Molecular Detection said this week that it has received a notice of allowance from the US Patent and Trademark Office for a patent covering a key aspect of the company's PCR-based test for detecting and distinguishing between methicillin-resistant and methicillin-sensitive Staphylococcus aureus.
Molecular Detection filed the patent application, No. 12/106,137 entitled "Methods, Compositions and Kits for Detection and Analysis of Antibiotic Resistant Bacteria," in March 2009. The company said that the patent is expected to issue sometime in the next few months.
The company's test, called Detect-Ready, uses real-time PCR to amplify and evaluate multiple gene targets to detect and distinguish between samples containing MRSA, MSSA, and mixed populations of bacteria. The kits are compatible with a number of real time-PCR platforms, the company said.
In collaboration with various distributors, the company markets the test in the European Union and Australia; and the test is in late-stage development in the US, the company said. Its CE-mark label was recently expanded to include the detection of colonization with MSSA and other bacteria, in addition to MRSA.
According to Molecular Detection, Detect-Ready is the only marketed PCR-based MRSA screening test that can accurately discriminate between MRSA and MSSA, thereby minimizing false positive results experienced with other MRSA screening tests.
"We are especially pleased with the allowed claims in view of the fact that the [US Food and Drug Administration] has issued draft guidelines for MRSA screening tests that require the discrimination and accuracy enabled by our proprietary technology," Todd Wallach, CEO and chairman of MDI, said in a statement.
In its draft guidance on culture-based MRSA tests, released last month, the FDA recommended that devices that detect both MRSA and MSSA have sensitivity/specificity for both bacteria of "at least 95 percent with a lower 95 percent (two-sided) confidence bound exceeding 90 percent."
Wallach added that plans for the company's US validation trial "are progressing well, with US launch targeted for 2012."