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Abbott Receives CE Mark for TB MDx

NEW YORK (GenomeWeb) – Abbott announced on Wednesday it received CE marking for a new molecular diagnostic test for detecting Mycobacterium tuberculosis.

The new test runs on Abbott's m2000 molecular diagnostic platform, and can be consolidated with the company's HIV-1 detection assay. An MTB inactivation step is included with the MTB test procedure to reduce the risk of airborne infection during the handing of sample material, Abbott said.

The World Health Organization estimates that in 2012, there were 8.6 million people globally who developed TB. Of these, 1.1 million were also HIV-positive, and a molecular diagnostic is needed by clinicians to prevent the transmission of TB and HIV, said Gavin Cloherty, director of global scientific affairs, infectious diseases, and molecular diagnostics for Abbott.

"TB is curable and with expanded access to molecular diagnostics technologies there is great potential to save lives in resource-limited areas," he said in a statement. Abbott noted that 75 percent of TB-HIV infections occur in high-burden areas, such as Africa.