Huntsville, AL  (October 19)  – GeneCapture, a company developing products for commercial and government applications for point of care diagnostics, announced today the world’s first multi-pathogen identification using non-amplified RNA detection. Its 1 hour ‘sample to answer’ CAPTURE PLATFORM™ is on track for commercialization within two years.

“We made history today – this is the first time an automated rapid pathogen identification has been reported directly from the sample, with no modification or amplification of its genetic source, in about an hour,” said GeneCapture CEO Peggy Sammon. “We envision a future where finding out why you are sick can be solved almost anywhere, in an hour, and without being chained to a lab. Infection detection will soon be portable, fast, and inexpensive. Just as the shift from relying on central computers to desktop and handheld devices enabled entirely new markets, so will decentralized, portable multi-pathogen infection detection.”

GeneCapture’s unique disposable cartridge enables its point of care vision for rapid, inexpensive multi-pathogen identification. Whether the illness is bacterial, viral, fungal or protozoan, a single test will pinpoint the cause. The novel technology consolidates sample prep and molecular signature detection in one plastic cartridge with a ‘one button’ portable reader.

Rick Myers, PhD, President, Science Director and M. A. Loya Chair in Genomics at HudsonAlpha says, “GeneCapture’s approach, an array-based genetic fingerprint based on direct RNA hybridization, is an innovative way to simplify the process and cost of responding to infections. Their recent demonstration of Sample-to-Answer pathogen identification is a major milestone for this industry.”  

The significance of a non-amplified solution is in the logistics. Without a need for enzymes, the test cost and complexity drop dramatically, allowing non-medical personnel to perform multi-pathogen tests without access to a lab. This ease of use will open up new markets for infection detection at schools, day care centers, clinics, veterinary offices, nursing homes, airports and field hospitals. The cost per test is forecasted at only $20 for each disposable hand-sized cartridge.

GeneCapture’s future products will screen a human/animal sample for up to 200 pathogens in less than an hour.  Their CAPTURE PLATFORM™ (Confirming Active Pathogens Through Unamplified RNA Expression) requires neither enzymes nor refrigeration and will have an expected shelf life of over a year. The product is envisioned for point of care applications including remote rural health and military operations. 

The initial molecular binding concept was conceived at The University of Alabama in Huntsville (UAH) and licensed to GeneCapture, which is an associate company at the HudsonAlpha Institute for Biotechnology - one of the world’s leading genomics centers. The company has since filed an additional 11 patents, built prototypes, and performed successful pre-clinical validation tests. In addition to the commercial applications, the company has been awarded multiple Department of Defense contracts to mature the technology for potential far-forward military operational use.

The closed cartridge accepts a direct sample (urine, blood, swab) and then concentrates and exposes the pathogen’s RNA fragments to the custom DNA probes on an array. Once the RNA is captured, the specific probes activate an optical sensor. The pattern across the array identifies the pathogen. Limits of detection have been validated and are currently clinically relevant for most bacterial infections, and are being optimized for viral infections.

Louise O’Keefe, PhD, Director of the Faculty and Staff Clinic at UAH, and an advisor to GeneCapture says, “Our industry needs a breakthrough in turnaround time for diagnostic results.  GeneCapture’s approach could transform that challenge we deal with every day.”

The GeneCapture team has briefed the Food and Drug Administration (FDA) on its approach and has begun the process to prepare for the clinical testing required for FDA clearance. 

The company is in discussions with industry leaders for various applications in health care infection detection. 

 

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Photo caption: GeneCapture’s disposable cartridge integrates sample prep and pathogen identification in its rapid, portable ‘sample-in answer-out’ pathogen identification platform.

About GeneCapture: GeneCapture is developing products for commercial and government applications for point of care diagnostics. The company’s patented CAPTURE PLATFORM™ performs direct RNA hybridization to rapidly identify infectious disease organisms from urine, saliva and blood. The ability to detect up to 200 pathogens from a single run at an expected price of $20 sets the CAPTURE PLATFORM™ apart. With the addition of antimicrobial susceptibility testing to their offerings, GeneCapture is in a position to bring the capabilities of a microbiology lab to point of care applications and to underserved locations in the U.S. and around the world. 

About HudsonAlpha: HudsonAlpha Institute for Biotechnology is a nonprofit institute dedicated to developing and applying scientific advances to health, agriculture, learning, and commercialization. Opened in 2008, HudsonAlpha’s vision is to leverage the synergy between discovery, education, medicine, and economic development in genomic sciences to improve the human condition around the globe. The HudsonAlpha biotechnology campus consists of 152 acres nestled within Cummings Research Park, the nation’s second largest research park. The state-of-the-art facilities co-locate nonprofit scientific researchers with entrepreneurs and educators. HudsonAlpha has become a national and international leader in genetics and genomics research and biotech education and fosters more than 40 diverse biotech companies on campus. To learn more about HudsonAlpha, visit hudsonalpha.org.

About UAH: Launched from America’s quest to conquer space, The University of Alabama in Huntsville is one of America’s premier doctoral-granting, research-intensive universities. Located in the second largest research park in the United States, UAH has robust capabilities in astrophysics, cybersecurity, data analytics, logistics and supply chain management, optical systems and engineering, reliability and failure analysis, rotorcraft and unmanned systems, severe weather, space propulsion, and more. UAH prepares students for demanding positions in engineering, the sciences, business, nursing, education, the arts, humanities, and social sciences.