The FDA has given a green light to Foundation Medicine Inc.’s Foundationone CDx as a companion diagnostic for Takeda Pharmaceutical Co. Ltd.’s Alunbrig to identify patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small-cell lung cancer (NSCLC). The approval comes as Laboratory Corp. of America Holdings (Labcorp) is launching a companion diagnostic to identify NSCLC patients with the KRAS mutation. NSCLC accounts for about 85% of all lung cancers, with an estimated 1.8 million new cases diagnosed each year worldwide. Of those, 3% to 5% carry the ALK gene mutation, which is often missed with standard testing methods. Read More
Patent protection in China has been a point of concern for device makers for some time, but so has patent piracy. The Peoples Republic of China has issued some amendments to its patent law that allow for adjustments and extensions to the term of a patent, changes that are a welcome bit of news for companies in the life sciences. Read More
PERTH, Australia – With FDA approval of its Guardian system to detect early heart attacks, Angel Medical Systems Inc. (Angelmed) will launch the device in the next six weeks in the U.S., and partner Hydrix Ltd. will launch the devices in eight Asia Pacific markets. Read More
KT Corp. took its first step into the digital therapies space by entering into an agreement with Neurosigma Inc. to develop electronic therapies to treat neurological and neuropsychological disorders, including attention deficit hyperactivity disorder (ADHD), depression and epilepsy. KT will support the design and development of Neurosigma’s next-generation versions of external trigeminal nerve stimulation (eTNS) products that incorporate artificial intelligence (AI), big data and cloud capabilities. Read More
The U.S. National Institutes of Health (NIH) has waded into the controversial question of the respective roles of rapid antigen and polymerase chain reaction (PCR) tests for detection of the SARS-CoV-2 virus, a question that roiled relations between the FDA and public health experts. According to NIH, three rapid antigen tests administered at three-day intervals offer the same level of sensitivity as PCR, a finding that will likely make itself felt in future communicable disease outbreaks. Read More
An exome sequencing study of more than 600,000 individuals of European and mixed American ancestry has identified more than a dozen genes, including five brain-expressed G protein-coupled receptors, that were associated with body mass index. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abigo Medical, Caredx, Diagonal Bio, Ensysce Biosciences, Essity, Eurofins, Myriad Genetics, Q2 Solutions. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biogx, Foundation Medicine, Sonoscape Medical. Read More
