The test, by BioMedomics, was one of about 100 serological tests that the FDA allowed manufacturers to sell beginning March 26, 2020, if the companies self-validated their accuracy. The agency did not require the companies to submit reports of the results of their validation efforts.
More than 100 such self-validated tests have been on the market, raising concerns about their accuracy from the U.S. House of Representatives Oversight Subcommittee on Economic and Consumer Policy, the American Medical Association, the National Institutes of Health (NIH) and a group of independent scientists, which found that a number of serological tests for COVID-19 are performing poorly or inconsistently.
On May 4, the FDA reversed its policy, saying manufacturers of COVID-19 antibody tests must prove the tests’ accuracy to the agency before they can begin marketing them. The agency gave companies already selling tests 10 days to submit their validation information or risk having the tests pulled from the market.
Serological tests are needed to show who has developed antibodies and possible immunity to the virus, although no one has shown how long such immunity may last or how protective it may be. Pressure to increase serological testing has been mounting as more people have recovered from the virus and demands to reopen the country intensify.
BioMedomics did not respond to a request for comment from MassDevice, but BD did.
“BioMedomics has completed development of a second generation of the test and is currently coordinating validation activities,” BD spokesman Troy Kirkpatrick said in an email. “BioMedomics intends to submit a new (emergency use authorization) application to FDA once the second-generation test has successfully completed all validation testing. …
“BD’s collaboration with BioMedomics enables BD customers to have access to a serology test that can detect antibodies in blood to confirm a recent exposure or later stage infection of SARS-CoV-2, the virus that causes COVID-19,” Kirkpatrick added. “BioMedomics developed one of the first point-of-care antibody tests, which could detect this exposure in as little as 15 minutes, and was also one of the first to publish clinical outcomes data for a COVID-19 antibody test in a peer-reviewed publication (Journal of Medical Virology), documenting performance characteristics for its test.”
BioMemodics’ serological antibody test and those self-validated and sold by three other U.S. companies have come under scrutiny by the House subcommittee.
Subcommittee chairman Raja Krishnamoorthi (D-Ill.) sent letters to UCP Biosciences (San Jose, Calif.), BioMedomics (Morrisville, N.C.), Epitope Diagnostics (San Diego) and Premier Biotech (Minneapolis) on April 28, listing the committee’s concerns about the accuracy of the companies’ serological antibody tests. In the letters, Krishnamoorthi said that a study conducted by researchers at University of California San Francisco, University of California Berkeley, Chan Zuckerberg Biohub and Innovative Genomics Institute evaluated the performance of a dozen commercially available antibody tests, including these companies’ tests, and found the results “deeply troubling.”
The letters ask the companies to send the subcommittee their communications with the FDA, validation data for their tests, lists of test recipients and information sent to customers about the tests. The deadline is today.
Premier Biotech said on its website that it is the U.S. reseller of a test manufactured by Chinese manufacturer Hangzhou Biotest Biotech Co. Ltd. Hangzhou Biotest Biotech has submitted an emergency use authorization (EUA) application to the FDA and both Premier Biotech and Hangzhou Biotest are in contact with the National Cancer Institute regarding the independent validation study, according to a spokesperson for Premier Biotech.
“The product has been independently studied by scientists at Stanford University and other leading institutions,” Premier Biotech CEO Todd Bailey said in a statement. “These independent tests have shown strong product performance for a product that is dearly needed. Premier Biotech strives to play a part in responding and providing solutions to all stakeholders in this crisis. We have always conducted our business with the greatest integrity, and we will continue to meet those high standards in the days ahead.”
In a May 6 statement on its website, Epitope Diagnostics faulted the research into its test’s accuracy by scientists at the University of California San Francisco, University of California Berkeley, Chan Zuckerberg Biohub and the Innovative Genomics Institute.
“The study’s findings did not correlate with the results of the clinical testing listed on the product instructions for use,” the company said. “While we appreciate the initiative and advocate the nature of the study, the researchers failed to follow requirements and protocol as listed in the instructions for use.”
UCP Biosciences and BioMedomics did not immediately respond to requests for comment.