Quest Diagnostics Inc. expanded its Alzheimer’s disease (AD) portfolio with a blood-based biomarker test for phosphorylated tau 217 (pTau217). The test joins the company’s plasma tests for p-tau181, beta-amyloid 42/40 ratio and ApoE genetic risk as well as several cerebrospinal fluid tests for Alzheimer’s.

The Netherlands-based research company Stichting imec Nederland filed for protection of a smart toilet seat for the non-invasive measurement of physiological parameters, and especially for detecting a bowel movement and/or urination, and for characterizing excrement or feces in terms of a firmness level.

Researchers from the U.K. reported seeking protection for a device and method that combines electromyography (EMG) and Raman spectroscopy to improve the diagnostic pathway for patients with neuromuscular disorders, and that may be used as a minimally invasive bedside test of muscle health.

While the U.S. FDA’s final rule for regulation of lab-developed tests (LDTs) has yet to emerge, there is some reason to expect the rule will be met with litigation from clinical lab associations. The FDA’s Jeff Shuren said in remarks to this year’s meeting of the Medical Device Manufacturers Association that there is a legitimate problem with the accuracy of many LDTs, adding that while stakeholders are at liberty to question the FDA’s rulemaking, the agency’s experience in this area indicates that the question of LDT reliability is not up for debate.

The U.S. FDA granted Scopio Labs Ltd. de novo clearance for its artificial intelligence (AI)-powered software which analyzes bone marrow. Scopio’s Full-Field Bone Marrow Aspirate (FF-BMA) system aims to improve patient care by standardizing bone marrow aspirate analysis and elevating diagnostic precision.

In what represents its first patenting, Alva Health Inc. has been granted protection for a method for detecting stroke from falls using a combination of wearable motion sensors and artificial intelligence.

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.