Mycobacterium tuberculosis
The multi-year project led by FIND is currently evaluating three end-to-end solutions through clinical studies.
The firm has obtained CE marking for its automated, sample-to-answer Vidas TB-IGRA test for latent TB and is preparing a submission for FDA clearance.
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.
The WHO and FIND are supporting NGS-based testing in low-resource settings, while a resistance testing program at New York State's Wadsworth Center has matured.
Cepheid Debuts 10-Color Molecular Detection Technology With New Tuberculosis Test
The firm launched a CE-IVD marked test for extremely drug-resistant TB and expects to incorporate the multiplexing technology in other assays.