Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*. The submission follows the Company's previously announced completion of the clinical and analytical performance studies supporting the test.

Alveo Technologies, Inc. (Alveo), a leader in portable molecular sensing solutions, today announced a strategic partnership with The University of Texas Medical Branch (UTMB) to develop point-of-care diagnostics for viral hemorrhagic fevers across West Africa. The point-of-care diagnostic will provide real-time pathogen detection at clinical sites in Nigeria and Sierra Leone, supporting UTMB's Lassa fever research program—a major international initiative.

Diasorin (FTSE MIB: DIA) announced today that it has received 510(k) clearance and CLIA waiver from the U.S. Food and Drug Administration (FDA) for its Group A Streptococcus (GAS) assay, to be used on the LIAISON NES Point-of-Care (POC) molecular diagnostics platform. This milestone follows the FDA clearance of the LIAISON NES FLU A/B, RSV & COVID-19 assay in December 2025, further expanding the platform’s menu and clinical utility.

The World Health Organization (WHO) is issuing, for the first time, recommendations on new near-point-of-care (NPOC) molecular tests for the diagnosis of tuberculosis (TB); easy-to-collect tongue swab samples to simplify and expand access to testing; and a cost-saving sputum pooling strategy to increase testing efficiency for TB and rifampicin-resistant TB.

Stay up-to-date with the latest happenings in the rapidly evolving field of In Vitro Diagnostics (IVD) in China.

Qure.ai, a global digital health company focused on AI-led medical diagnostics, has received a multi-million-dollar grant from the Gates Foundation to support the development of AI-enabled point-of-care ultrasound and create an open-source multi-modal health database aimed at improving lung disease detection in underserved regions.

Adaptive Biotechnologies said last week that its new subsidiary Digital Biotechnologies has held an initial closing of its Series A preferred stock financing and expects to raise up to $15 million in the round.

Following decades of cumulative efforts, a number of infectious disease tests and technologies broke new ground in 2025, hinting at rapid advances in the development of new systems and assays. But the past year also saw its fair share of upheaval, possibly suggesting more may be in store in 2026.

The Global Health Innovative Technology (GHIT) Fund said Monday that it has invested ¥70 million ($460,000) in the development of a prototype molecular assay to detect mpox.

Scout Health announced Wednesday that it has been awarded up to $6 million in funding support from the antimicrobial resistance nonprofit CARB-X. The firm plans to use the funding to finalize development of a next-generation version of its rapid point-of-care system and assay for chlamydia and gonorrhea and hopes to soon begin pilot studies in low- and middle-income countries (LMICs).