Devices

Bipartisan Bill to Expand Diagnostic Testing

Bipartisan legislation has been introduced in the House and Senate to increase the diagnostic capabilities of health laboratories across the U.S., in part to better respond to emerging public health threats such as the novel coronavirus. The bill follows complaints from public health officials that a current FDA policy requiring laboratories to get prior agency approval before they test patients for the coronavirus was impeding their ability to quickly diagnose and quarantine if necessary potential Covid-19 cases in the U.S. FDA has temporarily lifted the pre-approval requirement so that hospitals across the country can begin testing patients for the virus. Part of the legislation would make the change permanent.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act would create a new product category for diagnostic and lab tests, putting their review and approval under the guise of FDA going forward, according to Rep. Diana DeGette (D-CO), one of the measure’s sponsors. She says (contains links to bill text and bill summary) the bill also would create a new system for hospitals and labs to use to submit their tests electronically to FDA for approval, intended to significantly speed the amount of time it takes FDA to approve such tests and also increase the tests’ quality and reliability. And it would establish a program to expedite the development of new diagnostic tests that can be used to address a current unmet need for patients.

Other sponsors are Rep. Larry Bucshon (R-IN). Senate sponsors of an identical bill are Sens. Richard Burr (R-NC) and Michael Bennet (D-CO).

AdvaMed is praising the legislation for calling for “smart diagnostic regulatory reform that will incentivize and speed the development of the advanced, reliable tests that benefit the patients we serve.”

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