Lawsuit alleges company sold antibody tests not approved by FDA

LOS ANGELES – Los Angeles County District Attorney Jackie Lacey Friday announced a lawsuit against a company that allegedly sold COVID-19 blood serum tests that were not approved by the U.S. Food and Drug Administration.

The lawsuit alleges Applied Biosciences Corp. sold and marketed the antibody test kits for $35 each and claimed the tests were 96% accurate. In a press release, the company claimed that with a small blood sample, the tests could identify the early or late stages of someone’s antibody levels in less than 15 minutes.

“We’re asking the court to stop these defendants from continuing to market and sell the at-home test kits,” Lacey said. “We’re also seeking civil penalties and restitution for all consumers who bought the test kits. Under the law, we may seek as much as $2,500 in penalties for each violation.”

Antibody tests are a way to examine blood serum to find out if someone has recently recovered from COVID-19, which can be especially helpful to stopping the spread of the virus if the person did not experience symptoms. Health experts say those tests don’t necessarily tell if someone is infectious or not.

“Our lawsuit accuses the company of making false claims that are misleading, unfair, unlawful and quite frankly, dangerous,” Lacey said. “At all times, but especially during this public emergency, consumers should be able to trust that health care treatments … are providing reliable and accurate results.”

Calls and emails to Applied Biosciences’ headquarters in New York were not immediately returned.

The case against Applied Biosciences is the first lawsuit filed by the Los Angeles Joint Coronavirus Task Force during the pandemic, Lacey said.

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