether non-vaccinated people can still get vaccinated people sick with COVID-19.
The Risk Is Low, but Not Zero
According to Stephen Russell, MD, PhD, president of the American Society of Gene and Cell Therapy, despite the vaccines’ high efficacy rates at protecting people from contracting COVID-19, they do not offer 100% protection.
When it comes to preventing disease, the efficacy rates for the vaccines are:
- Pfizer: 95%
- Moderna: 94%
- Johnson and Johnson: 66%
The vaccines have a near 100% efficacy rate for preventing serious illness, hospitalization, and death.
“There is no vaccine that is currently 100% effective, which means while the risk of a vaccinated person contracting the virus is much lower, there is still no guarantee they are fully protected,” Russell says.
Vaccinated individuals can still contract COVID-19 from unvaccinated people, according to Christine Bishara, MD, internal medicine physician practicing in New York City. She says that there is still a chance that vaccinated people can develop symptoms, although the likelihood is much lower.
“This is because vaccination allows the body to mount an immune response so that if infected, the body recognizes the virus and immediately initiates an adequate immune response that prevents the virus from replicating,” Bishara tells Verywell. Bishara says that the current vaccines allow the body to build antibodies against spike proteins–the protein that causes COVID-19–until they have been destroyed.
*What This Means For You
If you have been fully vaccinated, it is still best to continue to follow CDC’s safety guidelines like wearing a mask and social distancing in public. However, your risk of contracting COVID-19 from an unvaccinated person is low, and even if you do contract a variant of the virus, your body may still be able to develop an immune response against it.
Developing an Immune Response against Variants
Although there is a lower risk of severe COVID-19 symptoms among vaccinated people, there is still a public health risk, especially for COVID-19 variants. “Without the protective antibodies from vaccination, unvaccinated persons would be at particular risk from contracting COVID since many of these new strains have a higher rate of transmission as they adapt to the human respiratory tract,” Sanjiv Shah, MD, chief medical officer for MetroPlusHealth in New York City, tells Verywell.
As new variants emerge, Bishara says that the good news is that vaccinated people will still be able to produce an immune response, despite showing symptoms. “While new variants may cause some symptoms, the vaccinated individual is still able to mount an adequate response preventing severe protection,” Bishara says. That’s because when the body builds antibodies against the coronavirus, Bishara explains that memory T-cells are equipped to recognize the virus and formulate a protective response.
T-cells are another component of the immune system. While most COVID-19 immune research has looked at antibodies, a new research study (not yet peer-reviewed) led by Alessandro Sette and Shane Crotty from the La Jolla Institute of Immunology found that T-cell response held up when T-cells were exposed to COVID-19 variants.
“We do not know how long this protection may last and it may be partly related to the degree of mutations,” Bishara says. Because the length of protection from the Pfizer and Moderna vaccines are unknown, Pfizer and Moderna are considering adding a third booster shot that would account for protection against other variants.
Keep Following Guidelines
Russell says that although the risk of a vaccinated person contracting the virus from an unvaccinated person is much lower, all individuals should still practice safety guidelines as outlined by the CDC. “While the vaccine confers a certain level of protection to the virus, continuing to follow the guidelines are the best practice,” Russell says.
The CDC states that fully vaccinated people can:
- Visit with other fully vaccinated people indoors without wearing masks or physical distancing
- Visit with unvaccinated people from a single household who are at low risk for severe COVID-19 disease indoors without wearing masks or physical distancing
- Refrain from quarantine and testing following a known exposure if asymptomatic
According to Shah, the best way to stop new variants from forming and spreading is to have as many people vaccinated as quickly as possible. “The approved vaccines appear to work well against the strains of COVID,” Shah explains. “We are in a race to build a high enough barrier through vaccination before the virus can create a new, worse spike.”
Published March 10, 2021: https://www.verywellhealth.com/covid-19-transmission-vaccination-5115630
Imanis Life Sciences Announces New Data from Clinical Assay Measuring SARS-CoV-2 Neutralizing Antibodies
- Clinical validation of high throughput assay that provides numeric results (titer) of neutralizing antibodies
- Former COVID-19 patients, in a small preliminary sample set, saw marked decline in neutralizing antibodies within six months
- Assay shows no guarantee that severe disease results in higher levels of antibody protection
ROCHESTER, Minn., Feb. 23, 2021 – Imanis Life Sciences (“Imanis” or “The Company”), in collaboration with Vyriad, Inc. and Regeneron, today announced data from its latest improved IMMUNO-COVTM test, an assay for the quantitative measure of SARS-CoV-2 (COVID-19) neutralizing antibodies. The manuscript is available on medRxiv and has been submitted for additional publication following scientific peer review.
Data acquired from a small initial cohort showed that neutralizing antibodies declined at least 50% within six months in nearly all individuals recovering from COVID-19 infection. Samples from this small test group were first secured in April and then again in October and tested via IMMUNO-COV, the first scalable, quantitative virus neutralizing antibody test for COVID-19. The results correlated closely with those acquired by plaque reduction neutralization test (PRNT), which remains the gold standard for serological testing and determining immune protection. A scalable, clinical test for measuring neutralizing antibody titers is critical for large population studies of COVID-19 immunity. Imanis, with its IMMUNO-COV assay, plans to test samples from larger cohorts to continue to track the rate of neutralizing antibody decline in both recovered patients and inoculated individuals.
