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Bloomberg – Risky Lab-Developed Medical Tests Back in FDA Crosshair

Bloomberg – Risky Lab-Developed Medical Tests Back in FDA Crosshair

A potential resolution to a lingering debate on how the government should oversee laboratory-developed diagnostic tests would focus the FDA’s attention on the more cutting-edge and riskier screening tools.

At issue is a disagreement between device companies and clinical laboratory groups on what constitutes appropriate federal oversight of laboratory-developed test (LDTs), which are developed in a single laboratory, compared to the same type of diagnostics made by device companies.

Scott Gottlieb, commissioner of the Food and Drug Administration, unveiled Sept. 13 a proposal for how his agency could regulate in vitro diagnostic tests, or tests on bodily samples, that would tier oversight based on risk.

“The FDA has an obligation to regulate diagnostics, and I believe we should do so in a way that advances opportunities for innovation, while maximizing protections for patients,” Gottlieb said during a Sept. 13 forum by Friends of Cancer Research.

The FDA’s approach for regulating in vitro diagnostics “needs to be the same whether the test developer is a traditional manufacturer or a clinical laboratory,” he said.

Legislation in the Works

The FDA’s proposed framework will inform legislation that’s in the works by Reps. Larry Bucshon (R-Ind.) and Diana DeGette (D-Colo.) to update regulations for diagnostic tests. Gottlieb’s comments revealed the technical amendments the FDA provided to the lawmakers, who are aiming to introduce a House bill this fall, a House staffer told Bloomberg Law.

The FDA has historically enforced its device regulations on diagnostics developed by device companies but left LDTs alone. Laboratories must follow standards under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services.

The FDA sought to regulate LDTs first in 2014. Device makers embraced the proposal, and clinical lab groups decried it as double regulation by the FDA and CMS. The FDA ultimately pulled its proposal just before President Donald Trump took office, and Gottlieb said there needs to be a legislative solution.

Gottlieb aimed to position the new framework as a flexible, modern approach of balancing innovation with protecting patient safety, but reactions from laboratory and device groups indicate the dynamic from 2014 continues to play out.

“We share the goals of a modern, flexible approach to the oversight of clinical laboratory diagnostics. However, a number of the written proposals FDA has provided to Congress are cause for genuine concern, and we believe would in fact slow innovation and limit patient access to innovative and high quality tests,” Julie Khani, president of the American Clinical Laboratory Association (ACLA), told Bloomberg Law in a Sept. 13 statement.

AdvaMedDx, the trade association for diagnostics companies like Abbott Laboratories, Medtronic Inc., and Johnson & Johnson, hailed Gottlieb’s announcement as “a significant, positive step toward enacting legislation modernizing regulation of all diagnostics, including Laboratory Developed Tests.”

Gottlieb acknowledged “there will be difficult policy decisions to make and tradeoffs on any path to legislation. We know that the FDA must be flexible and open minded to new approaches that best meet the needs of patients so that patients can have confidence in the results and the treatment that comes from it.”

Tests Are More Advanced, Riskier

The FDA’s decision not to regulate LDTs stem from regulations that came out in 1976, when have since advanced from simple tests, such as tests to screen for blood glucose levels, to more complex ones that use the DNA in blood to detect, track, and treat cancer. The FDA had concerns about the reliability and accuracy of LDTs, such as the chance of a false positive reading for ovarian cancer prompting a woman to remove her ovaries unnecessarily.

These advanced diagnostic tests that can screen entire person’s genome are the linchpin to precision medicine—which takes into account individual differences in lifestyle, environment, and genes—because the results of these screening tools are what doctors will use to make targeted treatment decisions.

However, the ACLA has countered CLIA’s robust requirements ensure the quality of LDTs.

The proposal the FDA put forth to lawmakers would make about 10 percent of diagnostic tests subject to a high level of FDA scrutiny that’s generally restricted to the riskiest of devices. About 40 percent of laboratories likely would be eligible for a precertification program that means the agency wouldn’t review individual tests, and more than 50 percent of tests would be exempt from premarket review, Gottlieb said.

The proposal would grandfather most LDTs currently being offered to patients, including low-risk and low-volume diagnostics, Gottlieb said. “All in vitro clinical tests would fall under a unified set of requirements that would also exempt from premarket review many categories of new or subsequently-modified tests.”

Pre-Certification Program

The FDA also would offer a precertification program to laboratories to allow for review of a single test, and the validation procedures associated with that test, to serve as an umbrella for clearance of a suite of related tests.

Gottlieb said this program would enable the FDA to focus the agency’s resources and expertise where it’s most needed, including tests that are higher-risk and novel, and many companion diagnostics and home-use tests. There would also be a requirement to submit data once these diagnostics are on the market to ensure their safety.

“This is the path we should be on for our most advanced technologies that have the greatest potential to help us treat and cure disease,” he said.


Reproduced with permission. Published Sept. 13, 2018. Copyright 2018 by The Bureau of National Affairs, Inc. (800-372-1033) <;