High-sensitivity troponin testing is enabling earlier detection of myocardial injury and supporting faster diagnostic pathways for patients with suspected heart attacks.
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 Galleri blood test demonstrated a four-fold increase in cancer detection rates and substantial reduction in stage IV cancer diagnoses in 142,000 participants.
The FDA has granted Breakthrough Device Designation to Breath Diagnostics Inc.'s OneBreath, a breath-based test that assesses postoperative pneumonia risk in cardiac surgery patients using a single preoperative sample.
The CDC has named Cepheid one of four national collaborators to accelerate rapid diagnostic assay development for public health emergencies under a new federal initiative and IDIQ contract.
HerAnova Lifesciences has launched HerResolve, the first blood-based test for endometriosis detection, at IVF centers nationwide. Validation studies show diagnostic accuracy comparable to surgical standards, according to the company.
Researchers at JAX and MIT have developed a microneedle patch that samples immune cells from skin within hours, providing a noninvasive alternative to blood draws and biopsies.
The test measures two sugar alcohols to detect SORD-related neuropathy, which standard genetic tests sometimes miss.
The test uses five biomarkers and proprietary technology to detect amyloid brain plaques in patients with cognitive symptoms.
Researchers at UC San Diego have developed the MAPI score, a blood test using five standard lab values to distinguish alcohol-related liver injury from metabolic causes, according to a study in Gastroenterology.
The agreement aims to improve early detection and management of chronic kidney disease in underserved populations through integrated diagnostics and digital health solutions.
The Cystic Fibrosis Base assay has received IVDR accreditation, ensuring high standards for detecting cystic fibrosis mutations.
Research in bone marrow transplant patients with blood cancers and febrile neutropenia suggests the host-response test may help identify infection in high-risk populations.