Molecular Detection Inc.'s Detect-Ready(TM) MRSA Assay Demonstrates Strong Performance In Independent Comparative Study From Leading UK Hospital

WAYNE, Pa. and LIVERPOOL, England, Oct. 13 /PRNewswire/ -- Molecular Detection Inc. (MDI), a company developing Detect-Ready assays designed to increase the speed and accuracy of infectious disease diagnosis, today announced that its Detect-Ready MRSA assay has received its first independent validation in a study conducted at St. George’s Healthcare NHS Trust, a leading teaching hospital in the UK. The study results were presented this week at HIS 2010, the Seventh International Conference of the Hospital Infection Society(1).

In a comparative study of the Detect-Ready assay and two other widely used PCR-based MRSA screening tests, the St. George’s researchers confirmed that the performance of the Detect-Ready MRSA assay was better than or equivalent to Becton Dickinson‘s GeneOhm MRSA ACP Assay and Roche’s LightCycler® MRSA Advanced Test. Based on the results of this study, MDI’s Detect-Ready is now used as the molecular assay of choice in the MRSA screening programs at St George’s.

“Following this comparative study, St. George’s has adopted the Detect-Ready MRSA kit for routine MRSA screening in our intensive care unit (ICU), as a result of the high sensitivity and specificity we observed and the kits’ ease-of-use and cost-effectiveness,” said Dr. Cassie Pope, Clinical Scientist of St. George’s.

“The Detect-Ready MRSA kit provides a number of advantages, including software that provides non-subjective interpretation and straight-forward reporting. The inclusion of multiple gene targets in the Detect-Ready MRSA test appears to minimize false positive results, reducing both unnecessary resource deployment and the inconvenience to patients wrongly labeled as MRSA positive,” said Kay Capaldi, Chief Biomedical Scientist of St George’s.

“St. George’s is one of the most respected research hospitals in the UK, so we are especially pleased to receive their independent validation confirming the excellent sensitivity and specificity of our Detect-Ready MRSA assay,” said Todd Wallach, CEO of MDI. “We believe our Detect-Ready MRSA assay offers healthcare providers a high-performance MRSA screening test with an unmatched combination of accuracy, speed, flexibility and cost-effectiveness, and we look forward to the results of additional comparative studies currently underway.”

Drug-resistant, potentially deadly MRSA (methicillin-resistant Staphylococcus aureus) infections are a growing problem in healthcare facilities around the world. The Detect-Ready MRSA kit is a qualitative real-time PCR in vitro diagnostic test for the direct detection of MRSA nasal colonization to aid in the prevention and control of MRSA infections in hospitals and other healthcare settings. The proprietary technology in the Detect-Ready kits provides a unique differential diagnosis engine that produces highly accurate results, minimizing the false positives and false negatives experienced with other MRSA screening kits. Samples for testing are simple to obtain using nasal swabs and the assay’s ready-to-use pre-mixed reagents require only the addition of patient sample to run the test, which provides results in less than three hours.

Unlike other testing products that require special handling, Detect-Ready kits are off-the-shelf room temperature-stabilized and require no refrigeration. Detect-Ready kits are compatible with multiple rt-PCR platforms currently found in clinical laboratories, including the Roche LightCycler®, Qiagen Rotor-Gene® and Cepheid SmartCycler®. The flexibility to leverage existing infrastructure and equipment to run Detect-Ready assays eliminates the need for additional hospital capital investment.

The Detect-Ready MRSA assay kit has received the CE mark certification for sales in the European Union. It is distributed in the UK and Ireland by Launch Diagnostics. For more information, visit www.launchdiagnostics.com/bacteriology/MDIDetectReady.php.

The Detect-Ready MRSA assay is also currently available in Germany, Switzerland, Spain, Austria and Australia.

1. Pope CF, Capaldi K. Comparison of the analytical sensitivity of three commercial real time PCR assays for the detection of MRSA. Poster session presented at: Seventh International Conference of the Hospital Infection Society; 2010 Oct 10-13; Liverpool, UK.

About MRSA

Drug-resistant, potentially deadly MRSA (methicillin-resistant Staphylococcus aureus) infections are a growing problem in healthcare facilities around the world. Patients in hospitals are at increased risk for MRSA infection, which can be spread by medical personnel, medical instruments, or from exposure to bacteria on furniture or other surfaces. The routine invasive medical procedures performed in hospitals also create openings for MRSA to enter the bloodstream. The incidence of MRSA infections has been rising, and some experts estimate that over 60% of hospital-acquired S. aureus infections are now antibiotic-resistant. MRSA infections lead to increased disability and death among hospital patients, and also generate high costs for healthcare providers and for the healthcare system as a whole.

About HIS 2010

The Seventh International Conference of the Hospital Infection Society (HIS 2010) is being held in Liverpool, England from October 10-13, 2010. HIS is held every four years, and is internationally recognized as the most important infection prevention and control conference in Europe; it attracts leading world experts in healthcare-associated infections as speakers and delegates. For more information, visit: www.his2010.com.

About Molecular Detection

Molecular Detection Inc. (MDI), a US-based company with offices in Wayne, PA, Tunbridge Wells, UK and Jerusalem, Israel, is developing and commercializing a portfolio of “sample-to-answer” Detect-Ready molecular diagnostic tests for the detection of infectious diseases. The company’s first product is a ready-to-use, rapid detection DNA probe test for hospital-based MRSA screening. MRSA infections represent a growing problem to the healthcare system. Successful MRSA control efforts rely on screening potential carriers to prevent the spread of the disease. The Detect-Ready MRSA test provides increased accuracy, faster time to results and more efficient utilization of hospital resources compared to other MRSA diagnostic products. It is currently available in the UK, Germany, Ireland, Switzerland, Spain, Austria and Australia, with additional launches expected in the coming months. MDI’s real-time PCR tests are based on novel patent-pending technologies for differential diagnosis and room-temperature stabilization. For more information, visit www.detect-ready.com.

SOURCE Molecular Detection Inc.