Dive Brief:

• A former FDA chief scientist has criticized the agency’s handling of antibody tests, accusing the agency of unleashing “chaos” with its initial light-touch approach to regulating the field.

• At a House subcommittee video hearing on Tuesday, Jesse Goodman said FDA’s decision to allow developers of COVID-19 antibody tests to self-validate their products led unqualified entities to flood the market.

• FDA has since changed its approach but is moving too slowly for some members of Congress. Rep. Raja Krishnamoorthi, the Democrat who chairs the subcommittee, urged the agency to accelerate the review of the almost 200 serologic assays still on the market and recall “junk tests.”

Dive Insight:

In mid-March, FDA began allowing developers of serologic assays, which test for antibodies against the SARS-CoV-2 coronavirus, to self-validate products and bring them to market. The agency asked the companies to inform it of their actions and ship tests with a disclaimer that they had not undergone regulatory review and should not be used to make diagnoses without other evidence. 

Within weeks the policy had caught the attention of the House Subcommittee on Economic and Consumer and Policy, which wrote to FDA and the Centers for Disease Control and Prevention to raise concerns about the accuracy and promotion of antibody tests. 

Goodman, now director of the Center on Medical Product Access, Safety and Stewardship at Georgetown University, articulated those concerns in forceful terms at the subcommittee hearing.

“FDA unfortunately opened the door to widespread marketing of COVID-19 serology tests by commercial manufacturers, essentially without any review, regulatory framework or control. The chaos that ensued demonstrates why we have an FDA to ensure our medicines and diagnostics are safe. Both qualified and unqualified entities flooded the market,” Goodman told the subcommittee. 

The agency has recognized that its hands-off approach to the regulation of antibody tests caused unintended consequences, noting in an update last month that “a concerning number of commercial serology tests are being promoted inappropriately.”

FDA has since revised its approach, leading Krishnamoorthi to say the “improved policy will literally save lives.” However, while the agency has begun the process of pulling inaccurate tests from the market, Krishnamoorthi sees more work to do and wants the FDA to up the pace. 

He noted nearly 200 tests still on the market that did not go through the agency.

"FDA must complete its review quickly, recall junk tests and ensure that people only use quality tests for the right purposes,” Krishnamoorthi said. Echoing recent CDC guidelines, experts who testified before the subcommittee said the right use for antibody testing is currently population-based prevalence studies, not to show if an individual is immune. Other people contend antibody tests can play a role in reopening economies.

Against the backdrop of that debate, FDA is continuing to grant emergency use authorization to new antibody assays. On Monday, FDA authorized two assays from Siemens Healthcare Diagnostics. One of the assays runs on Siemens’ Dimension Vista System. The other assay runs on Siemens’ Dimension EXL integrated chemistry system. 

Both systems achieved positive and negative percent agreements of almost 100% when used on samples taken more than 14 days after a patient was diagnosed with SARS-CoV-2 infection.