Senate Committee to Conduct Hearing on LDTs, Precision Medicine

The Senate Health, Education, Labor and Pensions Committee will hold a hearing Sept. 20 on laboratory-developed tests in the era of precision medicine.

The FDA is expected to issue final guidance on LDTs this year, following draft guidance on the subject published in 2014. Currently, the FDA exercises discretion in the premarket evaluation of LDTs, but is expected to implement a new regulatory framework as molecular-based tests see broader use in guiding higher-risk clinical treatment decisions.

In November 2015, the House Energy and Commerce Subcommittee on Health held its own hearing on government regulation of LDTs, with testimony from Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, and Patrick Conway, chief medical officer of the Centers for Medicare and Medicaid Services, which oversees laboratory standards. Shuren noted that the law granting FDA authority over the tests is over 40 years old, and the science behind them has changed with the advent of personalized therapies.