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Dx industry is cautious, wary and diplomatic in the face of FDA's push to regulate LDTs

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The FDA's decision to pursue broad, risk-based regulatory oversight for genetic and other laboratory-developed tests (LDTs) is drawing cautious, diplomatic and hopeful responses from industry.

Reading between the lines of the range of statements issued after the U.S. Food and Drug Administration's announcement of pending draft guidance suggests there will be plenty of pushback and industry lobbying before any final regulations are put in place.

The Association for Molecular Pathology (AMP) insisted that these tests already have sufficient oversight by way of the Centers for Medicare & Medicaid Services' Clinical Laboratory Improvement Amendments (CLIA) program, which doesn't require rigorous and lengthy FDA premarket review. Regulators want to begin using the PMA process for certain higher risk tests and expand that oversight even further over time. But the AMP, in its statement, expressed concern about a move toward "over-regulation or inappropriate regulation" that could hurt patient care and access to vital tests.

Similarly, the American Clinical Laboratory Association (ACLA) issued remarks supporting the CLIA regulatory system, expressing concern that more regulation could "stifle diagnostic innovation and ultimately jeopardize patient access to timely and effective treatments."

Myriad Genetics ($MYGN) is one of the more influential companies as far as lab-developed genetic tests, and so tougher regulations could have a huge impact on it and its rivals. As Forbes noted, the company has been a pioneer with its breast and ovarian cancer predictive tests that look for BRCA1 and BRCA2 gene mutations that raise risks for the diseases. A U.S. Supreme Court ruling last summer invalidated some of its related patents, opening the door to competition. But Myriad still has a dominant share of the predictive cancer-testing market and issued a cautiously optimistic statement in the wake of the FDA's guidance announcement.

Myriad said it will review the FDA's draft guidance on how it would change the approval process for LDTs. The company added that it "looks forward to collaborating with policymakers and stakeholders to provide input and focus on the future" of how LDTs are regulated.

Interestingly, Myriad also made the point that it has staked out rigorous quality control on its own, but that patients also deserve to know that other LDTs have been developed according to the same tough standards.

"Regardless of the regulatory framework, Myriad has a strong track record of scientific excellence that includes conducting numerous clinical studies in support of the analytical and clinical validity claims of our diagnostic tests," the Utah-based company said. "We believe it is appropriate for patients to know that all LDTs have been developed with this amount of rigor. These studies continue even after our products are launched to further evaluate important new medical benefits for patients, while developing new scientific information about their safety and effectiveness. In all of our studies, Myriad monitors the results of its clinical testing and communicates those results to the medical and scientific communities."

Qiagen CEO Peer Schatz

Part of the FDA's push for broader regulatory reach over diagnostic testing is new guidance to govern the approval or clearance of companion diagnostic genetic tests, which help doctors choose a cancer treatment that will produce the best patient response. Qiagen ($QGEN) is expanding in this space, with two FDA-approved tests that pair with three different drugs that treat colorectal and lung cancers. In a statement, Qiagen CEO Peer Schatz said that the FDA's move to toughen its regulatory policies is a smart decision.

"We applaud these important steps by the FDA to ensure that patients are getting the most accurate, consistent and reliable results from companion diagnostic tests," Schatz said. "These tests have quickly proven their value in improving outcomes for cancer patients, providing valuable molecular information to guide treatment decisions and reducing the 'trial-and-error' treatment approach. We continue to work with the FDA and regulatory agencies around the world on developing regulatory pathways for companion diagnostics, and this is especially important as we move toward offering multibiomarker diagnostics enabled by various technologies."

AdvaMed's diagnostics arm (AdvaMedDx), meanwhile, issued a statement that "welcomes" the FDA's draft guidance on LDTs and stated membership support for a "modernized and flexible" approach to diagnostics regulatory review. Additionally, the group, like many other players in the regulatory debate to come, said it would offer "substantive" comments on the draft guidance, once it is published, to ensure that the measure "supports patient access to safe and effective tests."

- read the AMP's statement
- here's Myriad's release
- see the ACLA statement
- and here's AdvaMedDx's post

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