Rochester scientists develop first-of-its-kind antibody test to detect protective immunity
Scientists at Vyriad have developed a new serology test capable of detecting neutralizing antibodies to determine a person’s immune defense against SARS-CoV-2, the virus that causes the disease Covid-19.
The Rochester-based biotech firm is now collaborating with the pharmaceutical company Regeneron to make the test commercially available through major laboratories by the end of May.
Dr. Stephen Russell, CEO and co-founder of Vyriad, said the test’s ability to pick up on the specific antibodies capable of blocking re-infection may make it the “gold standard” for determining protective immunity.
“There are many, many different antibodies, some of which are capable of neutralizing the virus… and it’s those antibodies that neutralize the virus that are the important ones. They tell you whether you are more likely to be protected from reinfection or not,” Dr. Russell explained in an interview Tuesday. “This assay specifically measures neutralizing antibodies as opposed to just antibodies generally. It’s looking at a functional aspect of those antibodies — can they neutralize the virus?”
With clinical studies showing reliable results, the company is partnering with Regeneron to make the Vyriad SARS-CoV-2 Neutralizing Antibody Test the first commercially-scalable assay of its kind.
In doing so, the companies — which last fall inked a multi-million-dollar research collaboration and licensing agreement — hope to make the tests available worldwide. The tests could then potentially be used to inform decisions around when people are able to return to work and school.
“Having the partnership with Regeneron gives us this much bigger reach in terms of getting attention of the people who can take this assay and make it broadly available to many people,” said Russell.
Vyriad first started looking into ways it could respond to the coronavirus in February once scientists in China began making data related to SARS-CoV-2 available to the world. Researchers at the Rochester lab were able to build the reagents into an engineered vesicular stomatitis virus (VSV) platform normally used to infect and kill cancer cells. The experiment was a success and by late February, Vyriad had generated a virus incorporating the SARS-CoV-2 coat protein that could be used as the basis of a test.
“We then very rapidly developed the test,” said Russell, “because we could see there was a need for these tests to discover what type of immunity and what level of immunity people had after being exposed.”
Within weeks, Vyriad began running a clinical study to validate the new test. The company set up a tent outside of its facility in northwest Rochester with help from Olmsted Medical Center to collect negative control samples. A second testing site was set up in New Jersey, which has been a hot spot for the coronavirus, for positive samples.
The results and methodology of the study have since been submitted to the FDA in accordance with regulatory requirements for Covid-19 Emergency Use Authorization. Russell said there have also been discussions with Mayo Clinic, where he also employed as a researcher, about the possibility of the institution using Vyriad’s serology assay.
However, despite the rapid nature in which the test was developed — a couple of months compared to what would normally be six months to a year — Russell cautioned it will take time to learn how it can be used most effectively. He noted that while early results are promising, the test is more convoluted and takes longer to get to a result than other serology assays.
“Initially, I think there’s going to be a period of exploration of finding: how does this actually help us?” said Russell. “Is it going to be helpful for front line workers who really do need to know whether they have protection? Is it going to be helpful for cancer patients or patients with other health problems who are going to be at a significantly higher risk of re-infection by the virus? And, is it going to be important as a way of testing people to see whether they can be plasma donors? These are some of the questions that I think this assay can potentially help us address.”
Sean Baker is a Rochester journalist and the founder of Med City Beat.
Cover photo licensed via Getty
