Spotlight Medical’s myStage Dx AI breast cancer test has received CE marking under EU IVDR, enabling adoption in European oncology and pathology labs for recurrence risk assessment in ER+/HER2- early breast cancer patients.
The assay measures lipoprotein(a) levels in molar units to improve cardiovascular risk assessment and standardization across laboratories.
A new NIH-funded study finds that elevated circular RNAs in blood may predict Alzheimer’s symptoms years in advance, outperforming current blood tests in forecasting disease progression.
A blood test detecting circulating tumor DNA post-surgery can help identify colorectal cancer patients with liver metastases who are most likely to benefit from adjuvant chemotherapy, according to data from the Phase II GALAXY study.
IntelliGenome receives regulatory clearance and partners with Velez Lab for distribution of its molecular diagnostic assay.
The patent covers a gene-expression profiling method designed to identify patients most likely to respond to the investigational therapy stenoparib through 2042.
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.
The assay measures enzyme activity in plasma to help clinicians identify acute ischemic stroke, which is often missed by standard imaging.
Research indicates that blood and cerebrospinal fluid tests provide relevant prognostic information for elderly patients, challenging the idea that aging makes these tests less useful.
A two-year real-world study of Renalytix’s FDA-approved KidneyIntelX.dkd test showed improved kidney function and targeted treatment in 2,470 patients with type 2 diabetes.
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.