“IMMUNO-COV was developed to address the unmet and urgent need of a deeper understanding around the spread of COVID-19,” said Michael Herbert, Chief Commercial Officer at Imanis. “PRNT is the gold standard of quantitative assays, which is why we ensured our results correlated; however, it is not widely scalable for surveillance of COVID-19 protection and vaccine efficacy. We are proud to be able to offer a solution to this gap through IMMUNO-COV, which is both accurate and widely scalable.”
As part of the clinical trial, participants were asked to report the severity of their COVID-19 symptoms in order to compare disease severity to the number of SARS-CoV-2 neutralizing antibodies detected by the assay. While the general trend supported the current notion that people with more severe cases of COVID-19 are more likely to generate higher levels of neutralizing antibodies, the assay showed there is no guarantee that severe disease results in higher levels of antibody protection. Regardless of disease severity, individuals develop a wide range of neutralizing antibody titers.
“Neutralizing antibodies are key determinants of protection from future infection,” said Rianna Vandergaast, Ph.D., Principal Scientist at Imanis. “The ability to monitor neutralizing antibody titers could not only help us determine the duration of immunity, but also better understand the timeline required between vaccine inoculation and boosters.”
“These results continue to support the value and validity of IMMUNO-COV,” said Stephen Russell, M.D., Ph.D., CEO and co-founder of Imanis. “We are encouraged by the continued possibilities of the test to help answer many of the burning questions around COVID-19.”
About Imanis Life Sciences
Imanis Life Sciences has an unwavering commitment to the advancement of science. For many companies, profitability rules decision making. But at Imanis, leading scientific breakthroughs is the primary focus. We are about making a difference in the world by putting people in a better position than they were yesterday. We strive to do this by being a leader in laboratory assays and research services to accelerate the development of a broad range of next-generation therapies. Imanis Life Sciences is located in Rochester, Minnesota. For more information, visit https://imanis-immunocov.com/.
Chief Commercial Officer
Imanis Life Sciences
FDA: New COVID-19 Variants May Cause False Negatives on Diagnostic Tests
By: Jocelyn Solis-Moreira
Click here to read the Verywell Health article
- The new coronavirus variant contains genetic mutations that may interfere with diagnostic testing.
- There is a small risk of diagnostic tests producing a false negative test result.
- Having a false negative result can cause people to unknowingly spread the virus.
On January 8, the Food and Drug Administration (FDA) warned of the potential for coronavirus tests to produce false negative results because of genetic variants of the SARS-CoV-2 virus. This announcement comes after a new COVID-19 strain called B.1.1.7 emerged in the United Kingdom, which has also been detected in the United States.
The strain has driven up concerns about the accuracy of polymerase chain reaction (PCR) tests, also called molecular tests, the current gold-standard in COVID-19 testing. That’s because PCR tests look at the virus’s genetic material, and the variant is causing that genetic material to look slightly different.
Stephen Russell, MD, PhD, CEO, and co-founder of Imanis Life Sciences explained to Verywell that PCR tests work by detecting different parts of the virus. “The virus is essentially a genome—a piece of genetic material that carries all the information needed to replicate itself—and a protein shell. So, the diagnostic test either locks on to the genome or it locks on to the protein shell.”
A PCR test looks at the genome.
“The genetic material inside the coronavirus has about 30,000 ‘bases,’ and PCR tests detect less than a hundred of them,” Russell says. “The U.K. variant is missing a little bit of sequence, and it’s lost two amino acids. This means six of those 30,000 bases in the viral genome are gone. And that’s where some of these PCR tests lock on to the virus. So, having the variant may turn a positive test to a negative test.”
Do COVID-19 Variants Make Diagnostic Tests Less Reliable?
Russell says different PCR tests rely on different bases to collect the virus’s genetic information, so diagnostic tests aren’t completely unreliable. The FDA expects SARS-CoV-2 to continue to mutate, and has authorized diagnostic tests that can target multiple genetic mutations. This lowers the chance of receiving a false negative.
“There’s always been a concern about the accuracy of the tests. There’s no test out there that doesn’t give you false negatives and that doesn’t give you false positives,” Russell says. He adds that swabbing technique, sample size, and how the sample is handled in the lab can create variability.
“I don’t think the new variants are making a real difference to [testing] reliability at this point,” he says.
Which Tests May Produce a False Negative?
The FDA states that three PCR-based COVID-19 diagnostic tests–which each have emergency use authorization—contain a small risk of producing a false negative.
- Accula SARS-Cov-2 Test
- TaqPath COVID-19 Combo Kit
- Linea COVID-19 Assay Kit
However, the FDA says that because TaqPath and Linea tests lock on to multiple genetic targets, the new variant shouldn’t hinder overall test sensitivity.
What This Means For You
If you believe you’ve been exposed to COVID-19, get tested. While the chances of getting a false negative are low, you should continue to act cautiously and quarantine for at least 14 days.
