MDI’s Detect-Ready™

MDI’s Detect-Ready™

MDI’s Detect-Ready™ molecular diagnostic tests represent a major breakthrough in real time (rt) PCR testing. rt-PCR testing offers accurate detection of pathogens at extremely low target concentrations in samples, but more widespread use has been restricted by the many practical problems it entails, including the need for cold storage and highly skilled technicians to prepare reagents on a daily basis. Detect-Ready technology dramatically simplifies the use of rt-PCR tests. Detect-Ready assays are based on MDI’s novel proprietary technology platform that does not require daily test preparation and allows for true off-the-shelf room temperature storage of all of the components of the reaction mixture.

Most importantly, the Detect-Ready multiplex technology enables higher accuracy. Clinical testing of the Detect-Ready MRSA assay demonstrated high rates of sensitivity and specificity, with a marked reduction in the rates of false positive and false negative results experienced with other rt-PCR MRSA tests on the market. The high level of accuracy is made possible by MDI’s proprietary differential diagnosis engine, which distinguishes between pathogens by assessing multiple DNA targets and genetic markers to determine if MRSA is present.

MDI’s technology platform is compatible with a number of common rt-PCR instruments, allowing Detect-Ready molecular detection tests to be easily adapted to run on standard rt-PCR instruments already present in most laboratories.

MDI’s Detect-Ready technology is being incorporated into a portfolio of diagnostic test kits for a number of infectious diseases.

Pipeline

MDI is developing a pipeline of Detect-Ready™ molecular detection kits for a number of indications. The first product-the Detect-Ready™ MRSA assay, an rt-PCR-based diagnostic test for detecting MRSA carriers using nasal samples, is available in several countries in the European Union. U.S. regulatory. MDI is also developing kits for the detection of bloodstream MRSA infection and bloodstream VRE (vancomycin resistant enterococcus) infection. In addition, MDI’s Detect-Ready™ tests are being developed to detect the presence of other microbial agents, including C. difficile, a bacteria strain that can cause severe colitis and diarrhea; sexually transmitted diseases; cytomegalovirus (CMV), a common virus that can cause serious diseases when transmitted to unborn babies and people with compromised immune systems; and foodborne pathogens.