NEW YORK – BioMérieux announced Tuesday evening that its Vidas TB-IGRA (interferon gamma release assay) has been CE marked for the diagnosis of latent TB infection.
The fully automated assay is to help in the diagnosis of Mycobacterium tuberculosis infection and is for use on BioMérieux's Vidas 3 platform. The test is fully automated from sample to result interpretation and requires one whole-blood sample tube with no manual sample preparation necessary, the Marcy L'Etoile, France-based company said.
It added that in clinical trials performed on people from four different parts of the world, the test demonstrated sensitivity in an active TB population of 97 percent compared to 80.6 percent with another unnamed existing test, as well as a specificity of 97.5 percent in populations with a very low risk of contracting TB.
It also demonstrated strong agreement with a comparative assay on populations at mixed risk levels of TB infection, and displayed a lower percentage of indeterminate results, 0.1 percent vs. 1.3 percent.
Other firms offering IGRAs for latent TB infection include Qiagen and Oxford Immunotec, now part of PerkinElmer.
BioMérieux said Vidas TB-IGRA will be gradually made available to geographies accepting the CE designation, and it plans to submit the test to the US Food and Drug Administration for clearance in the near future.
"Despite all efforts, tuberculosis has not been eradicated and remains a significant health problem for a large proportion of the world's population, especially in low- and middle-income countries," BioMérieux EVP and CMO Mark Miller said in a statement. "Diagnosing people who have latent TB infection is an important tool for global TB control. Detecting and then following or treating people with latent TB infection can help in preventing their progression to active disease, which would make them sick and also infectious to others."