The emergence of the Omicron variant of the SARS-CoV-2 virus has sparked a vigorous reaction around the globe, which in the U.S. includes steps taken by the Biden administration to ensure that the roughly 100 million people who have received an initial vaccination regime will receive a booster if eligible. The administration also reported Dec. 2 that it will take steps to ensure that home testing will be covered by private payers, all of which amounts to a massive boost in business for manufacturers of vaccines and tests despite concerns about how the Omicron variant might affect vaccine and test performance.

PERTH, Australia – The FDA has cleared Immunexpress Inc.’s 510(k) for its Septicyte rapid diagnostic test for sepsis that quantifies the relative expression levels of genes involved in a patient's immune response to infection to aid in a diagnosis in one hour for patients suspected of sepsis. The test uses peripheral blood gene expression biomarkers to provide a probability of sepsis in patients presenting with clinical signs of systemic inflammation.

TORONTO – Koios Medical Inc. has received Health Canada approval for its DS Smart Ultrasound decision support software, which the company said accurately interprets breast ultrasound examinations. Company CEO Chad McClennan told BioWorld greater accuracy will provide early cancer detection rates, while reducing costly false positives and unnecessary biopsies.

Memed Diagnostics Ltd. has published new data from an EU Commission funded clinical trial evaluating its blood test for differentiating bacterial and viral infections. The prospective, multicenter cohort study, titled “AutoPilot-Dx,” was carried out in emergency wards in Italy and Germany. The goals of the study were to validate the performance of Memed’s BV test in a broad pediatric population with respiratory tract infections or fever without source and estimate its potential to impact antibiotic use.

GE Healthcare Ltd. is expanding its cancer technology capabilities through new alliances with artificial intelligence (AI) companies and researchers. The company said it is teaming up with U.K.-based Optellum Ltd. to advance lung cancer diagnostics, as well as collaborating with the University of Cambridge to develop an AI application that integrates cancer patient data from multiple sources into a single interface.

PARIS – Diagnostic Medical Systems SA (DMS) is spinning off its medical imaging division into Asit Biotech NV. This agreement, between two firms listed on the Euronext exchange, involves French med-tech company DMS merging its flourishing medical imaging business with the Belgian biopharmaceutical firm and acquiring a controlling stake in the company.

Lunit Inc. has raised $61 million in a fundraising round, getting it closer to its planned list on South Korea’s Kosdaq. “We will use these funds as working capital to research and develop artificial intelligence (AI) products, as well as developing our global market,” a Lunit spokesperson told BioWorld. Seoul, South Korea-based Lunit secured new investors for this round, including U.S. life science investors Healthquest Capital, Casdin Capital LLC, and The American Cancer Society’s Brightedge fund. Asia Pacific-based global health care investors included Tybourne Capital Management Ltd. and NSG Ventures Pte. Ltd.

PARIS – Pcube-Lab BV has closed a $4.75 million funding round to deploy its eye tracking technology, Neuroclues, in Europe and the U.S. This technique helps with early diagnosis of neurological disorders such as Parkinson's, multiple sclerosis and Alzheimer's disease.

PERTH, Australia – Medical device and analytics company Trajan Group Holdings Ltd. has acquired the business and manufacturing facilities of Axel Semrau GmbH & Co., based in Sprockhövel, Germany, for AU$26 million (US$18.7 million), expanding the company’s global operations. Axel Semrau develops and manufactures laboratory automation and chromatography software and detection systems. The acquisition is the company’s most significant to date and broadens the company’s manufacturing base in Europe, Trajan founder and CEO Stephen Tomisich told BioWorld.