The granting of emergency use authorization by the U.S. FDA to Roche AG for its four-in-one molecular test for SARS-CoV-2, Influenza A/B viruses and respiratory syncytial virus will allow the company to quickly bring the test to near-patient care environments ahead of the flu season, to address a real need in the marketplace, Ian Parfrement, head of the point of care customer area, at Roche Diagnostics, told BioWorld.
Sherlock Biosciences Inc. is on the case of the missing tests – the lack of diagnostic testing for sexually transmitted infections, that is. Sherlock’s over-the-counter molecular, disposable tests combine CRISPR and synthetic biology chemistries to provide results in 30 minutes in the privacy of the user’s home.
London, Ontario-based Deep Breathe Inc. filed for protection of a wearable ultrasound sensor that is used to obtain ultrasound data, and digital ultrasound images are processed using a machine learning model to predict the probability of lung sliding and detection of pneumothorax (collapsed lung) if lung sliding is absent or deem it likely if lung sliding is present.
Researchers from the University of Chicago and Northwestern University have filed for protection of an mobile application to track individualized patient needs, engagement in continuous positive airway pressure machine use, and the correlation of risk behaviors to determine sleep apnea treatment progress.
Molecular diagnostics company Genetic Signatures Ltd. is gearing up to launch its Easyscreen gastrointestinal parasite detection kit in the U.S. following its first FDA 510(k) clearance.
The saga of Illumina Inc.’s attempt to reacquire Grail Inc., seems to have come to an end with a capitulation to market regulatory authorities, but Illumina has chosen to spin off Menlo Park, Calif,-based Grail rather than sell the company outright.
The €1.5 million ($US1.63 million) in pre-seed funding recently raised by En Carta Diagnostics SA is “key” for the company to be able to develop its point-of-care molecular diagnostics kits and generate clinical data, Guillaume Horreard, CEO at En Carta told BioWorld.
Astrazeneca plc’s blockbuster Enhertu continued to garner attention as new data released at the American Society of Clinical Oncology (ASCO) annual meeting show the antibody-drug conjugate demonstrated strong progression-free survival in metastatic breast cancer patients. Puma Biotechnology Inc. had advances of its own at ASCO with new biomarker findings from a phase II study of alisertib, an aurora protein kinase 2 inhibitor, in endocrine-resistant metastatic breast cancer.
The U.K.’s National Institute for Health and Care Excellence recent recommendation that selective internal radiation therapy could be used to treat neuroendocrine tumors that have metastasized to the liver is a boon for patients suffering from the disease. However, there is not yet a clear pathway for these patients to receive the therapy via the national health service.
Urteste S.A. has developed a urine-based diagnostic test for the early detection of brain tumors. The prototype, which can detect the activity of brain-specific enzymes in urine, is a breakthrough test and the first solution of this type in the world, Grzegorz Stefański, CEO and co-founder of Urteste S.A., told BioWorld.