NEW YORK (GenomeWeb News) – For the past eight years Menon Biosensors has operated in near secrecy developing a technology with US government backing to detect some of the world's deadliest biothreat pathogens.
Now, the San Diego-based firm is preparing to use that same technology to change the healthcare market.
Menon has developed both an instrument and assays to run on its platform and is seeking a partner to build the front end to the instrument. It doesn't expect to have any products commercially available for another two or three years, but when it does, the company's Chairman David Schlotterbeck said, the instrument could change disease detection and diagnosis in a manner similar to PCR's effect on the diagnostics market.
"This is the same kind of platform technology as PCR, except that it's a lot simpler, it's a lot faster, it's a lot less expensive," Schlotterbeck told GenomeWeb Daily News in January on the sidelines of the 32nd Annual JP Morgan Healthcare Conference in San Francisco.
In addition to the biothreat and molecular diagnostic spaces, the technology — which the company calls Menon Molecular Mirroring Technology (M2) and is based on nuclear magnetic resonance to detect molecular and immunochemistry biomarkers — has applications in food and water safety, as well as veterinary medicine, Schlotterbeck said. For now, though, Menon's focus is on healthcare.
The company has developed two assays, one for active tuberculosis and for Clostridium difficile, and earlier this month, it announced that the technology successfully detected Mycobacterium tuberculosis and C. difficile in studies using more than 500 samples and in concentrations as low as one colony-forming unit (CFU) per sample. And it did so with no false positives or false negatives, Menon said.
The TB assay, said Schlotterbeck, the former Chairman and CEO of Care Fusion and Aperio Technologies, is 25 times more sensitive than Cepheid's test, which he called "the closest competitor that is already on the market."
The assay is now moving into clinical validation with John Spinosa, an anatomic and clinical pathologist at Scripps Health in La Jolla, Calif., supervising the data generation. Results from the clinical validation could come as soon as within the next 60 to 90 days, Schlotterbeck said.
Menon also is working with a "world-renowned expert," whom Schlotterbeck declined to name, to clinically validate its C. difficile assay, and results from that effort could also come within the next 60 to 90 days.
The M2 technology was developed as part of a classified program with the US Department of Defense and Department of Homeland Security that started in 2005, and which was declassified during the summer of 2012.
Menon was founded in 2000 by its parent firm Menon International to focus specifically on its NMR-based technology, and to date, $20 million has been invested into developing it. The largest investors in the firm are the firm's CEO Suresh Menon, Schlotterbeck, and angel investors.
As part of its work for DoD and DHS, Menon demonstrated the ability of the platform to detect multiple organisms simultaneously, including the bacteria Bacillus anthracis; Staphylococcus aureus; Vibrio cholera; as well as Avian influenza virus strains. In all, it has developed 35 assays targeting biothreats, "many of which have been completely validated" by DoD and DHS, Schlotterbeck said.
During the summer, Menon made the decision to develop the assays for TB and C. difficile, positioning it for entry into the MDx market.
The underlying technology of the platform was validated by the US government using 3,000 samples with interferents and strains that are genetically close to the targeted pathogens — dubbed near neighbors — with no false negatives or false positives, Schlotterbeck said.
"The bottom line is it can't be fooled," he said.
In December, Menon announced that the technology was able to detect the presence of Yersinia pestis, or the plague, in water, air, blood, sputum, urine, and stool in concentrations as low as one CFU per sample and again without any false negatives or false positives.
According to Menon, the technology works by binding nanoparticles to probes, which, in turn, bind to a target biomarker. The nanoparticles "vary the relaxation parameters when a magnetic field pulses through a sample volume," and within a dynamic range that can be varied. What results is a score that quantifies the presence of the biomarker.
The technology, the company added, can detect one binding event in complex matrices with pollutants.
Tweaking the technology for use for MDx purposes from its current use for biothreat detection, Schlotterbeck added, is "amazingly simple," and involves changes to temperatures at which sample conditioning is done, as well as the amount of time needed for the changes.
"And that's it," he said. "What makes it a platform technology are small tweaks to ready it for a whole new application. There's no major redesign that had to be done at all."
About the size of a thick briefcase, M2 operates on AA batteries and readouts are displayed on a tablet such as an iPAD. Portable enough to be used in the field as well as in a centralized laboratory environment, it can return results from a sample in about one hour.
What's currently missing is push-button simplicity, Schlotterbeck said, and Menon is seeking a partner to develop that and to commercialize the technology. The firm is interviewing the "top 12 [molecular] diagnostic companies in the world" for a potential partnership, he said, mentioning Roche, Thermo Fisher Scientific, Illumina, and PerkinElmer among those with whom Menon has spoken or will speak. An announcement on the selection of a partner could come in six to nine months.
Whomever Menon chooses, the partner would design the front-end of the system, including automated sampling conditioning. It also would design a cartridge for the system, manufacture the platform, and bring the instrument through clinical trials and the regulatory approval process.
Menon would transfer the IP for the technology and continue to develop and extend the technology, as well as develop and supply the assays to the partner. The company owns the technology and its underlying IP, Gregory Hanson, a member of the company's financial advisory board, said.
A reason Menon chose TB as a target for an initial assay is that the disease remains a global epidemic without a quick and inexpensive point-of-care detection method, Schlotterbeck.
Menon's assays, he added, will cost pennies and the total cost of running a test in the field could be less than the $10 threshold that the World Health Organization has targeted for global testing, or about the cost at which Cepheid offers its Xpert MTB/RIF test in resource-poor areas of the world with multi-drug-resistant tuberculosis as part of its High-Burden Developing Country program.
Schlotterbeck noted that Cepheid's price is made possible through subsidies from various organizations, including the US President's Emergency Plan for AIDS Relief, the US Agency for International Development, and the Bill and Melinda Gates Foundation. Menon's tests, he said, would not require any financial support.
Of the C. difficile assay, Schlotterbeck said that "with proper tuning of the probes and other parameters," the assay can be made qualitative and "you can tell exactly how many CFUs you have."
Beyond TB and C. difficile, Menon plans on developing assays for other infectious diseases, he added.
In a statement last month announcing the results for the plague testing, Scripp's Spinosa said, "Having reviewed the new diagnostic technology, process, and assay data generated using Menon Biosensors' technology in identifying several well-known pathogens, I believe this technology provides a foundation to achieve a more facile, next-generation DNA diagnostic platform."
He added that Menon's platform has "significant implications in molecular biochemistry diagnostic applications for improving patient care and outcomes in an affordable and streamlined manner."