bioMérieux, a world leader in the field of in vitro diagnostics, today announces the submission of the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid to the U.S. Food and Drug Administration (FDA) for 510(k) review. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in approximately one hour.

Seegene, Inc. ("Seegene"), a global leader in molecular diagnostics, announced today that its U.S. subsidiary, Seegene USA, Inc. ("Seegene USA"), has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the Allplex™ HSV-1&2/VZV/MPXV Assay, a multiplex real-time PCR assay designed to simultaneously detect multiple viral pathogens associated with clinically overlapping lesion presentations.

Only taking urine dry chemistry and urine formed element as the basic detection of urine routine is still insufficient in the diagnosis and differential diagnosis of urinary system diseases.

bioMérieux, a world leader in the field of in vitro diagnostics, today announces the launch of GENE-UP® PROBIOTIC SPECIES ID, a first-of-its-kind commercialized species-level identification PCR solution for in-house quality control teams and external laboratory partners. This new solution verifies dietary supplement label claims in 90 minutes or less, helping bypass the cost, complexity, and delays of traditional workflows.

Visby Medical, the at-home diagnostics company, today announced U.S. Food and Drug Administration (FDA) clearance for the Visby Medical Flu and COVID-19 Test, the first multi-viral at-home PCR test. This marks Visby’s second over-the-counter PCR test and expands the company’s growing portfolio of rapid molecular diagnostics designed for home use.

altona Diagnostics today announced that its FlexStar® STI panel has obtained CE marking under Regulation (EU) 2017/746 (IVDR). This completes the IVDR transition for the company’s modular and adaptive STI testing portfolio, enabling laboratories to configure customizable multiplex panels for up to 7 sexually transmitted pathogens in a single sample.

bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver* application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel**. This automated, multiplex PCR*** test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients.

Cepheid, a Danaher company, announced today that it has received CE marking under the in vitro medical device regulation (IVDR) for the Xpert GI Panel. This multiplex PCR test is designed to enable fast, accurate detection of 11 clinically relevant gastrointestinal (GI) pathogens from a single patient sample. Leveraging Cepheid's 10-color multiplexing technology on its GeneXpert® systems, the test offers a robust solution for simplifying GI testing workflows and delivering meaningful answers to clinicians.

Italian in vitro diagnostics firm Diasorin said on Sunday that the US Food and Drug Administration has issued 510(k) clearance and CLIA-waived the firm's first assay for use on the Liaison Nes platform.

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.