Illumina Inc. crushed analysts’ estimates for the third quarter, posting revenue of $794 million vs. the Street consensus of $716 million. Driving results were sequencing consumables, which racked up $500 million in the period, with clinical sequencing hitting 96% of pre-COVID-19 levels, up from 84% in the second quarter. Read More
The U.S. FDA is no longer reviewing lab-developed tests (LDTs) under the emergency use authorization (EUA) program, which eliminates product liability protection for them under the Public Readiness and Emergency Preparedness (PREP) Act. Harvard’s Michael Mina said on an Oct. 30 press briefing that the PREP Act question could be extended to LDTs administratively even outside EUA review, a move he said is under consideration based on his communications with Assistant Secretary for Health Brett Giroir. Read More
Ocular Therapeutix Inc. and Affamed Therapeutics Ltd. entered a license and collaboration agreement to develop and commercialize Dextenza and OTX-TIC in greater China, South Korea and the Association of Southeast Asian Nations markets. Read More
Precision oncology company Genetron Holdings Ltd. has entered an exclusive licensing agreement for Seq-MRD, a diagnostic assay for detecting and monitoring minimal residual disease (MRD) in select hematologic cancers from med-tech startup Hangzhou Immuquad Biotechnologies Co. Ltd. Read More
PARIS – Fineheart SA has announced the success of a 30-day preclinical trial to evaluate its implantable cardiac output management system (ICOMS) for patients suffering from severe heart failure. The device was well-tolerated with no related adverse events seen during the 30 days. Read More
Under the right circumstances, a single mouse can be as good as a group of eight or 10 animals in predicting whether a tumor will respond to a drug, researchers reported at the 2020 EORTC-NCI-AACR (ENA) Molecular Targets meeting on Saturday. The single-animal approach “allows incorporation of more tumor models within the same resource constraints,” Peter Houghton told reporters at a press conference previewing ENA highlights. Read More
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: FDA posts list of essential devices, drugs; Members of Congress query NIH’s Collins on RADx program; Imminent malware threat reported; CDC posts telehealth report; CMS unveils seven AI competition finalists. Read More
Keeping you up to date on recent developments in neurology, including: Software developed to objectively calculate white matter hyperintensities; CSF biomarkers point to underlying cause of neural damage in COVID-19; Scientists discover how cryptochrome mutation leads to sleep disorder; Physical labor significantly increases the risk of dementia. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Copan Diagnostics, Neuroptics, Veracyte. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Accuhealth, Applied DNA Sciences, Bendit Technologies, Biocartis Group, Bone Therapeutics, Catalent Pharma Solutions, Closedloop.ai, DNAfit Life Sciences, Exact Sciences, Fitbit, Genomic Health, Health Catalyst, Livongo Health, Mammoth Biosciences, Mayo Clinic, Myapps, Natera, Optomec, Oxsed, Prenetics, Ping An, Premier Medical Laboratory Services, Progressive Care, Sanara Medical, Teladoc, Telli Health, Vocalis, Zerigo. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Medtronic Canada, Perkinelmer. Read More
