June 2026, bioMérieux submitted 510(k) applications for updated versions of its BIOFIRE FILMARRAY Gastrointestinal panels (GI1.1 and GI1.1 Mid), featuring enhanced norovirus detection and increased assay specificity for use on its Filmarray 2.0 and Torch systems — relevant given an estimated 1.7 billion cases of diarrheal disease occur globally each year, where fast pathogen identification directly supports infection prevention and control. (Source: biomerieux.com)
Q2 2024: Abbott launches new rapid COVID-19 and flu test in Europe Abbott announced the launch of a new rapid diagnostic test that simultaneously detects COVID-19 and influenza A/B in Europe, expanding its portfolio of point-of-care infectious disease diagnostics.
Q2 2024: QuidelOrtho Receives FDA Clearance for Sofia 2 SARS Antigen+ FIA Rapid Test QuidelOrtho received FDA clearance for its Sofia 2 SARS Antigen+ FIA, a rapid diagnostic test designed for point-of-care detection of SARS-CoV-2, further strengthening its U.S. diagnostics portfolio.
Q2 2024: BD Launches New Rapid Antimicrobial Susceptibility Test in Europe Becton, Dickinson and Company (BD) launched a new rapid antimicrobial susceptibility test in Europe, enabling clinicians to quickly determine the most effective antibiotics for patients with bloodstream infections.
Q2 2024: LumiraDx Announces CE Mark for New RSV Rapid Antigen Test LumiraDx received CE Mark approval for its new rapid antigen test for respiratory syncytial virus (RSV), allowing the company to market the test across the European Economic Area.
Q2 2024: Cue Health wins $28M contract from U.S. Department of Health and Human Services for rapid flu test Cue Health secured a $28 million contract from the U.S. Department of Health and Human Services to develop and supply a rapid flu diagnostic test for use in public health settings.
Q2 2024: Visby Medical raises $100M Series E to expand rapid diagnostics platform Visby Medical closed a $100 million Series E funding round to accelerate the development and commercialization of its rapid, single-use molecular diagnostic platform.
Q3 2024: Siemens Healthineers acquires rapid diagnostics startup CorDx for $350 million Siemens Healthineers announced the acquisition of CorDx, a U.S.-based rapid diagnostics company, for $350 million to strengthen its point-of-care testing capabilities.
Q3 2024: bioMérieux launches new rapid sepsis diagnostic test in the U.S. bioMérieux launched a new rapid diagnostic test for sepsis in the United States, aiming to improve early detection and treatment outcomes for critically ill patients.
Q3 2024: OraSure Technologies Appoints New CEO to Lead Rapid Diagnostics Market Growth OraSure Technologies announced the appointment of a new Chief Executive Officer, signaling a strategic focus on expanding its rapid diagnostics business.
Q3 2024: Ellume opens new U.S. manufacturing facility for rapid COVID-19 and flu tests Ellume inaugurated a new manufacturing facility in the United States dedicated to producing rapid COVID-19 and influenza diagnostic tests, increasing domestic supply capacity.
Q4 2024: Roche launches new rapid molecular test for sexually transmitted infections Roche introduced a new rapid molecular diagnostic test for sexually transmitted infections, expanding its portfolio of point-of-care solutions for infectious diseases.
Q1 2025: Abbott receives FDA approval for new rapid dengue test Abbott received FDA approval for its new rapid diagnostic test for dengue, enabling faster detection and management of the disease in endemic regions.