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GeneCapture Validates Lab-Free ‘sample to prescription’ Infectious Disease Protocol in 2 Hours Instead of 3 Days

HUNTSVILLE, Ala. — GeneCapture, Inc., is cutting the time to diagnose an infection from several days to a few hours.

This week, the HudsonAlpha Institute for Biotechnology associate company demonstrated its breakthrough diagnostic technology to local clinicians and physicians. Their portable, lab-free platform enables identification of the correct antibiotic treatment in near real-time. While traditional hospital diagnostics can often take two to four days to process raw samples, GeneCapture’s technology uses a combination of sequence-based probes, biochemical reactions and optical cytometry to move from patient sample to prescription in 2 hours.

Imagine your child is sick. The doctor thinks it’s a bacterial infection, but determining which germ is causing it, and which antibiotic will actually work, requires sending a sample to a laboratory and waiting two to four days for results. During the wait, your child stays sick, or the doctor might start an antibiotic that is a safe bet. However, it won’t be known if that bet will work for your child’s particular infection until they have been taking it for a few days. This dilemma is about to be resolved.

“We’ve just completed an important milestone – a diagnostic study to determine which drugs would best treat a specific infection,” said Paula Millirons, GeneCapture Chief Scientist. “We manually validated the process and the results show an impressive 98% match to the gold standard results a hospital would obtain; however, we did it in 2 hours instead of the typical 2 to 3 days.”

“The speed to treatment will improve health outcomes, especially as antimicrobial resistance is on the rise,” said Louise O’Keefe, PhD, CRNP, and Professor Emerita at UAH, upon reviewing the data with GeneCapture scientists.

GeneCapture CEO Peggy Sammon said the implications of the study are far-reaching. “Imagine getting the right drug, right away, without a laboratory. This will reduce costs, contagion, and sepsis,” Sammon said. “Our goal is to provide inexpensive portable equipment to clinics, schools, nursing homes, cruise ships, rural health centers, and any location without laboratory access. The era of waiting days for results will soon be over.”

Local microbiologist Rhett Woody, ASCP (right) observes the disposable cartridge design with GeneCapture scientists Zac McGee and Scotlynn Lyon. Woody predicts “this approach will revolutionize the industry.”

Recent testing confirmed the rapid workflow, which was designed by a team of microbiologists and biomedical engineers at GeneCapture’s lab at HudsonAlpha. The innovations will allow a small disposable cartridge and a compact instrument to read the results. The technology can detect multiple pathogens. This specific study focused on urinary tract infections, a commonly misdiagnosed condition that can rapidly escalate into serious complications if not treated promptly and correctly.

GeneCapture’s sample to prescription approach is defined by three core innovations: a rapid pathogen identification system that uses a molecular signature-matching algorithm; a miniaturized biochemical growth chamber for accelerated bacterial growth; and a proprietary method for sorting, distinguishing, and counting the bacteria before and after exposure to antibiotics. The platform will accept urine, swab, and blood.

“We have come to expect significant breakthroughs from our associate companies, and GeneCapture’s latest achievement is a true ‘leap ahead’ for diagnostic care,” said Neil Lamb, PhD, president of HudsonAlpha. “This demonstration proves that the future for rapid, accessible infectious disease management is being built right here in Huntsville. We congratulate the entire team on this milestone.”

GeneCapture has successfully completed the FDA pre-submission process and is now preparing the cartridge and instrument for clinical tests. In addition to its commercial progress, the company has secured multiple government contracts to develop rapid infection diagnostic techniques for battlefield use, including a current contract focused on identifying the source of emerging unknown biothreats.

The platform will enable the company’s Global Infection Grid™, which will be a network for predicting global infection pathways and identifying mutations. Think of it as a weather map for infections: showing where dangerous strains are appearing, which antibiotics are losing their effectiveness, and where the next outbreak might hit.

Results can be shown on a tablet or in the electronic records and eventually will support the intelligent Global Infection Grid™.

About GeneCapture, Inc.

GeneCapture is an associate company on the campus of HudsonAlpha Institute for Biotechnology in Huntsville, Alabama. The company develops rapid, lab-free diagnostic platforms for infectious disease tracking, management and prediction.  Their library includes pathogens for human, animal, environmental, and biothreat applications. The data from tests all over the world will lead to its Global Infection Grid™ which will track and predict infectious outbreaks.   www.genecapture.com

About HudsonAlpha

HudsonAlpha Institute for Biotechnology is a nonprofit research institution using genomics to improve human health, secure the global food supply, and drive economic growth in the life sciences. With locations in Huntsville and Dothan, Alabama, HudsonAlpha accelerates the transition from lab discovery to real-world application by fostering a unique ecosystem of world-class researchers, educators, and more than 45 diverse biotech companies. From diagnosing rare diseases and developing more resilient global crops to training the next generation of STEM leaders, HudsonAlpha is improving lives today and building a more sustainable tomorrow.