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The Food and Drug Administration is stepping up its plans to regulate all medical laboratory testing. And in a new report issued this week, the agency outlined 20 examples of tests performed by a single laboratory — so-called laboratory-developed tests, or LDTs, which currently fall under the jurisdiction of the Centers for Medicare & Medicaid Services, not the FDA — that may have harmed patients because they weren’t fully vetted and validated.

“FDA oversight would help ensure that tests are supported by rigorous evidence, that patients and health care providers can have confidence in the test results, and that LDTs have more scientifically accurate product labeling,” Dr. Peter Lurie, the FDA’s associate commissioner for public health strategy and analysis, wrote in a blog post announcing the new report.


The publication seems to have been timed to coincide with a hearing in the US House on Tuesday, where lawmakers sought to better understand the role of the FDA and CMS in regulating these kinds of lab tests, and what changes, if any, may be necessary going forward. Legislators are also considering draft legislation to create a new regulatory framework for such tests.

Currently, the FDA generally reviews test systems or kits that are sold by manufacturers for use in multiple hospitals, doctor’s offices, or other kinds of laboratories. These fall under the agency’s purview because they are classified as medical devices. However, lab tests performed in a single, centralized location are not usually subject to FDA scrutiny so long as the laboratories themselves meet standards dictated by CMS.

The FDA isn’t happy about the status quo. And in recent years, the agency has upped its scrutiny of LDTs that seem to cross the regulatory line into device territory. For many of these tests the underlying technology has grown increasingly complex, with more potential risk to patients, and many are now being marketed directly to consumers.


Last year, the FDA released draft guidance outlining how it plans to handle LDTs, while also laying out reporting requirements for labs that offer these tests.

“FDA oversight would help ensure that tests are supported by rigorous evidence.”

Dr. Peter Lurie, FDA

With its new report, the FDA seems to be making the case for why it needs more powers of enforcement. In some instances, the agency found that consumers were incorrectly told they had illnesses, which caused “unnecessary distress and resulting in unneeded treatment.” In others, the tests either failed to detect disease, or had “no relevance” to the intended use.

These examples may help those who are new to the issue better understand the FDA’s rationale. But, according to Jeffrey Gibbs, director at the law firm Hyman, Phelps, & McNamara, they’re “not going to sway people who have strong views” one way or the other.

Myriad Genetics’ Prolaris test for prostate cancer was one of the products considered by the FDA. In its report, the agency said that, while physicians are using Prolaris to make patient management decisions, there has been no study conducted to assess whether decisions based on Prolaris test results were “clinically appropriate.”

In a statement to STAT, Myriad said that Prolaris is a “rigorously validated test,” which has been studied in more than 5,000 patients and supported by more than 10 peer-reviewed studies. It added that the FDA’s report is not a scientific review of the test, but instead relies on “secondary sources” including a 2013 editorial, which called for clinical validation studies that have since been conducted and published.

“Along with our industry counterparts, Myriad is working with members of Congress, US Food and Drug Administration, industry groups, and other stakeholders to support proposals for regulations that will guarantee patients timely access to rigorously validated molecular diagnostics,” Myriad said in its statement. The Salt Lake City-based company also makes the test that Angelina Jolie used to discover she carries a gene variant that confers a heightened risk for breast and ovarian cancer.

In recent months, the FDA has also singled out Theranos, the highly-valued biotech company, over concerns about blood collection vials, and Pathway Genomics, a personalized medical diagnostics firm, about a cancer screening test.

Many of these companies and clinical laboratories across the United States continue to oppose what they see as FDA overreach. In a letter sent last year to the Obama Administration, 23 laboratory directors argued that many LDTs critical to public health — including DNA sequencing assays, and tests for rare diseases — would never generate enough revenues to justify the costs associated with getting FDA approval. And if the regulations changed, the labs would be forced to stop offering them.

“Patients served by these tests would be left with no testing options,” the letter said.