ON "60 MINUTES" SUNDAY: FEDERAL OFFICIALS CONTINUED TO ALLOW THE DISTRIBUTION OF COVID ANTIBODY TESTS THEY KNEW WERE FLAWED

Congress Investigating Why the FDA Didn't Regulate the Antibody Tests Flooding the Market during the Pandemic

Federal officials failed to immediately stop the distribution of many COVID-19 antibody tests they knew were flawed, leading to inaccurate data about the spread of the virus. Congress is now investigating why the FDA did not review the tests it allowed to be distributed widely throughout the U.S. Sharyn Alfonsi's three-month investigation into the faulty tests will be broadcast on 60 MINUTES, Sunday, June 28 (7:00-8:00 PM, ET/PT) on the CBS Television Network.

COVID-19 diagnostic kits were in short supply when the pandemic broke out. An alternative test to detect the presence of antibodies in blood was sold as a way to indicate who was exposed to the virus at some point and could now be immune. Such tests would help officials track the disease and determine when it might be safe to begin opening up the economy. The FDA said it would allow the antibody tests to enter the U.S. market and would do so without a formal review. Over 200 companies hit the market with the tests.

Laredo, Texas wound up getting thousands of antibody test kits from a Chinese company. The untested kits were then tested by the city's health director, Dr. Hector Gonzalez, who found the tests accuracy to differ wildly depending on when it was given and how long after a person was exposed to the virus. The small sample he tested was only about 20 percent accurate. "We had such high hopes to test... we were ready to do public drive-through testing... Now we couldn't. We were on hold," recalls Gonzalez.

Laredo officials reported the faulty tests to federal agents at homeland security, and officials came to town to seize the tests and start an investigation, but the federal government did little to halt the spread of other un-proven antibody testing kits.

Dr. Alex Marson, an immunology researcher at the University of California, San Francisco, decided to test a sample of the kits when he learned a friend had tested herself with one. He was concerned there were too many tests on the market and too little information. He and Dr. Patrick Hsu, an assistant professor of bio-engineering at U.C. Berkeley, conducted their own analysis with the help of 50 researchers on tests from across the globe. "We saw a range, saw that some were closer to what we hoped for and others were farther off," Marson tells Alfonsi. And he cautions that even the most reliable antibody tests aren't fool-proof, because antibody levels sufficient to give immunity still aren't known.

It took 50 days for the FDA to reverse its course on antibody tests. In May, it began requiring test developers to apply for emergency authorization and submit data to show their tests worked. It was too late, says Rep. Raja Krishnamoorthi. He is investigating the FDA for not regulating the antibody tests. "Fraudulent tests flooded the market. Hundreds and hundreds of tests taken by hundreds of thousands, if not millions of people," says the Illinois Democrat. All companies had to do to get their tests to the U.S. market was state they were self-validated. "When you open the floodgates to virtually any product being sold by anybody, well, guess what? Shysters, scam artists, and people who are preying on unsuspecting consumers enter the fray," says Krishnamoorthi.

It took almost three months before the FDA started pulling tests off the market, but by then, many American municipalities had already used the tests to determine whether they could send essential workers like EMTs, policemen and firemen back to work. One of the more than 40 tests removed by the FDA was the one Dr. Gonzalez prevented from being used in Laredo. Suppose he hadn't tested them? "We wouldn't have a true indicator of the level of infection. The public deserves for us to give them something that's valid," he tells Alfonsi.

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