Inivata Ltd. published new data from a prospective clinical study assessing its Radar diagnostic test in head and neck squamous cell carcinoma (HNSCC). Results from the Liquid Biopsy for Minimal Disease Detection in HNSCC (LIONESS) study suggest the assay demonstrated 100% specificity in patients with no recurrence and 100% sensitivity in patients with clinical recurrence. The personalized assay can track up to 48 tumor-specific variants in a patient using a blood sample. Last year the test was granted breakthrough device designation by the FDA. Read More
Blue Note Therapeutics Inc. took a new approach to expanding its pipeline of prescription digital therapeutics (PDT) with an exclusive licensing agreement with the University of Sydney for Conquerfear, a metacognitive intervention that helps cancer survivors cope with the fear of disease recurrence. Blue Note has developed its PDTs internally to date but hopes to convert Conquerfear’s elements, which are typically delivered face-to-face, into a PDT for the U.S. and Canada. As a digital therapy, the program could potentially reach many more patients. Read More
Quris Technologies Ltd. has inked an agreement with Merck KGaA to assess its BioAI safety prediction platform. The partnership will compare the Quris’ artificial intelligence (AI)-based platform with traditional in vivo and in vitro approaches of evaluating drug safety concerns. Read More
Ethicon Endosurgery Inc. has had its hands full protecting a patent for robotic surgical systems, but the U.S. Court of Appeals for the Federal recently delivered some good news. The Federal Circuit affirmed the results of an inter partes review (IPR) of three claims for an endocutter patent, leaving Ethicon with another win in its efforts to sustain a critical patent for the robotic surgical space, and major player Intuitive Surgical Inc. coming out on the short end of the argument. Read More
Despite big wins in precision oncology – such as last year’s accelerated FDA nod for Amgen Inc.’s Lumakras (sotorasib) in KRAS G12C-mutated locally advanced or metastatic non-small-cell lung cancer – industry has barely scratched the surface of the field’s potential. Part of the problem is on the scientific front. Only about a third of patients are currently eligible for targeted therapy, since the majority of patients “do not have a known therapeutic vulnerability for which we have a drug match,” Keith Flaherty, director of clinical research at Massachusetts General Hospital, said during a Feb. 14 session at the BIO CEO & Investor Conference. “And that’s a big problem.” Read More
The U.K. National Institute of Health and Care Excellence has endorsed the use of stereotactic radiosurgery as a treatment of trigeminal neuralgia (TN) after hearing from a patient group, promising more clinical bandwidth for these systems. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Biocardia, Lungpacer Medical, Magnus Medical, Mainz Biomed, Nexstim, Precision Biomonitoring, Sqi Diagnostics, Trinity Biotech. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Datar Cancer Genetics, Motus GI, Sequana Medical. Read More
