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BioGx Lands CE Mark for Four Infectious Disease Tests

NEW YORK (GenomeWeb) – BioGx today announced that it has received CE-IVD marking for four real-time PCR-based tests for infectious disease.

The four tests that received the CE mark last week are: BioGx Mycoplasma-Ureaplasma, a test for diagnosing genital infection using ThinPrep or universal transport media samples; BioGx Pneumocystis jirovecii, a test for pneumonia caused by the eponymous fungus using pretreated sputum samples; BioGx Mycobacterium tuberculosis Complex, a tuberculosis infection using pretreated sputum and bronchoalveolar lavage samples; and BioGx Bordetella Speciation plus Toxin, a test for several Bordetella species using nasopharyngeal swabs or nasal wash samples.

"All tests are designed to run on the BD Max platform only, but the company is in discussions with other manufacturers of open [molecular diagnostic] platforms to develop test kits for their instruments," a BioGx spokesperson said in an email. Real-time PCR reagents for all tests are lyophilized into one tube.

The Birmingham, Alabama-based molecular diagnostics firm is launching the tests in Europe through a Netherlands-based subsidiary.

"These four tests are a few of many planned for launch on the BD Max and other fully automated platforms", BioGx CEO Shazi Iqbal said in a statement.

In October 2016, the firm received CE marking for real-time PCR-based Influenza A, Influenza B, and respiratory syncytial virus tests, also designed for the BD Max system.

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