The U.S. FDA’s Center for Biologics Evaluation and Research posted four warning letters to makers of HIV sample collection kits, an example of a shift in FDA enforcement in the IVD space that is still allowed after a historical loss in court.
Rhythm Biosciences Ltd. launched a new genetype colorectal cancer risk assessment clinical test that incorporates clinical and lifestyle risk factors alongside its established 140-SNP polygenic risk score to identify people at elevated risk of colorectal cancer. The test supports more targeted screening and complements Melbourne-based Rhythm’s Colostat blood-based CRC detection test, which debuted in Australia in December 2025.
The U.S. FDA’s final rule for regulation of lab-developed tests was destined to be controversial at best and exceptionally susceptible to legal challenge according to more than one legal opinion. The inevitable legal challenge succeeded wildly in a decision rendered in district court in March 2025, marking one of the rare instances in which the courts thwarted FDA rulemaking and thus is easily the regulatory story of the year for 2025. Attempts to regulate AI in the U.S. and Europe also dominated the regulatory landscape.
Prognomiq Inc. reported the launch of its Provue Lung, a novel blood-based laboratory developed test designed to help improve detection of lung cancer at its earliest, most treatable stages.
The U.S. FDA declined to appeal the outcome of a lawsuit eviscerating the agency’s final rule for regulation of lab-developed tests despite a 60-day window to do so.
The U.S. FDA famously lost a lawsuit over its final rule for regulation of lab-developed tests (LDTs), but Jeff Shapiro of King & Spalding told BioWorld that the implications of this decision go beyond FDA regulation of clinical lab operations.
The routine use of software to interpret the results of lab-developed tests (LDTs) leaves clinical labs in a complicated spot in 2025 thanks in no small part to an ongoing lawsuit over the U.S. FDA’s final rule for LDTs.
Harmonized regulations for laboratory-developed tests (LDTs) across Asia Pacific are sorely needed at a time when LDTs continue to play a critical role in addressing unmet needs in the region, according to a recent whitepaper developed by APACMed.
2024 was a critical year for the FDA’s Center for Devices and Radiological Health and included a smooth transition in leadership, but it was not without controversy. The agency triggered not one but two lawsuits over the final rule for regulation of lab-developed tests, a problem that promises to distract the agency throughout 2025 and potentially beyond.
The U.S. FDA’s authority was challenged on a number of occasions over the past few decades, but the rate is likely to pick up as the U.S. Supreme Court ruled recently that the agency cannot take judicial deference for granted any longer. Chad Landmon of the D.C. office of Polsinelli told BioWorld that future litigation against the FDA may extend even to sub-regulatory guidance thanks to the outcome in the case of Loper Bright – a scenario in which industry might carve out a few significant wins in the coming year.
