Megan Robertson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in 360Dx, in “2025 Clinical Lab Space Bookended by Demise of FDA's LDT Rule, Abbott's $23B Exact Sciences Deal,” by Adam Bonislawski. (Read the full version – subscription required.)
Following is an excerpt:
As 2024 closed, the US Food and Drug Administration had - much to the chagrin of clinical labs - at last made good on its decades-long promise to regulate laboratory- developed tests (LDTs), formally bringing these tests under agency oversight.
Three months into 2025, however, the tables had turned, as a federal court vacated the FDA's LDT rule in a decision that for many lab stakeholders no doubt ranked among the year's highlights. …
Megan Robertson, an attorney with Epstein Becker Green, noted […] that with the rise of digital health and DTC products, the FDA is paying closer attention to companies in that space, particularly with regard to their use of Al and other algorithms to provide users with interpretations of lab results and other data.
"The line between a wellness claim and a clinical claim that would be regulated by the agency is definitely getting a little blurrier," she said. She noted that while she has not seen direct enforcement actions from the agency, she has seen an increase in private communications with firms.
