Fujirebio Europe has received CE marking for its automated Lumipulse G pTau 217 Plasma assay, designed to help identify amyloid pathology in patients with cognitive decline, according to the company.
Bruker has launched the MyGenius PRO molecular diagnostics system in Europe, offering fully automated, high-throughput PCR testing for infectious diseases with an initial focus on CMV, EBV, and BKV assays for clinical labs.
As autoimmune and allergy test volumes rise, labs are prioritizing workflow standardization and structured testing pathways to ensure reliable results, according to Santhosh Nair, president of immunodiagnostics at Thermo Fisher Scientific.
ClearNote Health will present data at DDW 2026 showing its Avantect Pancreatic Cancer Test achieved 82.6% sensitivity and 97.5% specificity in patients at elevated risk.
A Boston University study found TB DNA in 12% to 16% of respiratory samples from hospitalized patients in a low-incidence area using an ultrasensitive assay, suggesting underdiagnosis of tuberculosis in the US.
Utepreva LLC has received FDA clearance for its single-use endometrial sampler, which employs three sampling mechanisms to improve tissue yield for cytologic and molecular analysis in early endometrial cancer detection.
The Elecsys NfL test measures a protein associated with nerve cell injury to monitor disease activity in patients with relapsing remitting multiple sclerosis.
The ACC, AHA, and nine other associations have issued an updated dyslipidemia guideline, recommending earlier intervention and expanded use of lipoprotein(a) and apolipoprotein B testing to improve cardiovascular risk assessment.
The study will analyze three key proteins to determine if blood-based biomarkers can provide an earlier and more accessible diagnostic method.
HistoIndex has partnered with Houston Research Institute and Knowledge Research Center to expand access to AI-driven digital pathology for liver disease diagnostics in Texas and California.
Insight Molecular Diagnostics has completed clinical validation and received ISO 13485 certification for its GraftAssureDx kidney transplant rejection test kit, moving toward FDA submission, according to the company.
The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.
A multicenter, vignette-based study found that adding a rapid sepsis test result to standard clinical data changed or reinforced diagnostic decisions in 86% of cases.