Earlier this week Cellex became the first company to gain an FDA Emergency Use Authorization for a serology test. The test was designed to identify specific antibodies in the blood linked to coronavirus, which means it can be used to identify past coronavirus infections.
Before this test, the products on the market were designed to detect or diagnose if someone currently has the virus.
According to the FDA, the designation is specifically for the “Qualitative detection of IgM and IgG antibodies against SARSCoV-2 in serum, plasma (EDTA or citrate), or venipuncture whole blood from individuals suspected of COVID-19 by their healthcare provider."
Currently the authorization is limited to specific laboratories. The test is not meant to be used to determine whether or not a person is positive for the virus.
"Cellex’s labeling notes that test results from this serology test should not be used as the sole basis for diagnosis and can only aid in the diagnosis of patients in conjunction with a medical review of symptoms and results of other laboratory tests," the FDA wrote.
When the virus first hits, a patient’s body is still developing antibodies in the early days of the infection. That means that serology tests can provide negative results if administered too early. The other issue is that test results could be positive if a person was once infected with the virus but is no longer ill, according to the agency.
WHY IT MATTERS
According to the World Health Organization’s latest reports there are 972,640 coronavirus cases worldwide. To date the United States has the highest recorded cases with 213,600. Since the virus came to the US there has been a dearth of tests available. While a slew of diagnostics has come onto the market, many were discussing the importance of serology tests as well.
"We were never able to get to strategy where we were doing containment and contact tracing unfortunately. Now we are in a big mitigation phase,” Boston Children's Hospital's Chief Innovation Officer John Brownstein, said during the MassChallenge coronavirus innovation summit last week. “That is why of course understanding the illness at the community level is really important, then we can understand hot spots that are emerging and what we need to do in terms of how much social distancing we need to enact... The big question for us is that if there wasn't a test, but there was an illness, how do you know if you've actually recovered? This is where broad scale serology tests are really important. So being able to detect if you once were infected. We could start thinking about doing that at scale, protecting those that are vulnerable while the rest can start to head back to work."
THE LARGER TREND
Since January, the company has worked with more than 230 test developers – who have either already submitted requests for FDA emergency authorization of their product or are expected to submit. It also specifies that 22 have already been granted authorization.
One of the most notable of these new testing kits is Abbott’s ID Now COVID-19. The firm boasts of being able to produce 50,000 tests per day. The company announced that it plans on producing five million tests a month.
Cellex is the first serology product to go through the proper EUA of the FDA; however, earlier this week Bodysphere falsely announced that it had landed an EUA for its rapid COVID-19 serology test. The company later issued an apology citing the announcement as a misunderstanding on the part of Bodysphere.