FDA clears blood test measuring Lp(a) in molar units
March 2025—The Roche Tina-quant Lipoprotein (a) Gen.2 Molarity assay received 510(k) clearance from the Food and Drug Administration. It is the first 510(k)-cleared test of its kind available in the U.S. to measure lipoprotein(a) in nanomoles per liter. It will be broadly available on Cobas c analyzers.
Lp(a) can vary in size and has no single, defined molecular weight. For this reason, Roche says, there is a consensus in the scientific community that Lp(a) levels should be measured in terms of the number of particles per liter of blood (nmol/L), rather than mass units (mg/dL), and that any conversion between mass and molar units is generally imprecise and unreliable. By using molar units, laboratory professionals and clinicians know the Lp(a) measurements reflect the number of particles rather than a difference in particle size.
Pam Taub, MD, of the Department of Cardiovascular Medicine at the University of California San Diego School of Medicine, said in a news release, “With the opportunity to now consistently and accurately measure Lp(a) in particle concentration units, and anticipated Lp(a)-lowering treatments coming to market, clinicians have an opportunity to help their patients understand and potentially lower their cardiovascular risk.”
In May 2024, as part of a separate FDA submission, the Roche Tina-quant Lp(a) RxDx assay, which is intended to support the selection of patients who may benefit from an innovative Lp(a)-lowering therapy, received a breakthrough device
designation from the FDA. This is different from the Tina-quant Lipo-protein(a) Gen.2 Molarity assay cleared in January this year.
Enhertu approved for HER2-low, -ultralow metastatic breast cancer
Enhertu (trastuzumab deruxtecan) has been approved in the U.S. for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer that has progressed on one or more endocrine therapies in the metastatic setting.
The Food and Drug Administration granted approval after the HER2-directed antibody drug conjugate, from AstraZeneca and Daiichi Sankyo, had secured priority review and breakthrough therapy designation. Approval was based on the results of the DESTINY-Breast06 phase three trial.
In the trial, Enhertu showed a 36 percent reduction in the risk of disease progression or death versus chemotherapy in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer. A median progression-free survival of 13.2 months was seen in patients randomized to Enhertu compared with 8.1 months in those randomized to chemotherapy.
The rise of private equity in health care
The increase in private equity investments in health care might be thought to be primarily a U.S. issue, given how the U.S. health care system is organized and its reliance on private funding, but the authors of a Perspective published last month in the New England Journal of Medicine say other high-income countries have seen the growth of such investments (Singh Y, et al. N Engl J Med. 2025;392[7]:627–629).
“Countries that rely more on price regulation and public financing or ownership might be expected to be less vulnerable than the United States to corporate influences in health care,” they write. “But private equity firms have entered health care systems in various other high-income countries, drawn to profit opportunities in private sectors in each system.”
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They say these firms have emerged in countries that have a national health service, where health care systems are typically funded by taxes and the regulation and provision of services are largely the government’s purview (the U.K. and Sweden, for example); countries with national health insurance systems that rely on private provision of services by for-profit actors (Australia and Canada, for example); and countries with social insurance models (such as Germany and France).
The authors, of Brown University’s School of Public Health, write, “There is a pressing need for research into the growing corporatization of health care, including an international examination of the emergence of private equity investments in specific health care sectors, similarities and differences in the strategies used by firms operating in and outside the United States, and the effectiveness of various regulatory responses to the rise of private equity, among other issues.” The authors add that funders and organizations like the National Institutes of Health and the European Commission could support the research.