Menon Biosensors, Inc. a molecular biochemistry company providing DNA analysis for the diagnosis and treatment of biological pathogens, announced today that its M2 (Molecular Mirroring) NMR (nuclear magnetic resonance) technology successfully demonstrated quantification of pathogens having concentrations ranging from 1 CFU to 100 million CFU per sample.
The study results represent eight orders of magnitude in dynamic range. Sample to answer continues to take less than one hour, as with the company's other reported study results for detection of Clostridium difficile (C. difficile), Mycobacterium tuberculosis complex (TB), Anthrax (Bacillus anthracis) and Plague (Yersinia pestis) in concentrations as low as 1 CFU per sample in several specimen types.
"Using the unique platform detection technology of M2, our scientists were able to develop a novel amplification approach, combined with random sample access to achieve quantification of eight orders of magnitude in dynamic range. This method is applicable to quantify both bacteria and viruses while delivering unmatched sensitivity," stated Suresh Menon, Ph.D., President of Menon Biosensors. "Sample to result remains less than one hour. We will continue to demonstrate the wide dynamic range particularly for HIV and Hepatitis C, in addition to pathogens infecting immunocompromised hosts. This dynamic range and sensitivity has applications in food safety, biodefense and livestock screening, where timely detection and quantification are often very useful."
Continued Dr. Menon, "Menon began developing and testing assays for the healthcare industry in mid-2013, and we have since achieved a multiple level of improvement over current industry standards. Detection and quantification of pathogens across a wide dynamic range in under one hour provides healthcare providers with critical information currently lacking in delivering quality, effective care. Rapid determination of the "pathogen load", particularly for viruses, gives physicians the ability to accurately and timely diagnose infections, select the most effective treatment, assess disease progression, and monitor response to therapy. Since 2005, Menon has developed and tested 35 bacterial and virus assays. We intend to expand our portfolio of assays and the dynamic range of M2 technology in the coming months."
Menon Biosensors will release the quantitative data to the largest prospective diagnostics company partners in the coming weeks, showing detection of Yersinia pestis from 1 CFU to 100 million CFU per sample. The data represent a monotonically increasing sequence as a function of various parameters used in M2 technology to detect and quantify the pathogen.
About Menon Biosensors' Platform Technology
M2 technology was developed initially to establish rapid countermeasures against bioterrorism.
Menon's technology provides superior results that enable officials to make intelligent, quick decisions following detection and exposure to lethal bacterial agents such as Anthrax (Bacillus anthracis) and Plague (Yersinia pestis). Testing of Menon's biosensor technology to detect against bioterrorist attack became public information in a press release by the Department of Homeland Security in August 2012.
Menon Biosensors' M2 technology has been validated through multiple studies with the U.S. government's Biodefense Programs. In these studies, conducted with more than 3,000 samples over a six-year period, the technology demonstrated greater than 99 percent accuracy in the presence of interferants and near neighbors of the pathogens to be detected.
Providing accurate results in less than one hour from the time a sample is collected, Menon Biosensors' M2 technology will allow medical professionals to quickly treat a pathogen with the appropriate therapeutic. Current diagnostic techniques for many pathogens can require several hours to multiple days for accurate detection, which limits treatment options early in the patient's care. The M2 technology also serves the need for diagnosis in food safety/livestock applications.
Menon Biosensor' platform technology is portable and offers random access testing with no cold chain requirements for the assays.
About Menon Biosensors, Inc.
Menon Biosensors is a molecular biochemistry company that provides DNA analysis for the diagnosis of biological pathogens. Menon Biosensors' microfluidics and M2 NMR platform technology (classified by the U.S. Government until 2012) provides superior sensitivity and specificity and minimizes sample preparation, providing best in class sample-to-answer pathogen detection. The technology has been validated by respected third parties in more than 3,000 samples over six years.