Molecular Detection Inc. (MDI), a company developing Detect-Ready® assays designed to increase the speed and accuracy of infectious disease diagnosis, today announced that it has received a notice of allowance from the US Patent and Trademark Office (USPTO) for a patent application titled "Methods, Compositions and Kits for Detection and Analysis of Antibiotic Resistant Bacteria." The allowed claims cover a key aspect of MDI's PCR-based technology platform, which accurately distinguishes between samples containing MRSA (methicillin resistant Staphylococcus aureus), MSSA (methicillin sensitive S. aureus) and mixed populations of bacteria by amplifying and evaluating multiple gene targets.
"Allowance of these claims confirms that MDI's approach is indeed state-of-the-art," said Todd Wallach, CEO and chairman of MDI. "They add legal backing to a growing body of independent data confirming that our Detect-Ready panel is the most technically advanced MRSA screening test available today, and effectively raise the bar for other screening products. The allowance includes broad method and kit claims, and we expect that the issued patent will serve as a powerful resource in our drive to achieve leadership in the molecular detection of resistant pathogens, a large and growing healthcare problem worldwide."
MDI's first product, the Detect-Ready MRSA 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 was recently 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 false positive results experienced with other MRSA screening tests and ensuring that clinicians and healthcare facilities have the timely and reliable information they need to assess and minimize patient risk.
Mr. Wallach added, "We are especially pleased with the allowed claims in view of the fact that the FDA has issued draft guidelines for MRSA screening tests that require the discrimination and accuracy enabled by our proprietary technology. Plans for our US validation trial are progressing well, with US launch targeted for 2012."
Infections by MRSA and other antibiotic-resistant pathogens pose a growing problem to hospitals and healthcare facilities worldwide. The highly contagious bacteria that cause MRSA infections are resistant to all but the most powerful antibiotics. 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. 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 allowed patent application (Application No. 12/106,137) is expected to issue in the next few months.
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.