Molecular Detection Inc. Awarded $244,500 Federal Grant To Support US Validation Trial for Its Detect-Ready™ MRSA Screening Panel
11/3/2010 7:30:26 AM
WAYNE, Pa., Nov. 3, 2010 /PRNewswire/ -- Molecular Detection Inc. (MDI), a company developing Detect-Ready tests designed to increase the speed and accuracy of infectious disease diagnosis, today announced that it has been awarded a $244,500 federal Therapeutic Discovery Project grant. The grant is intended to support the US clinical development program for MDI's Detect-Ready panel that detects carriers of MRSA (methicillin-resistant S.Aureus) and related pathogens as part of hospital-based screening programs aimed at decreasing the high incidence and costs of MRSA infections.
MDI's Detect-Ready panel is a qualitative real-time PCR in vitro diagnostic test that is marketed in the European Union and Australia and is in late stage development in the US. Its CE-mark label in the EU was recently expanded to include the detection of colonization with MSSA (methicillin-sensitive S.Aureus) and other bacteria, in addition to MRSA. Detect-Ready is the only MRSA screening test with the capability to discriminate between these pathogens as a result of its proprietary differential diagnosis technology, which produces highly accurate data that minimize the false positive results experienced with other MRSA screening tests and ensure that clinicians have the timely and reliable information they need to assess patient risk at admission to the hospital or outpatient facility.
"The potential of our Detect-Ready MRSA panel to reduce healthcare costs while improving quality of care make it fitting that the U.S. Department of Health and Human Services selected our application for funding under this new program," said Todd Wallach, CEO and chairman of MDI.
Mr. Wallach added, "A growing body of independent data is confirming that our Detect-Ready panel, which is the first to include a range of clinical targets, is the most technically advanced MRSA screening test available today, and its initial acceptance by hospitals in Europe has been very encouraging. Plans for our 510(k) validation trial are progressing well, with clinical sites on board and needed approvals in place. These new federal funds will enable us to further accelerate the clinical program, with the goal of bringing the advantages of our Detect-Ready MRSA panel to the US healthcare system in 2011."
Detect-Ready kits are compatible with a number of the real time-PCR platforms currently found in most hospitals. They offer healthcare providers a high-performance "sample-to-answer" MRSA screening panel with an unmatched combination of accuracy, speed, flexibility and cost-effectiveness.
MRSA infections pose a growing problem to hospitals and health care facilities worldwide. The highly-contagious bacteria that cause MRSA infections are resistant to all but the most powerful antibiotics. The CDC estimates that in 2005, there were approximately 90,000 persons in the US diagnosed with severe MRSA infection and an estimated 19,000 died. The incidence of MRSA infections has been rising and some experts estimate that over 60% of hospital-acquired bacterial infections are now antibiotic-resistant.
The Qualifying Therapeutic Discovery Project, enacted as part of the federal Patient Protection and Affordable Care Act of 2010, is designed to provide grants or tax credits to qualified biotechnology companies that demonstrate the potential to produce a new diagnostic to prevent, detect or treat chronic or acute disease and conditions; reduce long-term health costs; or significantly advance the goal of curing cancer within a 30-year period.
The Detect-Ready MRSA panel is currently available in the UK, Germany, Ireland, Switzerland, Spain, Austria and Australia, with additional launches expected in the Netherlands, Belgium, Luxembourg and other territories in the coming months.
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 panel for hospital-based MRSA screening. These staph 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 panel provides increased accuracy, faster time to results and more efficient utilization of hospital resources compared to other MRSA diagnostic products. 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.
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