Quidel and Life Technologies Receive FDA Clearance for Clostridium Difficile Assay and QuantStudio™ DX and 7500 Fast DX Real-Time PCR Instruments
25 Mar 2013

Quidel Corporation and Life Technologies Corporation 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’ QuantStudioTM Dx and 7500 Fast Dx Applied Biosystems® Real-Time PCR Instruments.

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.

“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 $1 billion in excess treatment. For this reason, a fast and accurate diagnosis is vital to the patient’s proper treatment and speedy recovery,”1 said Douglas Bryant, 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 Ronnie Andrews, 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.

The Quidel Molecular Direct C. difficile 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,” said Andrews. “Life Technologies is committed to providing physicians and clinical laboratories with instrumentation designed for flexibility and ease of use, as well as best-in-class diagnostic tests where we see unmet clinical need.”

The QuantStudio™ Dx Real-Time PCR instrument’s touch screen, reagent and sample tracking, and LIMS (Laboratory Information Management Systems) interface are specifically designed for ease of use, and the six-color feature allows for a multiplex of six targets in one reaction.

The 7500 Fast Dx Real-time PCR Instrument system is a five-color real-time PCR instrument that delivers the performance required for high-quality results in a 96-well format. The 7500 Fast Dx is also FDA cleared for diagnostic use with the Center for Disease Control’s H1N1 assay and with the Quidel Molecular assays for Influenza A+B and human metapneumovirus (hMPV).

With the QuantStudio™ Dx, flexibility is enabled through an optional Test Development mode allowing the use of easily interchangeable thermal cycling blocks that accommodate 96- or 384-well plates and a proprietary qPCR microfluidics card, which can perform 48 tests on eight samples simultaneously without the need for liquid-handling robots. The card can also be used to design and implement custom tests. Life Technologies is currently developing diagnostic tests utilizing this format. In this Test Development mode, the QuantStudio™ Dx can perform numerous functions, including pathogen detection, gene expression analysis, SNP genotyping, copy number analysis, mutation detection, micro-RNA and other non-coding RNA analysis, and high-resolution melt analysis.

The current 510(k) clearance represents another milestone in the extension of Life Technologies’ move into the diagnostics arena. In September 2012, Life Technologies launched Pervenio™ Lung RS, a lab-developed test distinguishing high-risk from low-risk early stage lung cancer patients. In February 2013, the company received 510(k) clearance for its 3500 Dx Genetic Analyzers and SeCore® HLA typing kits.

The Quidel Molecular Direct C. difficile Assay is Quidel’s first assay with a streamlined stool processing procedure. Quidel also sells FDA approved molecular tests in the Real-Time PCR format for Influenza A+B, hMPV and RSV + hMPV.

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