HONG KONG – Wuxi Diagnostic Investment (Cayman) Ltd. has raised $150 million in a series B financing round, while netting a number of new investors along the way. The new investors to come on board include Thermo Fisher Scientific Inc., Shiyu Capital, ABC International Holdings Ltd., Sunland Capital and CCBI Tech Venture.
Keeping you up to date on recent developments in diagnostics, including: Atherosclerosis precedes clonal hematopoiesis; AI-driven tool to assess kidney function; Deep learning-powered classification of lung cancer types.
The U.S FDA’s response to the pandemic has been all-consuming, but epidemiologist Michael Mina of Harvard blasted the agency’s handling of rapid testing. Mina said the agency is in possession of emergency use authorization filings for rapid antigen tests that should be acceptable, but that the FDA is “the only bottleneck” in the rapid antigen testing pipeline.
The National Institutes of Health selected Pixcell Medical Ltd.’s Hemoscreen hematology analyzer as part of the six-year Risk Underlying Rural Areas Longitudinal (RURAL) research study, aiming to gain insight into the specific health-related concerns of the rural southeastern United States' population. The RURAL study is funded by the National Heart, Lung and Blood Institute and aims to understand health concerns specific to rural communities in the South, particularly related to increased rates of heart, lung, blood and sleep disorders.
Diagnostics company Sphingotec GmbH is looking to break into the U.S. market with a pair of biomarker assays that could help determine the best treatment for critically ill patients at risk for septic shock. The two assays, which are run on the company’s point-of-care Nexus IB10 immunoassay platform, measure bioactive adrenomedullin (bio-ADM), a hormone that maintains endothelial function; and dipeptidyl peptidase 3 (DPP3), an enzyme that inactivates angiotensin II when released into the blood.
Berlin – Fresenius SE & Co. KGaA reported that its global division, Fresenius Medical Care, and its Frenova Renal Research division have enrolled the first subjects in its new initiative to develop the largest genomic registry in the world to focus on kidney disease. At the same time, the German firm also announced that Ali Gharavi, chief of the division of nephrology at Columbia University Irving Medical Center, will lead the project and provide scientific guidance as principal investigator.
Grail Inc. is teaming up with Quest Diagnostics Inc. to support the upcoming launch of its multicancer blood test. The early cancer detection test, called Galleri, is slated to begin rolling out in the second quarter of 2021. Quest’s 2,200 patient service centers and network of 5,000 mobile phlebotomists will help to collect blood samples for Galleri once the test becomes available in the U.S.
Lexagene Holdings Inc. has successfully configured its Miqlab system to detect the U.K. and South African variants of SARS-CoV-2. The open-access point-of-care system can simultaneously screen for multiple respiratory pathogens and identify COVID-19 strains. Lexagene started studies to support its filing for U.S. FDA emergency use authorization (EUA) in late December 2020. If authorized, it would be the first open-access point-of-care (POC) device to gain an EUA.
The U.S. Centers for Medicare & Medicaid Services (CMS) has determined that the time has come to offer Medicare coverage for blood-based in vitro diagnostics as a screening tool for colorectal cancer (CRC), but there’s one catch: At present, there is no such test approved by the FDA that qualifies under the terms of the coverage memo, making this a null coverage proposition, at least for the time being.
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