PERTH, Australia – Molecular diagnostic company Speedx Pty Ltd. has invested in a Perth-based startup that makes the raw materials needed for polymerase chain reaction (PCR) COVID-19 tests. The two companies will work to develop a new at-home rapid PCR test to ensure Australia can become self-sufficient with producing PCR tests. A rapid PCR test that gives an accurate result in minutes could be used at home or work. Read More
Centogene NV and Twist Bioscience Corp. are linking up to develop custom assay kits for rare disease testing. The companies said the collaboration aims to make genetic tests more accessible to rare disease patients. Financial details were not disclosed. Centogene, which dubs itself the “rare disease company” is positioning to be a frontrunner in the testing market. The global rare disease genetic testing market size was valued at $812.3 million in 2019 and is projected to register a CAGR of 10.9% from 2020 to 2027. Read More
FDA preemption of state liability law has proven controversial on a number of occasions, a fact of life resurrected by a case arising out of the Supreme Court of the State of Mississippi. The court declared that the FDA must invoke the rulemaking process for its regulation of medical product labels. Read More
Two innovators in the concussion assessment space have advanced their products with new funding and new clearances. Brainscope Co. Inc. secured $35 million in capital through an intellectual property-based funding arrangement with Aon plc to expand access to and develop new applications for its EEG-based product. Syncthink Inc. received a second FDA clearance for its Eye-Sync platform for mild traumatic brain injury diagnosis. Read More
Even though the U.S. already has a National Plan to Address Alzheimer’s Disease, a bipartisan group of U.S. senators is adding its voice to that of nearly 200 national organizations and experts in calling for more. In a recent letter to Health and Human Services (HHS) Secretary Xavier Becerra, the 15 senators requested that he make reducing the prevalence of dementias a departmental priority. Read More
The U.S. Office of Inspector General (OIG) said a review of claims for implant of neurostimulation devices indicates that many of these claims lack the data to ensure that the devices were appropriately implanted. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Aspira Women’s Health, Capnostics, Dariohealth, Genoox, Healthverity, Mynd Life Sciences, Neurometrix, Ondine Biomedical, Pavmed. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Perkinelmer, Venclose. Read More
