A research team from the Technical University of Munich (TUM) in Germany has for the first time managed to integrate the dark-field X-ray technique into a CT scanner suitable for clinical application. They have just published an article describing how they integrated this technology, in the journal Proceedings of the National Academy of Sciences.

Myriad Genetics Inc. is launching a new suite of genetic tests designed for personalizing chemotherapy treatment. The Precise oncology offering includes Myriad’s precise tumor molecular profile test and two companion diagnostic tests, Mychoice CDx and Bracanalysis CDx. The company said the combination of germline, somatic and companion testing aims to maximize information for oncologists as they assign individual treatment plans. Results from each test are gathered as a single report accessed on an online portal.

Norwegian diagnostics company Cardinor AS landed a CE mark for its Secretoneurin (SN) ELISA (enzyme-linked immunosorbent assay). The blood-based test detects SN, a small 33-amino acid neuropeptide produced by neuroendocrine and heart muscle cells. Studies have shown the biomarker is a predictor of mortality in major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with cardiovascular disease (CVD) and severe sepsis.

Developed by Infrascan Inc., the FDA-cleared Infrascanner device was touted as the first hand-held device to help detect bleeding in the skull and supported financially by the U.S. military anxious to treat moderate to severe traumatic brain injury in wounded service members. The FDA has now expanded the Infrascanner’s use to traumatic intracranial hematomas or brain bleeds in pediatric patients aged 2 years and older.

Ceros Capital Markets completed a $15 million series D funding round for Pristine Surgical LLC, its latest major investment in the medical device space. The funds will be used to advance the commercialization of Pristine’s single-use visualization platform for surgical and diagnostic endoscopic procedures.

For about one-third of stroke patients, the cause of their cerebrovascular accident (CVA) is unknown at the time of hospitalization, but crucial to determine to prevent subsequent strokes. Electrocardiogram (ECG) monitoring in the 24 to 48 hours after a stroke detects atrial fibrillation (AF) in about 5% of patients. Remote monitoring with a noninvasive device detects far more cases and provides the opportunity to quickly head off secondary strokes, preserving lives and reducing costs of care, according to a study published by Royal Philips NV researchers.

The Biden administration sees the $15.6 billion just provided by Congress as inadequate funding for the pandemic, particularly given the administration’s new test-to-treat initiative, and will continue to press Congress for the remaining $6.9 billion requested by the White House, said Tom Inglesby, senior advisor for the White House COVID response team, at the American Clinical Laboratory Association annual meeting.

Sense Biodetection Ltd. is preparing to launch a new rapid, disposable, point-of-care molecular diagnostic test for COVID-19 in Europe after securing CE marking for the platform. The company will make its Veros COVID-19 test available in Ireland, Benelux and Nordic countries this quarter before expanding to other European markets.

The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.

The news from Quanterix Corp. has come fast and furiously this week. The company reported that Chairman and CEO Kevin Hrusovsky will step down on April 25 and become executive chairman of the board, while current company President Masoud Toloue will assume the CEO position and join the board of directors. Hrusovsky became CEO in 2014 and Toloue joined Quanterix in June 2021 from Perkinelmer Inc. The company also revealed that it has built on its collaboration with Indianapolis-based Eli Lilly and Co. for new tools to diagnose, monitor and treat Alzheimer’s disease (AD) and presented its fiscal 2021 financial results, which showed a 28% increase in total revenue, largely attributable to its neurology segment.