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.

Last year, artificial intelligence (AI)-focused Caption Health Inc. won the U.S. FDA’s nod for software that guides untrained clinicians step-by-step in providing a cardiac ultrasound exam, a process normally performed by a highly skilled specialist. Now, the Brisbane, Calif.-based company has published data showing nurses without prior ultrasound experience who used Caption Guidance software captured ultrasound images of diagnostic quality to assess known cardiac conditions.

If the SARS-CoV-2 virus has achieved anything useful in the world of in vitro diagnostics, it’s that the associated pandemic has shone a bright and unsparing light on the respective merits of diagnostic and surveillance testing. Harvard University’s Michael Mina, an assistant professor of epidemiology, was one of several academic researchers who took up the gauntlet yet again in opposition to what they characterized as a gross misunderstanding of the respective roles of these types of tests, a misunderstanding they said must be addressed if the pandemic is to be corralled.