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Vela Diagnostics

Great Basin said this week that it has submitted a 510(k) application to the US Food and Drug Administration for its molecular diagnostic test for Clostridium difficile.

By a GenomeWeb staff reporter
NEW YORK (GenomeWeb News) – Great Basin today announced it has filed for 510(k) clearance of its molecular diagnostic test for Clostridium difficile.

The company said that it has achieved encouraging results in a preclinical study of the assay, and that if clinical trial results are equally positive it will submit the test for US Food and Drug Administration approval by the end of the summer.

The company has developed a cartridge-based, multiplex, sample-to-answer molecular testing platform in the same vein as Cepheid, and hopes to begin clinical trials for its first two tests for detecting Staphylococcus aureus in blood culture and Clostridium difficile in stool by early summer.

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