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Friday, Apr 12, 2024

Genalyte Receives Emergency Approval for Antibody Test

Healthcare analytics and diagnostics company, Genalyte Inc. received emergency use authorization from the U.S. Food and Drug Administration (FDA) for its rapid COVID-19 antibody test, SARS-CoV-2 Multi-Antigen Serology Panel on Oct. 15. The Sorrento Valley-based company touts its antibody test — which gives results in about 15-20 minutes — as an integral part of the bigger solution to combating the coronavirus pandemic.

Precise Antibody Detection

Cary Gunn, who founded Genalyte Inc. in 2007, said the development of the COVID-19 antibody test is an “evolution” of the company’s core technologies and its overall mission to streamline lab testing for patients. The new antibody test is based off of Genalyte’s Maverick Detection System which was approved by the FDA in 2019.

Unlike other antibody tests, the Maverick Detection System tests for SARS-CoV-2 antibodies while also looking for 13 viral antigens that are similar but do not cause the novel coronavirus. Some of these include seasonal coronaviruses that lead to colds, and other serious respiratory illnesses such as SARS and MERS.

“We test for all coronaviruses and are able to use an algorithm to make sure it’s SARS-CoV-2,” Gunn explained. “SARS-CoV-2 is 90 percent identical to other coronaviruses and many of the proteins it is made of are the same. But, at the genetic level it’s about pattern recognition.”

Early in the pandemic, many antibody tests were unsuccessful because they lacked the precision to identify the specific SARS-CoV-2 antigens, explained Gunn.

However, the machine learning algorithm of the Maverick technology allows for Genalyte’s rapid tests to produce more accurate results by targeting the COVID-19-causing antibodies on a molecular level.

Timing is Everything

Another key element of Genalyte’s test is that it can produce results months after a patient’s initial infection which expands the narrow window of time for a test to tell you if you had COVID, Gunn said.

According to the founder, whether it is a PCR or rapid antigen test, patients have a narrow window of about a week to detect the active virus and about 30-40 percent of the time these tests produce a false-negative.

Genalyte’s newly appointed CEO, Ashraf Hanna explained that overall, antibody tests play an important role in how society can open up in the long term. If you find out after-the-fact that you were infected with COVID-19, Hanna said it can help people understand if they have some level of immunity to the virus.

“The viral [antigen] test answers the question of do I have the virus now and the antibody test answers the question of did I have the virus in the past?” said Hanna, who has an M.D. from the University of Massachusetts.

Back in July, the privately-held company set up a testing site at the Del Mar Fairgrounds in an effort to expand its serology antibody testing to San Diegans.

Hanna theorized that in a world of limited vaccine resources, this kind of antibody test could allow for an effective distribution of vaccine resources to those who do not have SARS-CoV-2 antibodies. He said it can also reflect the effectiveness of a vaccine because it would allow researchers to see the presence of antibodies in a person who was not previously infected with COVID-19.

With the new FDA approval of the antibody test, Hanna said they are looking at making these tests available in settings where they can have an impact such as universities and workplaces.

In the long term, Genalyte has its sights set on having its rapid, point-of-care testing become a normal way of producing accurate lab results fast right within a doctor’s office.


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