Nanthealth Inc. has received U.S. FDA clearance for a whole exome sequencing test to determine overall tumor mutational burden (TMB) in cancer tissue. Known as Omics Core, the first-of-its-kind in vitro diagnostic test is available now as part of Nanthealth's GPS Cancer molecular profiling suite.
BOSTON – For diagnosing nonalcoholic steatohepatitis (NASH), liver biopsy is "the reference standard," Dean Hum, president of Genfit Corp., told BioWorld MedTech. "I'm not going to call it the gold standard."
TORONTO – On average, radiology specialists diagnose fewer than 50% of cases of collapsed lung or pneumothorax using chest X-rays, said systems design engineer Hamid Tizhoosh. The Insignio system developed at Tizhoosh's Kitchener, Ontario-based Kimia Lab has gone further by identifying 75% of cases of collapsed lungs using artificial intelligence (AI) to search a database of 550,000 patients and compare 30,000 cases of pneumothorax there to X-rays of new patients with unknown conditions.
Singapore-based Vela Diagnostics Holding Pte. Ltd. has received U.S. FDA authorization via the de novo approval pathway for an in vitro diagnostic test to detect HIV-1 genomic drug resistance mutations (DRMs). The Sentosa SQ HIV-1 Genotyping Assay – the first HIV-1 genotyping next-generation sequencing (NGS) assay to win an FDA nod – uses plasma of patients infected with HIV-1 to detect HIV-1 Group M DRMs in the protease, reverse transcriptase and integrase regions of the pol gene in a single test.
PERTH, Australia – Sydney-based molecular diagnostics company Genetic Signatures Ltd. is poised to extend its global footprint to the U.S. and Europe following its AU$35 million (US$24 million) capital raise.
A subtype of schizophrenia is related to abnormally high brain levels of hydrogen sulfide (H2S), which has important implications for the development of new treatments, according to a study by researchers at the RIKEN Center for Brain Science (CBS) in Japan.
PARIS – Myriade SAS reported the commercial launch of its Videodrop technology at the second congress of the French Society of Extracellular Vesicles (FSEV) held in October in Nantes. This new nanoscale imaging technique captures all nanoparticles ranging from 30 nm to 10 μm in a droplet of solution (5-10μl volume), without initial data labeling.
Cytovale Inc., a San Francisco-based medical technology company, has picked up $15 million in financing to advance its technology that enables the early detection of sepsis in the emergency department. Specifically, the company raised $7.4 million in an extension of series B equity financing, co-led by existing investors Breakout Ventures and Blackhorn Ventures. Western Technology Investment also participated, providing a venture debt facility to the company.