Dive Brief:

• A bipartisan bill overhauling how diagnostic tests are regulated was recently reintroduced in Congress, and “there is a path to getting it over the finish line this year,” AdvaMed CEO Scott Whitaker said in a statement. 
• U.S. Representatives Diana DeGette, D-Colo., and Larry Bucshon, R-Ind., reintroduced the VALID Act (Verifying Accurate, Leading-edge IVCT Development) on March 29. 
• The bill would bring in-vitro diagnostics and laboratory-developed tests under one regulatory framework, a move supported by some medical device groups, including AdvaMed. But it has also faced pushback from organizations that say it will be costly to laboratories and detrimental to patient care.

Dive Insight:

Legislators introduced the VALID Act twice last year, proposing an updated version of the bill as part of the year-end spending package in December, but ultimately failed to pass it amid pushback from groups that provide testing in academic medical centers. Various iterations of the bill have been proposed since 2018. 

The VALID Act would create a separate category of products for tests from medical devices. It would also clarify the Food and Drug Administration’s authority to regulate laboratory-developed tests, which have previously been exempted from clearance or approval requirements through enforcement discretion. Tests that are already on the market would not fall under the new regulatory requirements. 

“Modernization of the regulation of all LDTs and IVDs under a single, diagnostic-specific regulatory framework under the Food and Drug Administration is needed to foster innovation, embrace scientific advances, and ensure consistency in development, accuracy and reliability of all tests, for the advancement of patient care and public health,” Zach Rothstein, executive director of AdvaMedDx, AdvaMed’s diagnostic division, said in a statement. 

AdvaMed did not indicate why the bill would have a better chance on its third attempt at passage.

The bill also would create a program to expedite the review of any diagnostic test developed to address an unmet need for patients, and a carve-out was added in December to exempt certain clinical laboratories at academic medical centers.

But in a December letter, groups including the American Association for Clinical Chemistry, Association for Molecular Pathology, and the American College of Medical Genetics and Genomics said the change did not address their concerns and “fails to meaningfully give these institutions the ability to provide necessary care to patients.”

Opponents of the bill said that it would stifle innovation, constrict access to patient care and duplicate existing federal requirements overseeing laboratory quality.

The American Clinical Laboratory Association (ACLA), which represents several commercial laboratories, said its position is that any regulation of lab-developed tests must be done through legislation. Although the trade group did not take a position on the VALID Act when it was introduced last year, it worked with the bill’s co-sponsors.

“Should VALID advance through the legislative process this year, ACLA again stands ready to engage constructively to provide expertise and technical assistance,” ACLA wrote in an emailed statement.

This article has been updated with comments from the American Clinical Laboratory Association.