Grail Inc. is teaming up with Quest Diagnostics Inc. to support the upcoming launch of its multicancer blood test. The early cancer detection test, called Galleri, is slated to begin rolling out in the second quarter of 2021. Quest’s 2,200 patient service centers and network of 5,000 mobile phlebotomists will help to collect blood samples for Galleri once the test becomes available in the U.S. Read More
The first Senate hearing for the nomination of Xavier Becerra as Secretary of Health and Human Services included the predictable questions about his qualifications, given his position as attorney general for the state of California. However, the candidate repeatedly emphasized price transparency for both hospitals and drug manufacturers, the latter of which are still laboring under the perception that price gouging is a common practice. Read More
Berlin – Fresenius SE & Co. KGaA reported that its global division, Fresenius Medical Care, and its Frenova Renal Research division have enrolled the first subjects in its new initiative to develop the largest genomic registry in the world to focus on kidney disease. At the same time, the German firm also announced that Ali Gharavi, chief of the division of nephrology at Columbia University Irving Medical Center, will lead the project and provide scientific guidance as principal investigator. Read More
"Step up, speak up" could be the next mantra for COVID-19 screening at airports, universities and large employers if Vocalis Health Inc.'s screening tool takes off – and its recent CE mark approval makes that more likely. Vocalis reported that a large study found the tool, which uses AI-powered vocal biomarkers, had greater than 80% sensitivity and specificity, even in asymptomatic individuals. Read More
Diagnostics company Sphingotec GmbH is looking to break into the U.S. market with a pair of biomarker assays that could help determine the best treatment for critically ill patients at risk for septic shock. The two assays, which are run on the company’s point-of-care Nexus IB10 immunoassay platform, measure bioactive adrenomedullin (bio-ADM), a hormone that maintains endothelial function; and dipeptidyl peptidase 3 (DPP3), an enzyme that inactivates angiotensin II when released into the blood. Read More
New hires and promotions in the med-tech industry, including: 908 Devices, B. Braun Medical, Co-Diagnostics, Ibex Medical Analytics, Pathogenx. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adaptive Biotechnologies, Astarte Medical, Evasc Neurovascular, Genesiscare, Icometrix, Labcorp, Medcura, Neuroone, Perkinelmer, Personal Genome Diagnostics, Pixcell, Soliton, Stevara, Transenterix, Zimmer Biomet. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Endoclot Plus, Inova Diagnostics, Newronika, Rhythmlink. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: OIG: Noridian overpaid for facet-joint injections; Hill-Rom patient lift recalled; New legislation directed to heart valve disease. Read More
Keeping you up to date on recent developments in oncology, including: MR touted as potential screening modality for prostate cancer; Classifying variants of unknown significance; Tumor neoantigens can inhibit immune response; MEK perhaps a useful target in some bladder cancers. Read More