What Should People Do?
A major public health consequence of receiving a false negative is that people may unknowingly spread the virus to others if they think they’re COVID-free. “If you test negative, that does not mean you’re definitely negative,” Russell says. “If you have a high index of suspicion that you may still be positive, then don’t assume that test is the final answer.”
Still, he doesn’t suggest getting tested every week unless your job requires it or you pose a high risk to others. For now, Russell says the best thing is to get vaccinated once vaccines become available to you.
If people are still suspicious of infection even after vaccination or multiple negative tests, Russell says it might be worth taking an antibody test for peace of mind.
Published January 15, 2021: https://www.verywellhealth.com/fda-new-covid-19-variants-may-cause-false-negatives-on-diagnostic-tests-5095652
The 20 Hottest Digital Health Startups From Flyover Country, 2021
By: Arick Wierson and Beau Draghiciu
Click here for full list
The publication of last year’s list of the hottest companies in digital health in between the coasts—in so-called Flyover Country—now seems like it happened ten years ago. The coronavirus pandemic, which helped stretch 2020 into an interminable black hole, made it clear that healthcare innovation is a key to our survival as a species
And so as we now embark on the latest edition of our annual list of the hottest healthcare companies in Flyover Country, ahead of the JP Morgan Healthcare Conference (this year, not to anyone’s surprise, an entirely virtual event), we’re highlighting the ones our group of impaneled experts felt were doing exceptional work and creating extraordinary value in a healthcare milieu without modern precedent.
As in past years, we have assembled our kitchen cabinet of savvy health-tech venture capitalists, healthcare PE investors, coastal healthcare executives, and industry analysts to survey them about which companies they think are really killing it in the Midwest, Rockies and other places where every day is a good day for flannel or denim.
As in previous years, our list is not a ranking per se. All of the hundreds of companies considered for this year’s list are doing important work, helping to save lives, delivering better care, or creating a more efficient healthcare ecosystem. These are just the ones earning the most notice
- ImanisLife Sciences (Rochester, MN); Capital Raised: Undisclosed
Birthed from within the Mayo Clinic’s venture capital ecosystem, Imanis Life Sciences is a trailblazer in the field of non-invasive imaging research in regenerative medicine, gene therapy, oncology, and oncolytic virotherapy. Led by virology experts Stephen Russell MD, PhD and Kah Whye Peng PhD, Imanis Life Sciences advanced two new market ready, virus-based tools used in the fight against Covid-19. Imanis scientists, working along with colleagues from sister company Vyriad (also helmed by Russell and Peng), developed the Immuno-Cov V2.0 test, which measures a patient’s blood for the neutralizing antibodies that block SARS-Cov-2 infection, and a new Covid-19 vaccine candidate that has shown potential after tests in primates.
Published January 13, 2021: https://observer.com/2021/01/2021-20-hottest-digital-health-startups-flyover-country/
If You’ve Already Had COVID-19, Do You Need the Vaccine? Here’s What Experts Say
By: Claire Gillespie
Click here to read the Health article
As the long-awaited COVID-19 vaccine distribution process begins in the United States, there’s plenty of deliberation around who gets the vaccine, and when. Much attention has been brought to the people who have already been infected with COVID-19. Should they also get the vaccine? Don’t people who have had COVID-19 have immunity?
Stephen Russell, MD, PhD, CEO and co-founder of Imanis Life Sciences discusses what is known and what we’re still learning about immunity to COVID-19 with Health, and its implications to vaccine rollout.
Published December 17, 2020: https://www.health.com/condition/infectious-diseases/coronavirus/if-you-already-had-covid-do-you-need-vaccine
Antibody test puts Rochester at forefront of tracking COVID-19 immunity
By: Jeff Kiger
Click here for Post Bulletin article
How immune are you?
That’s the question developers of a new COVID-19 antibody test or assay hope to answer for patients and doctors.
Imanis Life Sciences, with the help of affiliate Vyriad, started working on its Immuno-Cov test in February, in collaboration with Regeneron and Mayo Clinic. Imanis and Vyriad, founded by Mayo Clinic researchers Dr. Stephen Russell and Dr. Kah-Whye Peng, share lab space in the Rochester Technology (former IBM) Campus.
While Imanis and Vyriad are focused on cancer treatment, they use viruses to combat it. That means viruses and vaccines are at the core of their collective knowledge.
“We were able to move pretty dang quickly, because this is in our wheelhouse. It was all hands on deck, and they built it in rapid time,” said Imanis Chief Commercial Officer Michael Herbert.
While the core test has been in use for a while, Imanis started processing patient samples in its growing labs on Monday, with a recently updated commercial, doctor-ordered version of the Immuno-Cov test. It costs $300.
Compared to standard COVID-19 antibody tests, this one provides much more precise information for patients and doctors to track immunity to the virus.
While all antibodies can identify the virus, only neutralizing antibodies can actually block the virus from entering cells to prevent infection. Immuno-Cov identifies and tallies the neutralizing antibodies in a measurement called a titer.
