The U.S. FDA has posted an immediately-in-effect policy document regarding clinical laboratory development of diagnostics for the pathogen responsible for COVID-19 disease. The agency said the policy allows a lab to use any diagnostic before the FDA has completed an exhaustive review of the test.
TORONTO – Montreal’s McGill University and the Montreal Neurological Institute-Hospital (The Neuro) have entered a research agreement with Pasadena, Calif.-based Fuzionaire Diagnostics Inc. to detect and treat neurodegenerative diseases through molecular imaging.
Keeping you up to date on recent developments in diagnostics, including: Chest CT bests assays in diagnosing Covid-19; Sweat sensor keeps tabs on stress; Oligodendrocyte-neural connections not just about myelin; Sharper look yields new potential kinase target in ovarian cancer.
San Diego-based Cortechs Labs Inc. has developed an automated PET image analysis tool that identifies changes in specific brain structures associated with Alzheimer’s disease, vascular dementia, epilepsy, multiple sclerosis and other neurological disorders.
Artificial intelligence still has a lot to prove when it comes to its relevance in improving health care. But one bright spot was a deal last July between Dublin-based Medtronic plc and San Francisco-based startup Viz.ai Inc. to use the latter’s AI system that’s designed to spot a large vessel occlusion automatically in CT angiogram images.
The second day of the FDA workshop on artificial intelligence (AI) in health care featured several interesting proposals, including that AI will be used in health care without the aid of a health care professional. John Martin, chief medical officer at Butterfly Network Inc., of Guildford, Conn., said the time is ripe for AI-assisted ultrasound in the home, which he claimed could reduce rehospitalizations in heart failure, one of the holy grails in U.S. government efforts to restrain health care spending growth.
Waveguide Corp. has launched the first portable, battery-powered nuclear magnetic resonance (NMR) device, Waveguide Formμla, offering rapid, on-site screening and diagnostics. The Cambridge, Mass.-based startup is looking to advance the product for use in detecting infectious diseases and cancer.
Asuragen Inc., an Austin, Texas-based molecular diagnostics company, has received good news from the U.S. FDA. The agency gave the green light for the company’s Amplidex Fragile X Dx and Carrier Screen Kit, which aims to detect a genetic condition known as Fragile X syndrome. The diagnostic kit determines the number of cytosine-guanine-guanine (CGG) repeats in the FMR1 gene to aid in the diagnosis of Fragile X syndrome and associated disorders, including Fragile X-associated tremor/ataxia syndrome and Fragile X-associated primary ovarian insufficiency.
Redwood City, Calif.-based Q Bio Inc., which is offering a quantitative assessment of personal health, has come out of stealth mode, scooping up $40 million in a series B funding round led by Andreessen Horowitz. The funds are earmarked to improve its proprietary platform and technology to make its preventive health services faster, better and more affordable for all.
Making routine diagnostic blood tests less invasive, easier, cheaper and more accessible is a worthy goal. But achieving it has eluded many, including former unicorn startup Theranos that boasted it had achieved precisely that but then was later exposed as a fraud. Established med-tech player Becton, Dickinson and Co. (BD) and Babson Diagnostics Inc. have established a long-term strategic partnership to bring laboratory quality, small-volume blood collection into the retail pharmacy setting.
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