Molecular Detection Inc. (MDI), which develops and markets Detect-Ready® assays designed to increase the speed and accuracy of infectious disease diagnosis, today announced major patent advances in the US and Europe. A second core US patent has issued covering key aspects of MDI's technology platform that assesses multiple gene targets to accurately distinguish between samples containing antibiotic-sensitive and antibiotic-resistant bacteria. Additionally, the company has received a notice of acceptance from the European Patent Office for an analogous patent application in Europe.
The US Patent and Trademark Office issued US Patent No. 8362228, "Methods, Compositions and Kits for Detection and Analysis of Antibiotic-Resistant Bacteria," on January 29, 2013. This is the second US patent in this area awarded to MDI, following on and expanding US Patent No.8,017,337. The accepted European application (European Patent Application No. 08799821.7) is expected to issue in the coming months.
MDI's Detect-Ready MRSA assay has the unique capability to distinguish between MRSA (methicillin-resistant Staphylococcus aureus), MSSA (methicillin-sensitive S. aureus) and mixed populations of bacteria by amplifying and evaluating multiple gene targets. MDI has also demonstrated the ability of the Detect-Ready technology to distinguish between antibiotic-sensitive and antibiotic-resistant strains in other bacterial pathogens. The company is developing a number of assays for these pathogens, such as a test for the early detection of resistant infections associated with sepsis.
"These patent advances in the US and Europe further confirm the advantages of MDI's approach," said Todd Wallach , CEO and chairman of MDI. "They reinforce the growing body of data showing that our Detect-Ready panel is the most technically advanced screening test available today for MRSA and antibiotic resistance. We believe that these patents, which include broad method and kit claims, reinforce our leadership position in the molecular detection of antibiotic-resistant and sensitive pathogens, a large and growing healthcare concern worldwide."
An article on antibiotic resistance in the January 24, 2013 edition of the New England Journal of Medicine notes that the recent annual report on global risks from the World Economic Forum concludes that "arguably the greatest risk…to human health comes in the form of antibiotic-resistant bacteria." Antibiotic-resistant pathogens such as MRSA pose a growing problem to hospitals and healthcare facilities worldwide. For example, the Centers for Disease Control (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.
MDI's Detect-Ready MRSA Panel is a qualitative, real-time PCR in vitro diagnostic test that is marketed in the European Union, Australia and Israel and is in late-stage development in the US. Its CE-mark label has been expanded to include the detection of colonization with MSSA and other bacteria, in addition to MRSA. Detect-Ready is the only marketed PCR-based MRSA screening test with the proven ability to accurately discriminate between these pathogens, thereby minimizing the potential for false positive results experienced with other MRSA screening tests and providing clinicians and healthcare facilities with the reliable information they need to assess and minimize patient risk.
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.
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, a ready-to-use, rapid detection panel for hospital-based MRSA screening, is currently commercially available in the EU and Australia. MRSA infections represent a growing problem to the healthcare system, and successful MRSA control efforts include the screening of individuals who may be 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, patented technologies for differential diagnosis and room-temperature stabilization.