A follow-up test will then show how many neutralizing antibodies the patient still has weeks or months later. This will help track how immune a recovered COVID-19 patient is, as well as track the effectiveness of the coming vaccines.
It can also easily be adapted to track other SARS viruses that could follow COVID-19.
“When Steve (Russell) got everybody together in February, he told them that ‘Neutralizing antibodies are the thing,’ ” Herbert said.
Now the Imanis team, which has processed thousands of research samples to verify the test, is geared up to process more than 1,000 tests a day. That capacity will grow to an estimated 2,000 to 2,500, once the current 20,000-square-foot expansion of the Rochester labs is complete.
All of this means the Northwest Rochester biotech facility, which was already growing before the pandemic, is now booming.
“We’ve near tripled the number of Imanis/Vyriad employees in the past year to about 60. About 15 to 20 are dedicated to Immuno-Cov,” Herbert said, adding that the Immuno-Cov team will grow by about 10 more, no matter the volume of samples coming in.
Imanis is not the only company with an antibody test like this. But they are one of the first ones to hit the commercial market, with one by Siemens Healthineers also coming out this month.
Herbert said the team of Imanis, Vyriad, Regeneron and Mayo Clinic researchers led by Russell and Peng is enthusiastic about the expertise they can focus on this, while expanding here.
“We all agree that we want Rochester, Minn., to be on the map for understanding neutralizing antibodies and be the global standard of how to get that done in this pandemic,” he said. “The commitment to Rochester is not just lip service.”
New COVID-19 antibody test developed in Rochester
By: Samantha Boring
Click here for KAAL TV coverage
(ABC 6 News) — While many wait for news of a COVID-19 vaccine in the United States, a Rochester company says it has created something that can help figure out if you can fight the virus off on your own.
Imanis Life Sciences in Rochester has developed a new COVID-19 antibody test called IMMUNO-COV.
“This is a test that specifically looks for antibodies that are able to neutralize the SARS coronavirus 2 which is the virus that causes COVID,” Imanis Principal Scientist, Rianna Vandergaast said.
Imanis Life Sciences has been working on this test for months after releasing the first version at the beginning of the pandemic.
“It really gives you a better idea of what kind of level of protection you’re going to have against future infection,” Vandergaast said.
It is done through a blood test and Vandergaast says they look at something called the “Titer.”
“The titer is going to be how much of these neutralizing or protective antibodies do you have in a certain amount or volume,” Vandergaast said.
The science may seem complicated, but what it does is tells you if you have antibodies in your blood to protect you from COVID-19, If you do have the antibodies, this test will also tell you how many you have, which can determine how protected you may be.
“The higher your titer the more of these neutralizing antibodies you have and the better you are going to be protected from future infection,” said Vandergaaast. She says these antibody levels can drop quickly, and with news of a vaccine arriving at any moment in the U.S., Vandergaast says these tests can benefit us.
“Having a test like this where you can monitor and see is this something where I am still potentially susceptible to infection or not is going to be very important even as we start to get vaccines and have more of that herd immunity,” Vandergaast said.
She says tests like this will work hand-in-hand with the vaccine as scientists and researchers work to learn more about COVID-19 and stop it from spreading.
“I do think developing these kinds of neutralizing antibody tests and running them is just a critical part in understanding how efficient these vaccines are going to work, especially in the long term,” Vandergaast said.
Imanis says it has created enough material for 5 million tests. The tests became available to the public on December 3rd. They can only be ordered by a physician, and the cost is $300. To learn more about the IMMUNO-COV test click here.
Published December 9, 2020: https://www.kaaltv.com/coronavirus/rochester-mn-imanis-life-sciences-antibody-test/5946401/
Published December 7, 2020: https://imanis-immunocov.com/news/#1607371875538-69b4a6c3-cc5d
Dueling quantitative COVID-19 neutralizing antibody tests roll out as vaccines approach completion
By: Annette Boyle
Click here to read the BioWorld article
As COVID-19 vaccines ready themselves for market, two companies have turned their attention to what comes next – verifying whether the vaccines provide effective and lasting protection against SARS-CoV-2. Imanis Life Sciences and Siemens Healthineers have both announced the development of their scalable quantitative neutralizing antibody assays, a noteworthy advancement from the +/- results yielded by widely used antibody tests.
With a quantitative test result, physicians and researchers can track neutralizing antibody titers over time to better understand the short- and long-term efficacy of COVID-19 vaccines.
Imanis Life Sciences Announces Improvements and Increased Capacity of IMMUNO-COVTM, a First-in-Class Neutralizing Antibody Test for COVID-19
High-throughput clinical assay detects and quantifies SARS-CoV-2 neutralizing antibodies
ROCHESTER, Minn., Nov. 19, 2020 – Imanis Life Sciences, LLC (“Imanis” or “The Company”) announced today that it has completed validation of its latest improved IMMUNO-COVTM assay, the first scalable, quantitative virus neutralizing antibody test for COVID-19. This validation adds plasma as an accepted sample type, and improves sensitivity, stability and reliability while maintaining high accuracy. The Company also announced that it has been processing samples from its research partners and has completed steps necessary to increase test processing capacity in its CLIA-accredited facility in Rochester, Minn.
