FDA to regulate lab-developed tests, citing safety issues raised by journalists

Journalists will have new angles to pursue as the FDA begins to regulate laboratory-developed tests (LDTs), clinical analyses of human blood or tissue meant to detect diseases, conditions or infections. LDTs have sparked many news stories about the harms of poorly performing tests.

These articles contributed to a "growing body of evidence" that inaccurate LDTs threaten public health, Jeff Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a media call in April.

The agency plans to phase in its new rule over four years, ultimately subjecting LDTs developed in CLIA-certified laboratories to the same safeguards as traditional manufacturers.

But the advent of regulation could invite industry pushback or even an entirely new regulatory scheme from Congress, according to some journalists who follow the issue.

"The LDT rule is historic from a device regulatory perspective, as FDA, industry, and labs have been wrestling with this ambiguity about diagnostics oversight for decades," David Filmore, executive editor of MedTech Strategist Market Pathways, said via email.

LDTs have been allowed to proliferate under a 48-year-old FDA policy to waive regulatory requirements such premarket review and quality oversight for tests that are designed, manufactured and tested in the same lab.

As the testing market expanded, low-quality LDTs caused patients to be inappropriately treated for conditions such as heart disease and cancer and receive wrong diagnoses for rare diseases, autism and Alzheimer's Disease, according to federal officials. Debacles with Covid-19 testing showed the situation has worsened, they added.

How news coverage contributed

Federal officials referenced a Medscape article written by Donavyn Coffey that described false results from a multi-cancer detection test that was given to first responders in Arizona.

Many journalists have drawn attention to the fact that physicians and patients often have no way to tell whether a LDT is valid.

A few examples:

• In 2014, Beth Daley won an AHCJ Award for Excellence in Health Care Journalism for exposing harms such as companies overselling the accuracy of prenatal tests. You can read her blog post for AHCJ here.
• In 2015, Thomas Burton reported for The Wall Street Journal on a lab-industry trade group's expensive lobbying effort against regulation.
• Also in 2015, Arielle DuHaime-Ross wrote in The Verge about labs that sold cancer tests without rigorous evidence that they work.
• In 2021, STAT News' Eric Boodman investigated EpicGenetics, which exaggerated the accuracy of its fibromyalgia test.
• In 2022, teams at the New York Timesand ProPublica ran separate investigations on inaccurate prenatal screening tests.

What to follow

Daley, who is now executive editor of The Conversation, said journalists should continue to examine whether LDTs are backed by peer-reviewed studies and how frequently they produce false results.

The sheer number of LDTs - which the FDA estimates to be 40,000 to 160,000 - could hinder enforcement given the agency's limited resources, according to the advocacy group Center for Science in the Public Interest.

The FDA said it will exercise "limited enforcement discretion" for tests that are already on the market and tests developed by a health system lab to meet its own patients' unmet needs. Such tests will be exempt from premarket review and most quality system requirements although labs must register their tests and submit labeling information.

Tests approved by the New York State's Clinical Laboratory Evaluation Program, which regulates testing of specimens that originate in New York, also will get a pass.

During the media call, Shuren said the final rule is meant to "strike the right balance" of protecting patients while avoiding interruptions in access. He added that the FDA can take action if it identifies a problematic test.

Daley noted potential for lawsuits and pressure on Congress to intervene as well as questions about how regulation will affect the diagnosis of rare disease.

"This is the first step in what will be a very long process to find a middle ground that allows nimble development of tests, but with the proper oversight that claims are based on evidence," she said.

Filmore, whose focus is product development, said he'll be watching to see whether the rule "sets the table for a new regulatory system for all diagnostics" enacted by Congress.

Other angles he said he'll be following:

• How new documentation and safety reporting requirements affect the lab industry.
• Whether the FDA will need to reallocate resources in order to bring LDTs into its day-to-day oversight.
• Whether companies developing new tests will establish themselves as traditional manufacturers rather than as CLIA labs, which was a common strategy to avoid FDA review.

"LDTs with all the associated jargon can seem dry," Daley said. But she added that journalists "should question the process every step of the way. Billions of dollars are on the line."