The U.S. FDA granted Roche Holding AG breakthrough device designation for the Elecsys pTau217 assay that it is developing with Eli Lilly and Co. The test will help with the earlier diagnosis of Alzheimer's disease as it will be able to identify pTau217, a phosphorylated fragment of the protein tau, which is a biomarker that can distinguish the disease from other neurodegenerative disorders.
Prenosis Inc. gained U.S. FDA de novo marketing authorization for an artificial intelligence-powered rapid diagnostic tool for sepsis, one of the most challenging and deadly conditions in hospitals and reported a distribution agreement with Roche Holding AG. Another pairing also made progress in developing a sepsis in vitro diagnostic this week, as Bosch Healthcare Solutions GmbH and Randox Laboratories Inc. joined forces and committed €150 million (US$159.63 million) to the effort.
Exact Sciences Corp., Seekin Inc. and Serum Detect Inc. presented encouraging results for the field of multicancer early detection at the American Association for Cancer Research annual meeting in San Diego April 6-10, but delays in coverage may slow further progress.
Australia’s Speedx Pty Ltd. is launching a new rapid polymerase chain reaction (qPCR) test for 14 different respiratory viruses in a single test that works on almost every commercial PCR platform in half the time and at a fraction of the cost of what its competitors charge.
At a recent meeting on “Research priorities for preventing and treating Alzheimer’s disease and related dementias” (ADRD), convened by the National Academies, one consensus priority on ADRD research was that there needs to be more of it at every stage. Several speakers presented stark numbers on the relative volume of research in cancer and neurodegeneration. Research output, measured in peer-reviewed papers, for dementia is estimated to be around 10,000 papers annually, compared to 150,000 for cancer, while AD clinical trials are also few and far between compared to cancer trials. This final installment of BioWorld’s series on Alzheimer’s explores some of the reasons for this discrepancy along with the latest advances and ongoing efforts to accelerate research and drug development in the field.
Carelight Ltd. reported seeking protection for a wearable real time opto-physiological monitoring system for monitoring heart rate, respiration rate, oxygen saturation, blood pressure, heart rate variability, pulse wave velocity, and body temperature.
The U.S. FDA posted two device warning letters in the first week of April 2024, including one each to Beckman Coulter Inc., of Brea, Calif., and Agena Bioscience Inc. of San Diego, the former of which was directed toward the Chaska, Minn., facility that manufactures the Beckman Coulter Dxl 9000 analyzer.
Artificial intelligence (AI) is steadily making inroads into the world of health care, and San Francisco-based Eko Health Inc. has taken up the AI call with a stethoscope developed in conjunction with the Mayo Clinic that can detect low ejection fraction of the heart.
Laboratory Corporation of America Holdings Inc. agreed to purchase select assets of Bioreference Health from Opko Health Inc. for $237.5 million in a deal slated to close in the second half of 2024. The transaction could be the start of a buying spree for the country’s second-largest independent laboratory testing service provider, as Labcorp management has laid out an acquisition strategy that focuses on higher-growth areas, particularly reproductive and women’s health.
In what represents its first patenting, Anjo.ai Inc seeks protection of systems for remote monitoring, early detection and notification for life-threatening allergic anaphylactic reactions using wearable sensors and artificial intelligence. The system can recognize an allergic reaction even before the visible symptoms appear.
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