“IMMUNO-COV’s performance has been outstanding over a large validation group and across a variety of customer samples,” said Michael Herbert, Chief Commercial Officer at Imanis. “With increased lab capacity and enough manufactured virus on-hand to run over five million tests, we anticipate strong interest in the assay and are ready to expand availability across all areas of critical need.”
Imanis has been processing tests for research partners for several weeks. At this time, its lab is equipped to address large scale testing requirements for:
- Evaluating the relative effectiveness of SARS-COV-2 vaccine candidates in clinical trials.
- Testing healthcare workers and other at-risk professionals with prior SARS-CoV-2 infections to assess the strength and durability of their immunity to COVID-19 over time.
- Physician ordered tests where indicated for patients presumed or suspected to have been exposed to the virus (or a vaccine) more than 2 weeks prior to testing.
IMMUNO-COV detects and quantifies virus neutralizing antibodies, which can prevent the spread of SARS-CoV-2 in the body, the virus that causes COVID-19. Neutralizing antibodies become detectable in the blood approximately 14 days after the onset of infection. IMMUNO-COV was jointly developed by affiliates Imanis and Vyriad, Inc., in collaboration with Regeneron and Mayo Clinic.
About Imanis Life Sciences
Imanis Life Sciences is a leading provider of laboratory assays and research services that can accelerate the development of a broad range of virus-based gene therapies and immuno-oncology drugs. Our mission is to strengthen the pharmacological underpinnings of virus-based therapeutics and to promote the adoption of noninvasive in vivo reporter gene imaging in preclinical and clinical research. Our team of dedicated and passionate scientists (PhD, MSc, BSc) works closely with clients to facilitate their preclinical or clinical-stage virus-based research and development programs. For more information, visit https://imanis-immunocov.com/.
Chief Commercial Officer
Imanis Life Sciences
Study suggests herd immunity to COVID-19 in New York City is low
By Sally Robertson, B.Sc.
November 9, 2020
Researchers in the United States have estimated that the proportion of people in New York City who developed antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during the first wave of the coronavirus disease 2019 (COVID-19) pandemic is around one in eight.
Larry Luchsinger from New York Blood Center (NYBC) and colleagues from Regeneron Genetics Center, Imanis Life Sciences, and Regeneron Pharmaceuticals, Inc. say their findings suggest that background or “herd immunity” continues to be low and that eight months into the US pandemic, it is likely that the proportion of susceptible individuals remains very high, possibly greater than 80%.
The team says the study also suggests that the presence of antibody-based immunity is not necessarily associated with the development of neutralizing antibodies against SARS-CoV-2.
The researchers say the strategy they used to estimate seroprevalence in this study could be leveraged for future rapid assessment of seroprevalence/seroconversion in this cohort to help guide public health decision making.
A pre-print version of the paper is available on the server medRxiv*, while the article undergoes peer review.
Blood Donor Demographics of NYC Metro Area A; Choropleth of donation site locations used for the collection of blood donor samples. Heatmap (gradient bar, top) indicates the frequency of donors collected per site. B; Distribution of NYC Metro area donor age (red bars) compared to NYC demographics (blue bars). Dotted lines represent the best fit to a Gaussian distribution and r2 value represents calculated goodness of fit to distribution plot. C; Gender frequency of NYC Metro area donors (red bars) compared to NYC demographics (blue bars). Chi-square test for goodness of fit to observed (donors) versus expected (NYC demographics) results; * p<0.01 D; Ethnicity frequency of NYC Metro area donors (red bars) compared to NYC demographics (blue bars). Chi-square test for goodness of fit to observed (donors) versus expected (NYC demographics) results; * p<0.01
Serological tests of could be valuable for guiding public health policies
Since the first cases of SARS-CoV-2 were identified in Wuhan, China late December 2019, transmission models have suggested that recovery following infection may provide antibody-mediated immunity against future infection.
Serological tests that can identify individuals who have acquired antibodies against the virus (seroconversion) and the frequency of this seroconversion (seroprevalence) in a population could be valuable for guiding the development of public health policies.
As the infection number continues to rise and vaccine programs are introduced, serologic testing will be crucial for monitoring the development of herd immunity – the point where enough people have become immune, and person-to-person transmission is no longer likely.
However, the tests used for population-wide serological assessment must be reliable, credible, reproducible and high-throughput, say Luchsinger and team.
Furthermore, it is vital to understand the degree of correlation of any given assay’s “reactivity” with the presence of neutralizing antibodies, say the researchers, since only a subset of virus-specific antibodies exhibit neutralizing activity.
“Thus, studies that evaluate serological test designs are necessary to associate a serological result with a probability of immunity,” writes the team. “These data, then, can be used to assist public health officials in modeling projections and in informing policy-making decisions, including the safe ‘reopening’ of cities, states, and regions.”
A range of SARS-CoV-2 antibody assays are currently available, but differences in test characteristics, particularly sensitivity, could lead to variability and potential bias when estimating immunity levels among different locales or subpopulations.
