TORONTO – Vancouver, B.C.-based Sonic Incytes Medical Corp. is giving MRI a run for its money assessing chronic liver disease following a successful, CA$3.5 (US$2.6 million) seed round. That brings total funding to CA$8 million (US$5.92 million) for a hand-held ultrasound device that quantifies liver disease using 3D tissue sampling and analysis in approximately five minutes in a doctor’s office.
LONDON – Base Genomics Ltd. has raised $11 million in an oversubscribed seed round to commercialize a new liquid biopsy technology for detecting DNA methylation, invented in the U.K. at the Ludwig Institute for Cancer Research at Oxford University.
Keeping you up to date on recent developments in diagnostics, including: Improving diagnosis of prostate cancer; Assay system identifies mitochondria-targeting drugs for PD; Ovarian organoids implicate oviducts.
The latest U.S. FDA town hall for testing for the COVID-19 included a few updates on serological testing, but perhaps the most important take-away was when Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiology, advised attendees that performance expectations regarding next-generation sequence (NGS) testing for the SARS-CoV-2 virus will closely resemble those of conventional molecular testing.
As more COVID-19 antibody testing becomes available, one question has been on everybody’s mind: Does the presence of antibodies to SARS-CoV-2, the virus responsible for the global pandemic, mean that people are protected from future infection? To that end, Genscript Biotech Corp., of Piscataway, N.J., has applied for emergency use authorization (EUA) with the U.S. FDA to market a test that specifically recognizes neutralizing antibodies to SARS-CoV-2.
Fidget spinners are hand-held toys based on a roller bearing and three weighted lobes, which can spin freely, creating centrifugal force when activated manually.
Exact Sciences Corp., of Madison, Wis., detailed three studies of the Oncotype Dx Breast Recurrence Score test during the virtual 2020 American Society of Clinical Oncology Annual Meeting.
LONDON – After eight years in development, Memed Diagnostics Ltd. has secured CE marking for its point-of-care blood test, which is able to distinguish between bacterial and viral infections in 15 minutes.
The COVID-19 pandemic has demanded much of the FDA, and commissioner Stephen Hahn said on a June 1 conference call that “there have been hiccups along the way” as the enormity of the threat came into view. The agency’s use of emergency use authorizations (EUAs) has drawn criticism, but Hahn defended those EUAs and other regulatory flexibilities even has he declared that the FDA is not “walking away from” randomized, controlled clinical trials as the gold standard for premarket review.
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