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.

Following steady expansion of its base among global pharmaceutical companies, Correlia Biosystems Inc. has secured the capital needed to make its nanotechnology-based immunoassay platform commercially available. The company received an infusion of $7 million in series A financing in a round led by Neotribe Ventures with participation by Cota Capital, the Regents of the University of California and others.

The draft version of the U.S. Medicare national coverage analysis for blood-based biomarker tests for colorectal cancer (CRC) engendered a large body of support, but several stakeholders recommended that the Centers for Medicare & Medicaid Services (CMS) avoid prescriptiveness regarding the sensitivity and specificity for any tests that would be covered under the policy.

Endoscopic ultrasound-guided biopsy startup Limaca Medical Ltd. has raised $1.25 million of a $1.5 million round to advance its next-generation Precision device. The company said it will use the funds to complete first-in-human procedures, conduct postmarket clinical studies and gain regulatory approvals of Precision for gastrointestinal (GI) system and adjacent organ tumors.

Hologic Inc. has gained approval from the U.S. FDA to add a diagnostic claim to its HIV type 1 viral load monitoring assay. This makes the Aptima HIV-1 Quant Dx assay the first dual-claim assay in the U.S., allowing both viral load monitoring and diagnosis. For laboratories that use the assay, the dual claim allows for consolidated testing on one automated platform, adding to efficiency.