QuidelLifeQuidel Corp, San Diego, and Life Technologies Corp, Carlsbad, Calif, have received received FDA 510(k) clearances to offer the Quidel Molecular Direct C. difficile Assay with Life Technologies’ QuantStudioDx and 7500 Fast Dx Applied Biosystems® Real-Time PCR Instruments.

The Centers for Disease Control and Prevention (CDC) report that 14,000 deaths are attributed to C. difficile infection in the United States each year, costing the national health care system about $1 billion in excess treatment, says  Douglas Bryant, president and CEO, Quidel Corp, adding that a fast and accurate diagnosis is vital to a patient’s proper treatment and speedy recovery.1

“With the clearance of our C. difficile assay, we extend our Quidel Molecular product line beyond respiratory infections with products that address the needs of hospital laboratories in higher-volume settings,” Bryant says.

“Molecular diagnostic assays have become the gold standard for infectious disease testing in the clinical lab,” says Ronnie Andrews, president of medical sciences, Life Technologies, who notes that molecular  testing is the fastest-growing segment of the diagnostics market.

Clostridium difficile bacterial infections are life-threatening, especially for the elderly, immunocompromised populations, and for patients on a prolonged antibiotic regimen. C. difficile infection (CDI) is frequently associated with antibiotic therapy and extended hospital stays.

The assay kit includes an extraction-free, three-step sample preparation process that requires no heat step, no timed step, and no centrifugation as an added benefit. This fast and easy direct-to-amplification procedure allows the assay to generate a result in less than 70 minutes by an efficient and economical method.

“Combining multiple system capabilities in a single footprint, the QuantStudio Dx is our flagship instrument in the diagnostic lab market,” Andrews says.

The Quidel Molecular Direct C. difficile Assay is Quidel’s first assay with a streamlined stool-processing procedure.

1. http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6109a3.htm?s_cid=mm6109a3_w

[Source: Life Technologies]