Senate Holds Hearing on Lab-Developed Tests

Posted in IVD by Nancy Crotti on September 20, 2016

Would FDA regulation of laboratory-developed tests add cost and delays or prevent potential danger to patients? A Senate committee took on the topic this week.

Nancy Crotti

Who should be regulating laboratory-developed tests (LDTs)? Currently, that’s the purview of CMS via the Clinical Laboratory Improvement Amendments (CLIA), through which the agency inspects and licenses commercial and clinical laboratories. In 2014, FDA developed draft guidance for regulating LDTs as medical devices.

Two years later, the debate rages on, as technology speeds ahead and the demand for precision medicine heats up. The U.S. Senate Health, Education, Labor and Pensions Committee took on the topic this week.

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President Obama is on board. His Precision Medicine Initiative is intended to help boost research on new cancer treatments and genomic-based treatments. Last February’s Precision Medicine Summit highlighted the efforts of testing firm Color Genomics to make free breast and ovarian cancer tests available to at-risk patients who cannot otherwise afford them.

Laboratory scientists say FDA needn’t duplicate CLIA’s efforts and that an additional level of regulation would not only be costly, but could harm patient health by delaying useful tests. Manufacturers of test kits sold to laboratories, hospitals, and clinics go through the expensive and often prolonged FDA regulation process, and generally speaking, would like laboratories that develop tests for their own use to do the same.

The question also remains whether stronger regulation of tests developed by now disgraced blood testing company Theranos would have prevented possible danger to patients and the company’s downfall.

More than 60,000 LDTs are available to Americans today, regulated by CMS through CLIA, noted committee chair Senator Lamar Alexander (R-TN). Memorial Sloan Kettering Cancer Center’s molecular diagnostics laboratories perform approximately 350 LDTs, including genomic sequencing tests that characterize each patient’s cancer, testified David Klimstra, MD, chairman of the the pathology department at the New York City hospital.

The laboratory’s MSK-IMPACT assay analyzes 468 cancer-related genes and has been used to sequence nearly 12,000 cancers, Klimstra added. CLIA and the state of New York both regulate those LDTs. Adding FDA regulation would be “duplicative and unnecessary,” and so costly that it would force the center’s laboratory to close, Klimstra said.

An industry representative testified that regulatory requirements that differ depending upon the type of entity that develops the test yield different standards for accuracy and reliability, and other discrepancies between the types of oversight. The level of oversight should depend on the risk level to patients, said Brad Spring, vice president of regulatory affairs and compliance for Becton Dickinson.

Spring also called for clear jurisdiction between FDA, CMS, and individual states, along with expedited regulatory pathways for tests that serve unmet needs.

Cancer policy organization Friends of Cancer Research agreed with industry representatives that all diagnostic tests should be subject to the same regulatory requirements. FDA should work with the diagnostic industry to characterize the variability between LDTs and manufacturers’ test kits, added Friends’ president and CEO Jeff Allen.

Allen suggested that advanced genomic screening have its own regulatory pathway.  “The future of precision medicine and the health and lives of patients depends on the accuracy of these tests,” he said.

“An inadvertent outcome of the FDA review process is to delay or make necessary testing unavailable to patients, as well as to increase cost, neither of which are good for patient care,” argued Karen Kaul, MD, chair of the Department Of Pathology and Laboratory Medicine at the University of Chicago’s  North Shore University Health System.

Tests that go through the FDA regulatory process “do not keep up with the standard of care as dictated by nationally accepted (National Comprehensive Cancer Network) guidelines, and are essentially frozen in time at the time of FDA approval,” Kaul added.

Adding a level of premarket evaluation to the current CLIA process would be most useful and least onerous for laboratories, she said.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of Martin Falbisoner - Own work, CC BY-SA 3.0,]