Pillar Biosciences LLC hopes to build a stronger foundation for its multi-cancer in vitro diagnostic, Oncoreveal Dx. The company filed a supplemental application for U.S. FDA premarket approval of eight additional types of cancer, which the agency accepted for review. The assay received FDA premarket approval for use in non-small cell lung cancer (NSCLC) and colon cancer in August 2021.
A new cancer genomic test co-developed by Illumina Inc. and Merck & Co. Inc. will soon be available globally, excluding the U.S. and Japan. The research use only Trusight Oncology 500 HRD test is designed to identify genetic mutations used in the evaluation of homologous recombination deficiency (HRD), a signal that can indicate tumor formation. The product combines HRD technology from genetic test maker Myriad Genetics Inc. and next generation sequencing (NGS) technology from Illumina.
A new large-scale study has found combining artificial intelligence (AI) and radiologists to analyze breast cancer screenings can lead to better patient outcomes, when compared with unaided radiologists and the use of AI alone. The study, published in The Lancet Digital Health, evaluated the performance of an AI decision referral system developed by Vara (MX Healthcare GmbH).
A presentation at the American Society of Clinical Oncology (ASCO) 2022 annual conference demonstrated that the Dxcover Cancer Liquid Biopsy differentiated between patients with cancer and healthy controls and detected more than 90% of stage I malignancies across a broad range of cancers. Dxcover Ltd. provided more details on its new approach to the search for reliable, rapid screening for multiple malignancies at the 12th International Conference on Clinical Spectroscopy on June 21.
The U.S. CMS has suspended the rulemaking for payment for radiation oncology for Medicare patients, but the suspension hasn’t assuaged the fears of industry and health care professionals. Anne Hubbard, health policy director for the American Society for Radiation Oncology told BioWorld that despite the suspension, CMS’s interest in the much-criticized proposal for site-neutral payment is unlikely to ebb anytime soon.
Grail LLC reported a new study with the U.K.’s NHS to assess the clinical utility of its Galleri multi-cancer early detection test (MCED) for reducing late-stage cancer diagnoses. Menlo Park, Calif.-headquartered Grail presented the study design during the American Society of Clinical Oncology (ASCO) meeting in Chicago. The randomized controlled trial will enroll 140,000 asymptomatic participants aged 50-77 living across England to determine if Galleri can find cancers at an early stage when they are less advanced.
University of Edinburgh spinoff Biocaptiva Ltd. has raised an additional $2.6 million (£2.1 million) in seed financing for its cell free DNA (cfDNA) capture device, Biocaptis. Business angel syndicate Archangels led the round, with participation from Scottish Enterprise and Cancer Research Horizon, the innovation engine of Cancer Research UK.
U.K.’s Angle plc has become the first company to receive a U.S. FDA product clearance for harvesting intact cancer cells for analysis. Angle reported it scored FDA clearance for its Parsortix system for the capture and harvest of circulating tumor cells (CTCs) from metastatic breast cancer patient blood. Shares in the AIM-listed company soared by more than 50% following the news.
In a deal potentially worth more than $1.4 billion, Sichuan Kelun Pharmaceutical Co. Ltd. has out-licensed a large molecule drug in cancer to Merck & Co. Inc. for development and commercialization outside mainland China, Hong Kong, Macao, and Taiwan.
The Embold fibered detachable coil developed by Boston Scientific Corp. to obstruct or reduce the rate of blood flow during therapeutic treatment in the peripheral vasculature, has won U.S. FDA 510(k) clearance.