However, two platforms that have been widely cited are in-house enzyme-linked immunosorbent assays (ELISA) and high-throughput serological assays (HTSA), say Luchsinger and team.
What did the current study involve?
New York City (NYC) was one of the first epicenters of the COVID-19 pandemic and had the highest case count per capita in the United States.
“Seroconversion, therefore, is likely to be substantial in a random sampling of NYC residents,” say the researchers.
The team conducted a point-in-time 1,000-person cohort study involving serial blood donors (aged a median of 48 years) in the NYC metropolitan area.
Plasma samples randomly collected from NYBC blood donation centers between June and July 2020 were tested using multiple commercially available assays, including ELISAs and HTSAs.
These were then tested and associated with assays for neutralizing antibodies.
What did the study find?
Among the 1,000 blood donor samples collected, the estimated seroprevalence rate using a test called the Ortho Clinical Diagnostics VITROS 120 Total Ig Test (Ortho) HTSA assay indicated a seroprevalence of 12.1%.
Another test called the Abbott Labs Architect SARS-CoV-2 IgG (Abbott) HTSA assay indicated that the seroprevalence was 10.9%.
The researchers also found that ELISA assays, which are the current gold-standard of serological quantification, corresponded with donor seropositivity as detected by these HTSAs, thereby validating the use of ELISAs in this context.
Importantly, the assays showed that the nature of the antibody-mediated immunity was not invariably associated with the development of neutralizing antibodies. Neutralizing activity against SARS-CoV-2 was wide-ranging and skewed towards slow-to-moderate titers of neutralizing antibodies.
The team says the data suggest that the seroconversion rate was around 1 in 8 among the blood donors since the pandemic began in NYC and that this estimate is in agreement with other reports from state and local departments of health.
What are the implications of the findings?
“Our findings demonstrate a comparable seroprevalence estimate can be discerned using a widely accessible blood donor population and it [is] an important metric during this catastrophic outbreak,” write the researchers.
This strategy can therefore be leveraged in its design for future studies to implement rapid seroconversion/seroprevalence monitoring, they say.
Furthermore, “these conclusions suggest that in the absence of a vaccine, “background” or “herd” immunity continues to be low at four months post commencement, and, now eight months into the US pandemic, it is probable that the susceptible population remains very high, and possibly at ~80% or greater,” the team warns.
medRxiv publishes preliminary scientific reports that are not peer-reviewed and, therefore, should not be regarded as conclusive, guide clinical practice/health-related behavior, or treated as established information.
- Luchsinger L, et al. Seroprevalence of Anti-SARS-CoV-2 Antibodies in a Cohort of New York City Metro Blood Donors using Multiple SARS-CoV-2 Serological Assays: Implications for Controlling the Epidemic and Reopening. medRxiv, 2020. doi: https://doi.org/10.1101/2020.11.06.20220087, https://www.medrxiv.org/content/10.1101/2020.11.06.20220087v1
Transforming the treatment of cancer with oncolytic viruses
Imanis Life Sciences to Present IMMUNO-COV, a First-in-Class Neutralizing Antibody Test for COVID-19, at American Society of Gene and Cell Therapy Symposium
High-throughput clinical assay detects, quantifies SARS-CoV-2-neutralizing antibodies
Imanis Life Sciences is an affiliate of Vyriad Inc.
ROCHESTER, Minn., September 14, 2020 – Imanis Life Sciences, LLC announced today upcoming presentations about the development and validation of IMMUNO-COV™, the first scalable, quantitative neutralizing antibody test for COVID-19. The company will present a technical overview of the assay and host a luncheon presentation at the American Society of Gene and Cell Therapy (ASGCT) COVID-19 Symposium, a virtual event that will be held September 15-16.
In contrast to other antibody tests, the IMMUNO-COV assay specifically measures antibodies in the blood that can block infection by SARS-Co-V-2, the virus that causes COVID19. One of the key ways the immune system fights a SARS-CoV-2 infection is to make a huge number of antibodies that recognize and bind to the surface of the virus in many different ways and at many different sites. Only a small subset of those antibodies — called neutralizing antibodies — can actually prevent the virus from infecting new cells.
The IMMUNO-COV test uses an innocuous virus that mimics SARS-CoV-2 and detects neutralizing antibodies in the blood that can recognize and stop the virus from infecting new cells. Neutralizing antibodies are detectable in the blood typically 14 days after the onset of infection and their levels vary widely from person to person.
Imanis Life Sciences, under a commercial arrangement with Vyriad, is performing the IMMUNOCOV assay in its CLIA-certified laboratory. Mayo Clinic has licensed IMMUNO-COV for evaluating donors in the national COVID-19 convalescing plasma study. Applications for the IMMUNO-COV assay include:
- Assessing neutralizing antibody levels in potential donors of COVID-19 convalescent plasma for treatment of patients infected with SARS-CoV-2 (plasma with high neutralizing antibody titers is preferred).
- Evaluating the relative effectiveness of SARS-COV-2 vaccine candidates in clinical trials.
- Testing healthcare workers and other at-risk professionals with prior SARS-CoV-2 infections to assess the strength and durability of their immunity to COVID-19 over time.
