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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.