March 18, 2013
(NASDAQ: QDEL) and
Life Technologies Corporation
(NASDAQ: LIFE) announced today that they received 510(k) clearances from the United States Food and Drug Administration (FDA) to market the Quidel Molecular Direct C. difficile Assay with Life Technologies' QuantStudio
Dx and 7500 Fast Dx Applied Biosystems® Real-Time PCR Instruments.
bacterial infections are life-threatening, especially for the elderly, immunocompromised populations, and for patients on a prolonged antibiotic regimen.
infection (CDI) is frequently associated with antibiotic therapy and extended hospital stays.
"According to The Centers for Disease Control and Prevention (CDC), 14,000 deaths are attributed to CDI in the U.S. each year, which costs the national healthcare system about
in excess treatment. For this reason, a fast and accurate diagnosis is vital to the patient's proper treatment and speedy recovery,"
, president and chief executive officer for Quidel Corporation, who added, "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."
"Molecular diagnostic assays have become the gold standard for infectious disease testing in the clinical lab," said
, president of medical sciences at Life Technologies. "Molecular testing is the fastest-growing segment of the diagnostics market, and Life Technologies' deep expertise in real-time PCR instrumentation, together with our demonstrated effectiveness in pursuing regulatory pathways for our instruments, uniquely positions Life to become a leader in the diagnostics market."
This Quidel Molecular Direct C. difficile Assay is part of Quidel's expanding line of molecular diagnostics products. The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories, including Life Technologies' QuantStudio™ Dx and 7500 Fast Dx. These reagents provide attractive features that include refrigerated storage instead of freezing, convenient ready-to-use reagents, a short time to result, and other benefits that favorably enhance the molecular workflow.