Dive Brief:

• After holding a series of meetings with stakeholders and adding Sen. Richard Burr, R-N.C., as a new lead sponsor, Congress is working toward releasing an updated Leading-edge IVCT Development, or VALID, Act in the coming months, multiple sources familiar with the issue told MedTech Dive.
• The legislation, which aims to overhaul how in vitro diagnostics and laboratory developed tests are overseen by creating a single regulatory umbrella, has led to a skirmish between the clinical laboratory industry, diagnostic manufacturers and patient advocates. But despite their differences, all players, including the FDA, appear to still be pushing towards a bill as precision medicine continues to grow.  
• But American Clinical Laboratory Association President Julie Khani indicated the legislation still has a long path ahead, calling it "certainly not the final product" in a multiyear process, speaking at the Next Generation Dx Summit last week. AdvaMedDx Executive Director Susan Van Meter said the trade lobby has "provided extensive comments and a red line" to lawmakers.

Dive Insight:

Both Khani and Van Meter praised the inclusion of a pre-certification program in the draft of the VALID Act but indicated more clarity and predictability around the idea will be needed before the legislation is ready to move forward.

"There are a lot of questions about it, but there's real interest there," Khani said. "The challenge, of course, is in the details."

Burr signed on as the lead Republican sponsor after Sen. Orrin Hatch retired this year.

Friends of Cancer Research argued in a recent white paper the current regulatory scheme results in a bifurcated system in which patients and doctors deal with "variability in both accuracy and precision" of tests, despite many expecting all tests are "equally accurate and interchangeable."

"Diagnostic regulatory reform is extremely important and we hope that Congress will move forward quickly for the sake of patients," CEO Jeff Allen said in a statement. "It is vital that all diagnostic tests demonstrate adequate analytical and clinical validity, and we believe this is possible through a single and flexible regulatory pathway through the FDA to ensure test quality."

Last April, the agency exercised its oversight muscle, issuing a warning letter to Virginia-based Inova Genomics Laboratory for offering laboratory developed tests marketed as predictive of individual patient response to certain drugs such as antidepressants. 

Then FDA Commissioner Scott Gottlieb pressed lawmakers to move the legislation forward in his last weeks in office, but progress has inched along since. The agency has offered substantial technical assistance throughout the legislation's development with large portions adopted by lawmakers in the latest version of the bill unveiled last December.

"Although FDA supports a legislative solution that advances public health and looks forward to working with Congress, patient groups, and others on that solution, we cannot comment on our interactions with Congress on the VALID Act," an FDA spokesperson told MedTech Dive in an email.

FDA's breakthrough device designation has seen sizable interest from diagnostic makers; of the 156 breakthrough designated devices, 50 are diagnostic products, according to FDA's Katherine Donigan, acting deputy director of personalized medicine and molecular genetics at the Office of In Vitro Diagnostics and Radiological Health.

The FoundationOne CDx test to detect genetic mutations in solid tumors was the first breakthrough designated in vitro diagnostic to receive marketing authorization, she said at the Next Generation Dx Summit, and more are expected.