FDA’s lax rules on coronavirus blood tests open US market to dubious vendors

Caroline Humer, Joseph Tanfani & Roxanne Liu

Another vendor, David Melman, of Tel Aviv, recently sent Reuters an email and press release promoting an “accurate, fast, affordable, easy-to-use” antibody test “designed for everyone at home, providing results within a few minutes.”
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.
In response to questions from Reuters, Melman said he intends to perform “research and evaluation” on the kit before distributing it and that he would sell the kit for home use in the United States only if it received an EUA from the FDA.
A fight between two would-be distributors – both of whom had previous run-ins with the law – illustrates the race to cash in on the new testing marketplace.
Edward Joseph Eyring, a 52-year-old former colorectal surgeon in Utah, set up a company and a website in March offering antibody test kits under the name CoronaCide. He notified the FDA of his intent to sell and began talking with potential partners. These included businessman George Todt, who was working as a consultant for a California startup called Wellness Matrix, a publicly traded company.
Todt proceeded to market CoronaCide kits on his own: “Home test kits now! Approved by FDA,” he tweeted on March 19. After National Public Radio reported the claim, the U.S. Securities and Exchange Commission (SEC) suspended trading in Wellness’ stock.
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.”
Todt could not be reached for comment. A lawyer for Wellness, William Dailey, said in a statement to Reuters that the company did nothing wrong and wasn’t involved in Todt’s actions.
Eyring and Todt each have separate histories of defrauding investors.
Todt was sued by the SEC in 2005 for two stock manipulation schemes. In a judgment, he was fined $130,000 and ordered to pay $1.2 million in restitution.
Eyring allowed his medical license to lapse after he stipulated to making clinical errors and violating accepted professional and ethical standards in 2010 and did not complete the terms of his settlement, Utah state records show.
In 2017, he pleaded guilty to “a pattern of unlawful activity” to resolve charges in Utah that he lured investors into a fraudulent African gold trading venture. In a plea agreement, he said he would pay $473,039 in restitution. He was placed on probation, which ended last month – two weeks before he formed CoronaCide.
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.
In written responses to Reuters, attorney Hopen said Eyring regrets that he and his investors lost money and has done his best to repay his debts.
Though virtually unrestricted by the FDA, many antibody test distributors in the United States have run into obstacles posed by China’s export policy.
After European countries criticized the quality of China’s coronavirus tests, China adopted a new policy on April 1 that holds up exports of tests until the products have a certificate from the country’s regulator, the National Medical Products Administration.
Thus far, China has only certified about a dozen of the 90 China-made antibody tests on the FDA list of prospective sellers, leaving many U.S. distributors without kits to sell.
This past weekend, however, China’s commerce ministry said it would loosen those restrictions. It would allow domestic manufacturers to export test kits, provided an authorized trade association verifies that the tests are approved for use in the importing countries.
It was not immediately clear how the move would affect exports to the United States, since FDA approval is not required for antibody tests.
Some medical experts and policy makers say that as the market expands and the stakes grow higher for the tests, the U.S. regulator needs to take on a more assertive role.
Historically, “the FDA has been there as a bulwark for accuracy and reliability,” said William Schaffner, an infectious disease professor at the Vanderbilt University School of Medicine. “If they give up that role, that opens the door to all kinds of mishaps.” -Courtesy: Reuter

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