FDA LDT Regulation Could Affect 60,000+ Tests

The U.S. Food and Drug Administration’s (FDA’s) proposed regulation of laboratory developed tests (LDTs) could affect 60,000 genetic tests, according to analysis by Tenn.-based IT firm NextGxDx. Depending on the ultimate classifications of risk, nearly 8,000 genetic tests could face premarket review requirements with a high-risk device designation. Accurate estimates of the number of tests currently on the market are important as the FDA finalizes its oversight plan, designs implementation strategies, and allocates adequate resources towards operationalizing for the new regulatory scheme.

Many have been trying to estimate the number of currently marketed genetic tests. The FDA and industry sources have publicly quoted that 11,000 laboratories are offering as many as 100,000 molecular LDTs in the United States. GeneTests.org, a wholly owned business unit of BioReference Laboratories, maintains that as of Feb. 25, 2016 there are 55,574 genetic tests available from 678 laboratories internationally. The National Institute of

Health’s Genetic Testing Registry, which requires test providers to voluntarily input test information, has records for 32,000 genetic tests including prenatal, somatic, and pharmacogenetic tests.

Since the vast majority of new molecular diagnostics have come to market under CLIA, the proposed regulations represent a significant shift. With the FDA indicating it will utilize a risk-based approach to regulation and prioritization, laboratories are assessing where their tests will fall along the spectrum.

As of Jan. 11, 2016, NextGxDx estimates that there are 60,482 genetic testing products on the market, with an additional eight to 10 tests entering the market daily. In 18 months from July 2014 to January 2016, the company’s databases show that 5,674 new testing products entered the market, with panel entrants growing 24 percent in that time period.

Using data from October 2015 (53,000 genetic testing products), NextGxDx analyzed tests under three different risk classification scenarios, recognizing the FDA’s stated intention to use expert advisory panels to guide decisions about risk status. The company’s bioinformatics specialists estimate that, depending on the definition of risk, anywhere from 1.12 percent to 14.43 percent of tests could fall under highrisk regulation, which translates to between 587 and 7,568 tests. One major variable in the different risk scenarios is whether the FDA includes the American College of Medical Genetics and Genomics’ 56 recommended genes to report incidental findings in its definition of high-risk tests. If the FDA does include these genes, NextGxDx says tests for these genes alone would involve: 121 laboratories, 331 clinical categories of tests, and 3,455 different testing products.

NextGxDx provides an online genetic testing marketplace that offers health care providers and hospitals the ability to compare up-to-date listings of all genetic tests from CLIA-certified laboratories, order tests online, and manage results and utilization electronically within the HIPAA-compliant portal.

“We see great value in data-driven stakeholder dialog throughout the regulatory process,” says Gillian Hooker, Ph.D., vice president of clinical development at NextGxDx. “We provide an innovative way to track parts of the market and bring transparency to everyone. We play a role in informing multiple stakeholders.”

Once laboratories understand the risk profile of their tests, Hooker says laboratories are waiting to see what evidentiary standards the FDA requires.

“If there are high evidentiary standards, this could be the most costly part of getting a test approved,” says Hooker. She adds that the next step in this analysis is incorporating cost data to estimate the potential financial impact of complying with the proposed regulations on laboratories.

Takeaway: As the industry awaits the FDA’s finalization of LDT regulation criteria, NextGxDx is helping to inform estimates of how many LDTs could fall under the FDA’s purview and in what risk category.