This story was updated July 10.
Greenville-based Arcpoint Labs is spearheading another COVID-19 test to add to its repertoire, an antibody test that not only detects COVID-19 antibodies in the blood but also how effective they are in holding off the virus.
The test, known as the Tru-Immune Test by Ethos Laboratories, one of Arcpoint’s partners, is known as a neutralization assay and registers a customer’s immune response to the virus on a scale from 1 to 100 after a viral spike protein — but not a live virus — interacts with synthetic cell receptors and potential antibodies, Dr. Chris Cherubino, medical director of ArcPoint Labs, said in an email.
The test awaits emergency-use authorization approval from the U.S. Food and Drug Administration, but if and when the test hits the market, it will be a “game changer,” especially in a reopened economy, Arcpoint CEO John Constantine told GSA Business Report in late June.
“It’s going to be the test that after you have been exposed, basically, it’s going to tell you a protection score,” Constantine said. He added that most existing antibody tests on the market only detect specific antibodies associated with COVID-19 on the assumption that those antibodies will produce immunity.
“The problem with that is that it would identify whether or not you had those, but nobody actually knows — because we haven’t had enough time to study it — what those antibodies actually do. Do they actually prevent you from getting it again?” he said.
Instead of answering what is in a client’s blood sample, the lab’s new test instead answers how someone’s blood does when it reacts to the protein the virus uses to invade human cells.
“It’s the first test of its kind. It used to be a test only reserved for R and D (research and development), but thanks to our lab partner, Ethos, something that used to take days and was very, very expensive to run, now takes hours and is relatively inexpensive,” he said.
Based off current numbers, the test will cost $250 for consumers, which Constantine said is much less than the several hundred-dollar price point of similar tests used in the research and development field. Currently, Arcpoint and Ethos are looking into how long antibodies detected by the test continue to neutralize the virus.
“This is kind of becoming the gold standard testing outside of the United States,” Constantine said.
Duke University’s extension campus in Singapore recently launched a study on neutralization antibody testing, which has also been launched by the Mayo Clinic in select labs, blood banks and biopharma companies. Still, Constantine argues that few programs are geared toward a consumer base at this point. He hopes to tap into a market of employers managing close-contact workplace environments where social distancing measures might be difficult to close to impossible.
“For an employer to provide that as a service to employees is going to be very, very valuable. And even better, if you have employees that are going to be interacting on the front lines with consumers or the general population, why wouldn’t you want to put your employees that have the higher protection scores on the front lines to interact with those consumers?” he said.
Arcpoint also offers PCR-viral testing and antigen testing to consumers and employers. Constantine said that while the PCR-viral test has been approved for back-to-work verification by the Centers for Disease Control and Prevention following a confirmed positive case of COVID-19 and tends to be in wider use, antigen testing has the upper hand in terms of timing.
Employees who stay home because they think they could have been exposed but are not showing symptoms would be able to get an almost instantaneous reading from an antigen test, according to Constantine. A negative antigen reading could help employers and employees bypass the several-day wait of a PCR-viral test, since all antigen tests are processed in-house at ArcPoint’s lab.
The PCR-viral test might carry more weight on the other hand for both consumers and employers if symptoms are present since, according to an Arcpoint representative, the antigen test has yet to be approved as a back-to-work test for employees who recently tested positive for COVID-19.
“If you have symptoms, don’t use the antigen test, use the PCR test. If you think you’re sick — even a headache, even a tickle in your throat — that kind of thing, if you have symptoms, use the viral test,” Constantine said.e