FDA Suggests Data Sharing for LDT Woes

With the Food and Drug Administration (FDA) focused on clinical validity in its proposed regulation of laboratory-developed tests (LDT), many in the lab community have observed that accruing the necessary data is a major challenge. At least in the case of molecular genetic testing, FDA officials are suggesting that more data sharing among laboratories would alleviate the problem. Were these data silos broken up, new evidence might organically support the robust clinical validity for testing that FDA is seeking, according to Jeffrey Shuren, MD, JD, director of FDA's Center for Devices and Radiological Health.

Speaking at the American Clinical Laboratory Association (ACLA) annual meeting in March, Shuren emphasized that much of the data that would support validation of new or existing tests already exists, but institutions are keeping it confidential. “If only we could free that data up and move to a place where we are sharing and aggregating that information, there would be lots of things that we could understand—and have significantly lower costs than we do today,” he said.

FDA also envisions more collaboration around developing standards for analytical and clinical validity, according to Shuren. He held up the model FDA is pursuing for regulating next-generation sequencing tests, and suggested that with the right model of standards for clinical validity and clinical claims—and open databases that FDA can review and certify—some tests might not require prior FDA review as high–risk tests. “Then you have the opportunity for [clinical] claims to evolve in line with the evolution of the science,” he said.

In the meantime, it appears that the final guidance on LDTs may come later in the year. Asked about previous comments in which he predicted the final guidance could come out in early 2016, Shuren responded: “Here are the realities: there is a current administration, and that administration is here until early calendar year 2017.”

Coalition Pursues Federal Funding for Harmonization

AACC, joined by other laboratory associations, in vitro diagnostics companies, and clinical laboratories, is asking Congress to set aside funds in 2017 appropriations bills to harmonize laboratory testing. For those tests without a gold standard for reporting comparable results, harmonization allows for uniform results regardless of which assay or instrument is used.

The group wrote to senators and members of the House of Representatives, requesting $9.2 million for the Centers for Disease Control and Prevention (CDC) to carry out this work.

“The undersigned organizations believe that every patient should have access to dependable and accurate clinical laboratory test results and that those test results should be harmonized,” the letter said. “The CDC has already done incredible work harmonizing the results for a limited number of tests, but we believe with additional funding CDC could expand its efforts—benefiting clinicians and patients alike, and contributing to overall efficiencies in public health and healthcare.”

Harmonized test results are critical if clinical guidelines are to actually improve care, the letter emphasizes. Harmonized tests also can prevent unnecessary, expensive follow-up testing caused by misinterpreted test results.

AACC succeeded in getting report language included in the Consolidated and Furthering Continuing Appropriations Act of 2015. This statement urges CDC to work with the private sector in accomplishing greater harmonization.