The Bloodhound BCR::ABL1 assay simultaneously detects and quantifies all four clinically important isoforms in a single run, offering new capabilities for chronic myeloid leukemia management.
A peer-reviewed study in the Journal of Minimally Invasive Gynecology found HerAnova’s HerResolve blood assay detected 61.5% of endometriosis cases missed by imaging, with 97.5% specificity and 80% sensitivity.
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.
Thermo Fisher Scientific has opened an $18 million, 8,000-square-meter distribution and labeling center in Uppsala, Sweden, to support global supply of immunodiagnostics for allergy and autoimmune disease testing.
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.