The trial, part of a multiyear effort to standardize HbA1c testing in labs, will be repeated annually with more labs participating and more countries represented.
The expanded clearance includes use of the test to assess a patient's risk of developing diabetes. The assay was cleared to run on the Afinion AS100 Analyzer.
Clinicians are using Roche's Cobas Omni Utility Channel to run lab-developed PCR tests alongside in vitro diagnostic kits, freeing valuable resources for labs.
Color announced it's offer $50 confirmatory testing for individuals who have positive results from 23andMe’s direct-to-consumer genetic test that gauges three BRCA1 and BRCA2 mutations
Alere received clearance for the Afinion HbA1c Dx and for the Alere i Strep A 2, a rapid molecular test for the qualitative detection of Streptococcus pyogenes.
At least one HIV self-test from a competitor could reach the global market this year. In addition, the company is in the midst of a strategic review.
The study found that central laboratory troponin and chemistry testing dropped by half, and POC testing improved care.
The newly independent firm will continue to invest in diagnostics by bringing its menu of PCR tests for infectious diseases to the US and other markets, among other objectives.
Sanquin provided input to the design of Abbott's next-generation Alinity s system and served as a clinical testing site during the development process.
The company unveiled forthcoming products for high-throughput molecular testing, diagnostic lab informatics, and microbiology automation.