tuberculosis
The firm has obtained CE marking for its automated, sample-to-answer Vidas TB-IGRA test for latent TBÂ and is preparing a submission for FDA clearance.
WHO Updates Recommendations to Improve Access to Rapid MDx Tests for TB, Drug-Resistant TB
The WHO recommended moderate-complexity, automated nucleic acid amplification test for the initial detection of TB and resistance to rifampicin and isoniazid.
The test uses mass spectrometry to measure an M. tuberculosis peptide and could be used for diagnosing the disease and monitoring response to treatment.
The project, being coordinated by UCSF and the University of Heidelberg, has a total budget of $20 million and is expected to run through 2025.
BioMérieux Interferon Gamma Release Assay for Latent TB Gets CE Mark
The test is fully automated from sample to result interpretation and requires one whole-blood sample tube with no manual sample preparation necessary.