Rianna Vandergaast, Ph.D., the lead IMMUNO-COV scientist at Imanis Life Sciences, will give both presentations at the ASGCT COVID-19 Symposium.
12:00pm-1:00pm central time, Tuesday, September 15 IMMUNO-COV™: An Antibody Test for COVID-19-Neutralizing Antibodies
This luncheon presentation will provide technical information about the assay and focus on its significance, potential applications and ongoing assay research and improvements.
3:48pm-4:00pm central time, Wednesday, September 16 Development and Validation of a High-Throughput Clinical Assay for Detecting SARS-CoV-2-Neutralizing Antibodies.
This is 10-minute technical overview of the development and validation of IMMUNO-COV, as well as further assay development
To attend the free virtual conference, register here.
A recording of Dr. Vandergaast’s presentations will be available on the ASGCT website for 30 days following the symposium.
IMMUNO-COV is a product of Vyriad, Inc., developed in collaboration with its affiliate Imanis Life Sciences, Regeneron and Mayo Clinic.
About Imanis Life Sciences
Imanis Life Sciences is a leading provider of products and services to accelerate development of viro-immuno-oncology drugs. Our mission is to advance pharmacokinetics and imaging, promote widespread adoption of noninvasive in vivo imaging in preclinical and clinical research. Our team of dedicated and passionate scientists (PhD, MSc, BSc) works closely with clients to facilitate their research, from study design, custom products, and consultation. . For more information, visit www.imanislife.com.
About Vyriad, Inc.
Vyriad is a clinical-stage company developing virus-based therapeutics, focusing initially on proprietary oncolytic virus therapies for the treatment of cancers with significant unmet needs. Founded by scientists at Mayo Clinic and the University of Miami, Vyriad programs viruses to selectively attack cancer cells, thereby igniting antitumor immune responses that can complete the process of tumor destruction and prevent disease recurrence. Our lead platforms, derived from either vesicular stomatitis virus or measles virus (VSV), are being evaluated in ongoing Phase 2 clinical trials addressing multiple cancer types. Vyriad and Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) have entered into a broad strategic agreement for the discovery and development of new oncolytic virus treatments for cancer leveraging Vyriad’s VSV platform and Regeneron’s PD-1 inhibitor Libtayo® (cemiplimab) as well as its unmatched antibody discovery capabilities. Vyriad is a privately held company based in Rochester, Minnesota.
Heroes of the Pandemic
BY GAIL ROSENBLUM
Six months now into this perplexing and powerful pandemic, we’ve grown accustomed to seeing our “front line” heroes whenever we venture out and also when we don’t. We see them, masked of course, behind plexiglass at the grocery store, dropping packages at our door, overheating in head-to-toe PPE to reach into our cars to test us for COVID-19. We continue to thank them for their invaluable and brave service. This month, though, we are pleased to bring you a different kind of “front line” hero. They are doctors, scientists, researchers — even a COVID-19 survivor — working largely behind the scenes in labs to track the virus, dig into data, study the efficacy of drugs and antibody tests, all with a common goal: To crack the code on COVID as quickly as possible and get our state and nation back on track. And while it’s un-Minnesotan to say this, we can and should be proud that so many national leaders reside right here in our state.
Senior Scientist, Imanis Life Science, LLC
The body makes antibodies to fight COVID-19 but many of those tiny proteins don’t actually block the coronavirus from infecting a cell. Only “neutralizing antibodies” protect against infection. So Rianna Vandergaast spent much of her spring holed up in labs in Rochester, designing and running experiments on ways to detect neutralizing antibodies. In June, Mayo Clinic announced it would begin offering the first-of-its-kind test that Vandergaast and her colleagues at Imanis Life Sciences and sister company Vyriad designed to detect these difficult-to-spot proteins. The test will be used to see whether people can become infected with COVID-19 more than once, whether plasma from COVID patients can fight infection in others and how well vaccine candidates perform. In other words, she said, “Are those antibodies able to neutralize future virus?” JOE CARLSON
Mayo Clinic to Offer Vyriad Neutralizing Antibody Test
Mayo Clinic has licensed the Vyriad IMMUNO-COV™ antibody test that detects and quantifies neutralizing antibodies, the critical subset of antibodies known to protect against SARS-CoV-2 viral infections. IMMUNO-COV is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect.
Mayo Clinic plans to use a slightly modified version of assay to support the nationwide convalescent plasma exchange study and other COVID-19 research efforts. The test will be available through Mayo Clinic Laboratories in late June.
“We are delighted that Mayo Clinic is moving forward with the test, which will expand the availability of this important new addition to the serology testing landscape,” said Stephen Russell, MD, PhD, Vyriad President and Chief Executive Officer.
Vyriad launched IMMUNO-COV last month and is conducting the test at its CLIA-certified laboratory in Rochester, Minn. Healthcare providers and laboratories may order the test and submit blood samples for analysis to Vyriad. For more information, contact IMMUNO-COV@vyriad.com.
