Cardiovascular Disease
News on molecular diagnostics, pharmacogenomics tests for coronary artery disease, congenital heart defects, and more.
Roche Lipoprotein (a) Test Receives FDA 510(k) Clearance
The test, which is intended for assessing cardiovascular risk, is the first lipoprotein (a), or Lp(a), test measured in nanomoles per liter to receive FDA clearance.
Abbott Nabs FDA Clearance for Cardiac Function Test
The clinical chemistry test is intended to help diagnose heart failure using the N-terminal pro B-type natriuretic peptide biomarker.
BioMérieux Acquires Norway's SpinChip Diagnostics for €138M
The rapid spinning disk-based immunoassay technology will enhance BioMérieux's offering at the point of care, the firm said.
Cardio Diagnostics AI-Based Tests Receive Final CMS Pricing Determination
The company's two tests will be gapfilled, meaning that Medicare contractors will determine pricing for the assays based on the firm's actual cost data.
Biobanks have been making strides in gathering data from more diverse populations this year while the evidence for the clinical utility of embryo PRS testing remains insufficient.