The U.S. FDA’s pending final rule for regulation of lab-developed tests has proven unusually controversial even for the FDA, but Rep. Anna Eshoo (D-Calif.) stated in a March 21 hearing that congressional inaction has left the agency in an uncomfortable spot.
An advocate general (AG) for the E.U. Court of Justice did not mince words in calling out the European Commission for its “very significant extension of the scope of the Merger Regulation and of the commission’s jurisdiction” in reviewing Illumina Inc.’s $7.1 billion acquisition of Grail LLC.
Laboratory Corporation of America Holdings expanded its blood biomarker test portfolio for Alzheimer’s disease, making its pTau217 test available by prescription in the U.S. as well as for research globally. The standalone test can also be used in monitoring patients undergoing treatment for the neurodegenerative disease.
Researchers from the University of Stellenbosch in South Africa are seeking protection for a simple and user-friendly point-of-care device for diagnosing tuberculosis. Their electrochemical lateral flow device merges lateral flow device technology and electrochemical device technology by using porous electrodes that are capable of transporting electrolytic liquid and fluid sample.
In what represents their first patenting, a researcher from the University of California is seeking protection for non-invasive methods of brain monitoring that use electroencephalography (EEG) to detect new or worsening brain injury in pediatric patients.
Roche AG debuted a new continuous glucose monitor (CGM) at the Advanced Technologies & Treatments for Diabetes conference in Florence, Italy, last week, but how appealing users will find it remains unclear – as is the market opportunity given the entrenched position of Abbott Laboratories and Dexcom Inc.
While members of the U.S. FDA’s Imaging Drugs Advisory Committee weren’t blown away March 5 by the trial performance of Lumicell Inc.’s Lumisight (pegulicianine) in helping breast cancer patients avoid second surgeries due to negative margins following a lumpectomy, they voted 16-2, with one abstention, that the benefits of the imaging drug outweigh its risks, even though those benefits are incremental.
The March 5 meeting of the U.S. FDA’s Medical Imaging Drugs Advisory Committee could be the gateway to the first approved intraoperative technology for use in breast cancer that directly examines the lumpectomy cavity for residual cancer.
Osang Healthcare Co. Ltd. is attempting a second listing on the Kosdaq market with an IPO, planned sometime in March, to fund the company’s growth beyond the COVID-19 pandemic.
The U.S. National Institutes of Health reported the launch of a network for clinical trials that will examine the utility of cancer screening tools, which will start with a pilot study of multi-cancer detection (MCD) tests.