LDTs

Laboratory Developed Tests: The VALID Act is Back

With all the attention commanded by the coronavirus crisis, a potentially huge development affecting the future of the lab industry has flown under the radar. What’s at stake is the issue that has been at the center of the industry’s agenda for nearly a decade: FDA regulation of laboratory developed tests (LDTs). Here’s the rundown of recent developments.

The New VALID Act

In early March, legislators in the U.S. House of Representatives and Senate introduced a bill outlining a modernized framework for LDT regulation. U.S. Reps. Larry Bucshon (R-IN) and Diana DeGette (D-CO) introduced the bipartisan legislation to regulate in vitro clinical tests (IVCTs). The re-introduced legislation, the Verifying Accurate Leading-edge IVCT Development Act (VALID), would create a new product category for diagnostic and lab tests to be reviewed and approved by the FDA. An identical version of the bill also was introduced by U.S. Sens. Richard Burr (R-NC) and Michael Bennet (D-CO).

Prequel to VALID

Because lab tests weren’t part of the original FDA legislation, the agency currently clears LDTs through its 510(k) pathway for medical devices. The legislative forebear of VALID was a bill called the Diagnostic Accuracy and Innovation Act (DAIA) that would have removed diagnostic tests from the definition of a medical device and thus outside the scope of the 510(k) pathway. After getting input from the lab and diagnostics industry, legislators submitted the DAIA draft to FDA for technical assistance. Instead of the usual technical edits, however, the FDA proposed an entirely new framework to overhaul the 510(k) premarket review program.

After the FDA’s scheme received a thumbs down from the industry, DAIA’s sponsors incorporated the FDA’s ideas, including pre-certification, into a discussion draft of a new bill called VALID introduced in December 2018. However, VALID went nowhere in 2019. So, now the lawmakers are reintroducing it.

What VALID Would Do

If enacted, VALID would create a new product category for diagnostic and lab tests, putting their review and approval under the FDA. It would also overhaul how the FDA reviews and approves diagnostic tests while giving labs greater flexibility in responding to public health emergencies.

Essentially, VALID creates a risk-based framework for IVCT regulation, with high-risk tests, like novel assays, required to go through premarket review; lower-risk tests could go to market after passing through technological certification. Specific features that VALID would implement:

  • Establishment of a technology certification program for lower-risk tests;
  • Requirement that high-risk tests undergo premarket review to verify analytical and clinical validity;
  • Authority of the FDA to require that any test undergo premarket review after providing the developer an opportunity to address issues identified by the agency; and
  • Creation of a new system to allow hospitals and labs to submit their tests electronically to the FDA for approval, a move that would speed up the approval process and increase the quality and reliability of the testing, according to the bill summary.

The law would also grandfather in existing LDTs being used clinically.

Lab Industry Reaction

In a press release American Clinical Laboratory Association President Julie Khani indicated that the organization will be reviewing VALID with members and engaging members on the Hill and the broader health care community. She noted: “Over the past several years, ACLA and our members have been actively working with stakeholders to advance meaningful comprehensive diagnostic reform for patients. As we’ve consistently stated, a modernized regulatory framework must ensure sustained innovation for patients and providers and support continued access to the laboratory tools necessary for the diagnosis, monitoring and treatment of disease.”

Specifically, noted Khani, ACLA has consistently pushed for three main priorities:

  1. Reform that recognizes diagnostics as separate and distinct services from medical devices, and that also distinguishes between LDTs and IVDs;
  2. Grandfather and transition policies that protect patient access to currently available lab tests; and
  3. A regulatory system that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.

However, she stated, in the short term ACLA and its member companies are focused on responding to the growing demand for COVID-19 testing capacity, and would be turning to closer review of the new version of VALID in the near future.

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