Recent advances in biomarkers and imaging capabilities have improved the diagnosis of Alzheimer’s disease (AD). Fujirebio Diagnostics Inc. aims to further expand the arsenal of AD diagnostics with its Lumipulse G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic test. On Wednesday, the company said it had filed a 510(k) submission with the U.S. FDA for premarket clearance of the Lumipulse G β-Amyloid IVD.

Salient Bio launched a robotics-driven PCR test for COVID-19 with 99% for use in mass testing for the virus. The company says the "fastest ever" test notifies users of test results in less than a day and is priced to be cost effective for businesses. Salient plans to expand the number of tests utilizing the modular diagnostics platform in 2021 to include a range of pathogens. Even with vaccines on the horizon in the coming months, the London-based company expects brisk demand for its product.

PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. is acquiring Scintec Diagnostics GmbH subsidiary Therapharm GmbH in a deal worth AU$33 million (US$24.24 million) plus royalties. Zug, Switzerland-based Therapharm has developed a portfolio of radiolabeled diagnostic and therapeutic products, and the deal brings Telix a new targeting asset in hematology, Telix CEO Chris Behrenbruch told analysts during a Dec. 1 conference call.

TORONTO – The Fionet Rapid Response Group formed by Toronto’s Fio Corp. and Relay Medical Corp. has received COVID-19 lateral flow rapid diagnostic tests (RDTs) from the European division of Abbott Laboratories Inc., Switzerland’s Roche Diagnostics AG and North York, Ontario’s Proprietary Innovation Labs Inc. for operation with its mobile testing and tracking platform.

HONG KONG – Singapore-based X-Zell Biotech Pte. Ltd. has emerged as the winner of the Medtech Innovator Asia Pacific 2020 Accelerator program, as determined by a live virtual audience vote. Winning the competition, organized by Medtech Innovator and the Asia Pacific Medical Technology Association (APACMed), earned X-Zell a $150,000 non-dilutive grand prize to advance its business goals and mission.

LONDON – Long-awaited guidance on the EU regulation for in vitro diagnostics (IVD) that comes into force in May 2022 arrived as the industry increased its calls for implementation to be postponed, citing the extent to which the COVID-19 pandemic has derailed work on bringing products into compliance with the new rules.

Kantaro Biosciences LLC, a joint venture between the Mount Sinai Health System and RenalytixAI, has received emergency use authorization from the U.S. FDA for its semi-quantitative SARS-CoV-2 IgG antibody test kit. Known as COVID-Seroklir, the test determines the presence and precise level of IgG antibodies. It has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain.

A new sensor developed by The Charles Stark Draper Laboratory Inc. measures your bioelectrical field. It may sound like “polishing your aura” but, in reality, it stands to be the most significant transformation of the electrocardiogram in decades. The sensor adapts technology developed for navigation and guidance systems to provide three-dimensional (3D) measurement of the heart's bioelectric field.

New artificial intelligence capabilities will be integrated into widely used genomic testing for breast cancer under a new partnership formed by Agendia Inc. and Paige.ai. The two companies are working together to enhance the genomic information from Agendia's Mammaprint and Blueprint diagnostic tests with AI-based digital diagnostics provided by Paige with the goal of redefining precision oncology.