‘They replace windows and do window cleaning’: Amid the coronavirus pandemic, a medical consultant said he was bombarded with inquiries from American firms who saw an opportunity in selling tests to determine virus immunity
FILE PHOTO: A Detroit resident is tested for free for the coronavirus disease and antibodies at the Sheffield Center in Detroit, Michigan, U.S., April 28, 2020. REUTERS/Rebecca Cook
Pounded by criticism for a delay in expanding diagnostic tests for coronavirus infection, the FDA has swung in the opposite direction in overseeing tests for coronavirus immunity. This take-all-comers approach, Reuters found, has provided an entree for questionable vendors and middlemen — including an electronics salesman hawking an unauthorized home test kit and a former physician convicted in a fraudulent gold-peddling scheme.
The agency has said it is working with the National Institutes of Health and the Centers for Disease Control and Prevention to validate tests, including tests already on the market. It is unclear how many antibody test kits have been distributed for sale in the United States. “When we become aware of these issues, we have and will continue to take appropriate action,” she said, including rejecting tests at the U.S. border.
A team of scientists in California and Massachusetts recently evaluated 14 blood antibody tests now on the market and found significant variation in their performance. But “if you want good quality, are not easy to make,” said Alberto Gutierrez, who led the FDA’s office overseeing diagnostic testing from 2009 to 2017. “They do require a fair amount of expertise.”
Chockalingam “Palani” Palaniappan, Ortho’s chief innovation officer, said the EUA approval process took about a week, but nonetheless was based on a substantial amount of data, including validation of about 400 test samples.Without a rigorous FDA approval process or enough trusted suppliers, hospitals and others in need of antibody tests say they are left to weed out the good products from the bad.
In one case, a distributor called BodySphere claimed in a Business Wire release that it had access to a test that had already been approved for emergency use as a “two-minute” coronavirus “diagnostic” test. BodySphere told Reuters its supplier was Safecare Biotech Co Ltd, based in Hangzhou, China. Melman, who identifies himself on LinkedIn as a sales representative for an electronics firm, has taken on a new title: chief executive of a company called COVI-Labs. He claimed in his pitch that his company’s test had received “pre-EUA approval” for the home test - impossible because the FDA does not allow this type of test.
On April 8, Eyring filed a federal lawsuit alleging that Todt and Wellness pitched CoronaCide kits without his permission and knowing they weren’t approved for home use. The trademark suit says those actions damaged CoronaCide - a company that Eyring’s lawyer, Anton Hopen, told Reuters was intended to help customers “better cope with the COVID-19 pandemic.”
He will “take advantage of anybody and everybody he can,” said Carolann Fredericks, a nurse in Poughkeepsie, New York, now helping to care for critically ill coronavirus patients. A former friend of Eyring, Fredericks gave Eyring $200,000 for the gold deal, according to an affidavit in the case.
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