How Trump could upend a plan to police lab tests

• After years of debate, regulators last spring finalized a policy to treat the tests like medical devices, citing the risks to patients from potentially flawed or inaccurate tests.
• A rollback would be a win for testing giants like Quest Diagnostics and Labcorp, as well as academic medical centers, which frequently make their own lab tests.
• It's one of dozens of Biden health policies that the new administration could move to scrap.

Where it stands: Labs have until May 6 to comply with the first phase of the plan and set up a system to report adverse events with tests for COVID-19, cancer genes, heart disease and rare medical conditions, among other things.

• But testing interests are pressing the incoming administration to clarify as soon as possible that it doesn't plan to enforce the policy.
• Such an announcement "would demonstrate the new administration's commitment to a responsible regulatory approach and allow laboratories to focus fully on their highest priority — serving patients," the American Clinical Laboratory Association and other trade groups wrote to the Trump transition team in November.

Flashback: Regulatory experts see the Trump administration as likely to be sympathetic to labs' requests, in part because Health and Human Services blocked the Food and Drug Administration from regulating lab-developed tests during Trump's first term.

• "I would be surprised at this point if the administration, once they're in office, looks at this rule and says, 'Nothing to do here. We're just going to stay hands off,' just given the level of interest and the different levers that they have to change it," said Stephen Holland, senior counsel at Crowell & Moring.

The Trump administration would have to conduct its own lengthy rulemaking process to formally rescind the regulation. But it could opt to delay or not enforce the policy without taking it off the books, Holland said.

• Courts could also scuttle the initiative. A lawsuit from ACLA and the Association of Molecular Pathology charges Congress never granted the FDA authority to regulate the professional testing services.
• Trump officials haven't spoken publicly about the lab-developed test regulations and didn't respond to questions from Axios on their plans for the rule.

The intrigue: The industry also hopes to find allies among the Trump administration's wellness-focused health officials.

• Lab-developed tests could be integral to the so-called Make America Healthy Again movement, Susan Van Meter, president of ACLA, told Axios.

• "Lab tests can give you that sort of baseline understanding about how you are doing … where there are diseases or conditions that can be prevented, as we all know they can be, with nutritional changes, changes in behavior and the like," she said.

The other side: Patient advocates worry that reversing or not enforcing FDA oversight of the tests will allow inaccurate test results and misleading marketing of tests to proliferate at a time when they're only becoming more integral to patient care.

• FDA commissioner Robert Califf has said 70% of medical decisions depend on laboratory test results and that the ability to ship specimens across the country has significantly expanded testing in recent decades.
• "The great gaping hole in the FDA regulatory approach … had been covered up, only to have the entire edifice of regulation threatened again for multiple quarters as a result of the election," said Peter Lurie, president of the Center for Science in the Public Interest.

The testing industry argues that Congress should legislate any regulation changes for lab tests. But that's unlikely in the near term, with lawmakers focused on taxes, immigration and energy policies.

Zoom out: Analysts foresee the broader diagnostics industry going gangbusters in the next decade, Axios Pro's Erin Brodwin wrote last month.

• COVID spurred interest in medical testing innovations. Investors in cancer diagnosis, precision medicine and at-home testing could see big returns within 10 years, a report from Pitchbook predicts.

The bottom line: Even if the FDA plan goes forward, it will allow many existing tests to be grandfathered in without additional oversight.