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Dx Focus: Great Basin Files for 510(k) for C. diff Test; CE Mark for Focus's Simplexa CMV


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.

The company kicked off a clinical trial for the test in June, and initially planned for file for FDA clearance by the end of the summer (PCR Insider 6/30/2011)

Ryan Ashton, CEO and president of Great Basin, said in a statement this week that the trial results "exceeded our sensitivity and specificity performance targets" and that the company believes "the accuracy and workflow of the test will make it especially competitive in the marketplace."

He added that the results of the trial "are informing our work as we prepare additional assays … for clinical trial in the first half of 2012." These assays would focus on "virulent" healthcare-acquired infections such as fungal pathogens and methicillin-resistant Staphylococcus aureus.

The company's technology features an integrated disposable cartridge "containing all necessary reagents" and an inexpensive benchtop analyzer that executes the assay, interprets the results and provides a report for the clinician. Great Basin said that the system can provide results in under an hour with "no more than two to three hands-on steps."

The system can also multiplex up to 64 targets in a single assay, the company said.

Focus Diagnostics, a Quest Diagnostics business, said this week that it has CE Marked its Simplexa Cytomegalovirus molecular test kit on the 3M Integrated Cycler, which allows it to distribute the test to approximately 35 countries in Europe.

The test allows hospital labs to detect cytomegalovirus, a potentially fatal viral infection in immunocompromised patients with compromised immunity.

The Simplexa CMV test uses real-time PCR to quantitatively detect CMV in whole blood specimens and plasma.