Co-Diagnostics has submitted a Dual 510(k) and CLIA waiver application to the FDA for its PCR-based flu and RSV test, aiming to enable point-of-care use on the Co-Dx PCR Pro instrument.
A Quest Diagnostics study of 1.5 million women found those with bacterial vaginosis are over three times more likely to have a non-viral STI, highlighting the need for comprehensive diagnostic testing.
As Cyclospora infections surge in the US, laboratories face increased pressure to quickly differentiate cases, with the CDC reporting 1,947 confirmed infections and 98 hospitalizations across nine states as of July 24.
Nabsys and Indiana University School of Medicine have launched a multi-year collaboration to develop electronic genome mapping applications for acute myeloid leukemia and myelodysplastic syndromes.
Seegene has introduced a syndromic PCR-based test for simultaneous detection of STIs and HPV. Company data show co-detection in 71% of positive cases, supporting potential clinical utility for comprehensive reproductive infection screening.
Researchers identified coordinated lipid, metabolite, and protein signatures in symptomatic patients, supporting a multi-omic strategy for earlier ovarian cancer detection.
A new ultrasensitive blood test may detect Sjögren’s disease more than 10 years before symptoms appear by identifying chronically elevated interferon alpha levels in patient blood samples.
The assay measures lipoprotein(a) levels in molar units to improve cardiovascular risk assessment and standardization across laboratories.
USC researchers report that two blood tests, Lumipulse G p-tau217/β-Amyloid 1-42 and PrecivityAD2, can accurately detect Alzheimer’s pathology in patients with Down syndrome.
Research presented at ADLM 2026 indicates immunoassays may significantly underestimate HbA1c in patients with sickle cell trait, suggesting HPLC offers more reliable diabetes screening for populations with hemoglobin variants.
Elevated donor-derived cell-free DNA levels are linked to higher kidney transplant failure risk, suggesting earlier detection of allograft injury before loss of kidney function.
The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.
The BD BACTEC FXI Culture System reduces detection time for bloodstream infections by approximately three hours compared to previous models.