- In February 2025, ABL Diagnostics announced it would begin manufacturing and commercializing a comprehensive range of UltraGene PCR tests acquired from its parent company, Advanced Biological Laboratories, covering more than 100 pathogens for infectious disease diagnostics across various conditions, and plans to integrate these with its DeepChek sequencing tools to expand its footprint in precision medicine, thereby reinforcing its position in advanced molecular diagnostics
- In January 2025, QIAGEN received U.S. FDA clearance for its QIAstat-Dx Gastrointestinal Panel 2 Mini B&V, a targeted syndromic test designed to detect bacterial and viral gastrointestinal infections, with a planned product launch aimed at broadening QIAGEN's syndromic testing capabilities in both inpatient and outpatient settings, enhancing its market presence in precision diagnostics
- In October 2024, Becton, Dickinson and Company (BD) obtained Health Canada approval for its Onclarity HPV Assay to be used with self-collected vaginal samples, enabling at-home human papillomavirus (HPV) testing, which improves accessibility to early cervical cancer screening solutions
- In June 2024, bioMérieux announced that its BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini received FDA Special 510(k) clearance and a CLIA waiver, offering a point-of-care multiplex PCR solution that can detect five common respiratory and sore throat pathogens in approximately 15 minutes using relevant swab samples, thus enhancing rapid diagnostic capabilities in clinical settings
- In January 2024, ELITechGroup expanded its in-vitro diagnostics portfolio by launching the CE-IVDR-certified GI bacterial PLUS ELITe MGB kit, capable of identifying bacterial pathogens linked to gastrointestinal infections, aiming to boost adoption of advanced diagnostics in GI testing
- In January 2024, HORIBA Medical introduced its CE-IVDR-certified 2.0 high-throughput automated hematology platform, engineered to deliver high-quality and scalable analytical performance for clinical laboratories, supporting improved efficiency and reliability in hematology testing
