While headlines tell of large divestitures, with diagnostic companies selling off noncore or underperforming business lines, some companies are boldly expanding their assay portfolios into clinical diagnostics. DTET has studied the business cases of two diagnostics start-ups that have plans to adapt their platform outside of their core business and move into clinical diagnostics and health care. Invisible Sentinel (Philadelphia), established itself in 2006 by enhancing food safety testing with its rapid molecular diagnostics. As of late March, the Association of Analytical Communities, the global standardization organization for the food industry, certified Sentinel’s Veriflow assays for salmonella, listeria, and campylobacter. The Veriflow platform uses vertical flow technology to enable testing in food products and various surfaces in contact with food during preparation and packaging. The food industry, a $1 billion testing market, provided an “interesting opportunity to bring the power of molecular diagnostics—its sensitivity and its accuracy—but to make it more accessible,” says Benjamin Pascal, co-founder and chief business officer of Invisible Sentinel. “Veriflow makes molecular diagnostics accessible with easy-to-read results, and it eliminates the need for capital equipment and maintenance so that it empowers the bulk of the food industry.” The pressing need for improved testing to ensure food […]
While headlines tell of large divestitures, with diagnostic companies selling off noncore or underperforming business lines, some companies are boldly expanding their assay portfolios into clinical diagnostics. DTET has studied the business cases of two diagnostics start-ups that have plans to adapt their platform outside of their core business and move into clinical diagnostics and health care.
Invisible Sentinel (Philadelphia), established itself in 2006 by enhancing food safety testing with its rapid molecular diagnostics. As of late March, the Association of Analytical Communities, the global standardization organization for the food industry, certified Sentinel’s Veriflow assays for salmonella, listeria, and campylobacter. The Veriflow platform uses vertical flow technology to enable testing in food products and various surfaces in contact with food during preparation and packaging.
The food industry, a $1 billion testing market, provided an “interesting opportunity to bring the power of molecular diagnostics—its sensitivity and its accuracy—but to make it more accessible,” says Benjamin Pascal, co-founder and chief business officer of Invisible Sentinel. “Veriflow makes molecular diagnostics accessible with easy-to-read results, and it eliminates the need for capital equipment and maintenance so that it empowers the bulk of the food industry.”
The pressing need for improved testing to ensure food safety, combined with a simpler path to regulatory approval, made the food and beverage industry Sentinel’s first choice. However, clinical molecular diagnostics was always a consideration given the founders’ experiences in the health care industry. The amount of capital needed for U.S. Food and Drug Administration regulatory approval was initially daunting, though. Now with steady revenue from food and beverage products, the company is looking to expand its Veriflow product portfolio across additional industries through partnerships established in a custom-solution program.
The company says that its patented vertical flow technology allows for the sensitivity of real-time polymerase chain reaction tests but with the ease of use of lateral flow assays. The system minimizes sample preparation (by eliminating the need for gel electrophoresis or fluorophore-based detection of target amplification), speeds time to results, and provides easy-to-interpret data for the end user. New, validated prototypes can be turned around in 12 weeks, Pascal tells DTET.
Another company that is rapidly validating clinical assays is Menon Biosensors (San Diego). Its Molecular Mirroring (M2) platform is based on nuclear magnetic resonance technology but was originally developed as a classified government project for the detection of agents that could be used in a bioterrorism attack, such as anthrax and the plague. Over a six-year period, more than 3,000 samples studied with the Department of Homeland Security’s Detect to Protect bio detection project, the platform demonstrated better than 99 percent accuracy.
Now the company has expanded the applicability of its portfolio of assays for pathogen detection, including Clostridium difficile (C. diff) and the mycobacterium tuberculosis complex and plans to add HIV and hepatitis C, as well as applications in food safety and livestock screening. Development of clinical assays for the health care industry began in mid-2013, and the company believes they have already achieved “a multiple level of improvement over current industry standards,” said Suresh Menon, Ph.D., the president of Menon Biosensors, in a statement.
Based on validation studies that are currently under way at Scripps Memorial Hospital laboratories, the company says the M2 technology has shown a “wide dynamic range” for pathogen detection (1 colony-forming unit [CFU] to 100 million CFU per sample). M2 was able to detect tuberculosis and C. diff in concentrations of 1 CFU per sample in water and 50 CFU/mL to 100 CFU/mL in sputum and stool. Sample prep took between five minutes and 15 minutes, with results within one hour. The company says they will further optimize assays for sputum and stool samples and will publish clinical validation data in 2014.
The platform may have applications in low-resource areas as well, as the platform requires less than 10 watts of electricity or a battery and the system weighs less than 10 pounds. Additionally, the reagents are lyophilized, allowing for storage at room temperature for one year. Results are displayed on a tablet.
Takeaway: Despite the trend toward divestitures of noncore business lines, some diagnostics companies are investing in expanding their platforms to address unmet needs in clinical diagnostics.