Vyriad and Imanis Life Sciences developed IMMUNO-COV in collaboration with Regeneron and the Mayo Clinic
Scientific Paper Available on Development and Validation of IMMUNO-COV™, Vyriad’s SARS-CoV-2 Virus-Neutralizing Antibody Test
Vyriad and Imanis Life Sciences announced today the publication of a scientific paper on the development and validation of IMMUNO-COV™, a high-throughput clinical test to quantitatively measure SARS-CoV-2-neutralizing antibodies, the specific subset of anti-SARS-CoV-2 antibodies that block viral infection. The paper is available on bioRxiv, a free online archive and distribution service for non-peer-reviewed manuscripts in the life sciences.
The paper is titled, “Development and validation of IMMUNO-COV™: a high-throughput clinical assay for detecting antibodies that neutralize SARS-CoV-2.” bioRxiv accepts non-peer-reviewed articles to facilitate the rapid sharing of new scientific information about COVID-19 and other life sciences areas of research.
The disease-causing SARS-CoV-2 virus uses its spike protein to infect healthy cells and spread throughout the body. The IMMUNO-COV antibody test uses an innocuous virus that has been engineered to carry this SARS-CoV-2 spike glycoprotein on its surface. It analyzes human blood serum to detect only the antibodies capable of ‘blocking’ the action of this spike glycoprotein, thus preventing the SARS-CoV-2 virus from infecting new cells. This is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect. News release.
Vyriad and Imanis Life Sciences developed the assay in collaboration with Regeneron and the Mayo Clinic.
Vyriad Inc. Announces Development of a New Antibody Test to Determine Protective Immunity From COVID-19
Vyriad test detects SARS-CoV-2 virus-neutralizing antibodies
Developed as part of an ongoing collaboration with Regeneron
ROCHESTER, Minn., May 12, 2020 – Vyriad, Inc. announced today that it has completed the development of a serology test to measure protective immunity against SARS-CoV-2, the novel coronavirus that causes COVID-19. The Vyriad IMMUNO-COV™ antibody test detects neutralizing antibodies, the critical subset of antibodies known to protect against SARS-CoV-2 viral infections. The ability to reliably identify these neutralizing antibodies will be critical to the safe re-opening of work, school and social settings. Vyriad and Regeneron jointly developed the test as part of their existing discovery and development collaboration. The test is expected to be available through major CLIA-certified testing labs by the end of May.
The disease-causing SARS-CoV-2 virus uses its spike protein to infect healthy cells and spread throughout the body. The IMMUNO-COV™ antibody test uses an innocuous virus that has been engineered to carry this SARS-CoV-2 spike glycoprotein on its surface. It analyzes human blood serum to detect only the antibodies capable of ‘blocking’ the action of this spike glycoprotein, thus preventing the SARS-CoV-2 virus from infecting new cells. This is distinct from most existing serology tests which do not confirm the virus-neutralizing function of antibodies they detect.
“We believe the ability of our test to accurately identify virus-neutralizing antibodies provides a higher degree of certainty about whether individuals have acquired protective immunity from COVID-19, including in those people who have never had symptoms of COVID-19,” said Stephen Russell, M.D., Ph.D., Chief Executive Officer of Vyriad, a clinical-stage biotechnology company specializing in virus therapies to treat diseases, including cancer. “We believe this is the first commercially scalable test of its kind and could become the gold standard for determining protective immunity, because it detects specifically the antibodies capable of blocking re-infection. Our hope is that this assay will be used to help inform back-to-work decisions for individuals who believe they have been exposed to the virus.”
Since the start of the COVID-19 outbreak in December 2019, experts believe millions of people around the world may have contracted the disease, many with asymptomatic infections or mild infections that go undetected or undiagnosed. People who recover from COVID-19 infection may develop an antibody response to the pathogen, which creates immunological memory and potentially protects them from future exposure to the virus. These antibodies are typically detectable in the blood approximately 14 days after the onset of infection.
“Regeneron is working on multiple fronts to find effective approaches against SARS-CoV-2, including the development of a novel antibody therapeutic that could be used as prevention or treatment for the disease,” said Christos Kyratsous, Ph.D., Vice President of Research, Infectious Diseases and Viral Vector Technology at Regeneron. “We’re encouraged to also be working with our collaborator Vyriad to utilize both companies’ virus engineering capabilities in order to deploy a much-needed testing approach.”
Vyriad has internally validated this assay and is conducting ongoing assay verification studies to continually evaluate assay performance. The assay validation results and methodology have been submitted to the FDA in accordance with regulatory requirements for COVID-19 Emergency Use Authorization.
The test is currently run at Vyriad’s CLIA-approved laboratory in Rochester, Minnesota. Vyriad does not engage in patient services and can only accept testing requests from a referring physician or laboratory at this time. It is anticipated that this test will be commercially available through major laboratories within the next few weeks.
Since October 2019, Vyriad has been working exclusively with Regeneron to research and develop vesicular stomatitis virus (VSV)-based oncolytic virus technologies. This collaboration now includes the IMMUNO-COV™ antibody test, which was developed utilizing the deep scientific expertise of both companies. Regeneron’s proprietary VelociSuite® technologies and Vyriad’s virus engineering capabilities enabled development of this scalable assay in a rapid timeframe.