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Dx Focus: Quest Simplexa C. Diff Assay Gets FDA OK; XDx Begins AlloMap Testing in Germany


Quest Diagnostics said this week that the US Food and Drug Administration has granted 510(k) clearance for its Simplexa C. difficile Universal Direct Test on the 3M Integrated Cycler.

The test, from Quest's Focus Diagnostics business, is intended to aid in diagnosing Clostridium difficile-associated disease. The test is performed on liquid or unformed human stool samples and detects the C. difficile toxin B gene, including NAP1; and uses a proprietary chemistry that eliminates the need for nucleic acid extraction. The entire testing process can be completed in about an hour, Quest said.

All of Quest's Simplexa real-time PCR tests run on the 3M Integrated Cycler, which can process up to 94 patient specimens in about an hour.

Quest said that the Simplexa C. difficile Universal Direct Test is immediately available in the US. The company obtained CE marking for the assay and launched it in Europe last May (PCR Insider, 5/5/2011).

XDx said last week that it has launched AlloMap Molecular Expression Testing in Germany.

AlloMap is a non-invasive blood test that helps physicians to determine a stable heart transplant patient's risk of acute cellular rejection without using endomyocardial biopsy. The test uses quantitative real-time PCR to survey 20 genes — 11 of which are used to calculate the AlloMap Test score and 9 of which are used for standardization and quality control — using RNA isolated from peripheral blood mononuclear cells.

The test received a CE IVD mark in April 2011, and heart transplant specialists began using the assay in select German hospitals last month. XDx said that it now expects to make AlloMap available to additional German, Swiss, and Austrian transplant centers throughout the second quarter of this year in the first stage of a broader European launch.

AlloMap is cleared by the US Food and Drug Administration and has been available in the US since 2005.