Healthcare groups are urging lawmakers to revisit legislation that would overhaul how diagnostics are regulated in the U.S.
AdvaMed, the American Society of Clinical Oncology, the Pew Charitable Trusts and other groups sent a letter on Monday to the leaders of the House Energy and Commerce Committee and the Senate Health, Education, Labor and Pensions (HELP) Committee, asking them to include the legislative draft in a year-end spending package.
“We are concerned about longstanding regulatory issues that will jeopardize the advancement of the next generation of diagnostics and, thus, patient outcomes,” they wrote. “To address these concerns, which have been recognized by administrations of both political parties, we urge you to support the VALID Act discussion draft currently under review by the committee and include it on an end of year appropriations package.”
The VALID (Verifying Accurate Leading-edge IVCT Development) Act would bring in-vitro diagnostic tests and lab-developed tests (LDTs) under one risk-based framework, closing a loophole where tests made and used in a single laboratory were exempted from regulatory oversight. Infamously, Theranos sold its faulty blood tests as LDTs, though it isn’t the only company to take this strategy. The latest version of the bill includes a carve-out for academic medical centers, which may develop and use LDTs as part of patient care.
Legislators have been working on the VALID Act for years. A bipartisan draft had been included in the Senate HELP Committee’s FDA user fee package, but was slashed from the final version that passed Congress in late September. At the time, leaders of both committees working on the bill said they planned to revisit the diagnostic bill before the end of the year.