When Dr. Krishna Chittur‘s young daughter was born premature, the doctor spotted some concerning cloudiness on a lung x-ray. The doctor suggested a dose of antibiotics for suspected pneumonia, followed by blood work to identify the infection. Chittur and his wife were concerned about what the antibiotics could do to their small newborn, plus dealing with an excruciating three-day waiting period for the results.
Infectious diseases kill over 17 million people a year, according to the World Health Organization, and Chittur wished there was a way to figure out what was causing the infection earlier, at what health specialists call ‘Day Zero’.
His colleagues and students at the University of Alabama in Huntsville, where the Ph.D. teaches chemical engineering, encouraged him to find someone that could turn his idea into a business. “This project not only had an interesting biological underpinning, but a high demand for undiagnosed illness. Having a way to do that faster and better is very compelling,” says the company’s now-CEO and co-founder Peggy Sammon, who has extensive experience leading startups.
Sammon attributes the close knit community of Huntsville, Alabama to her initial connection to Chittur. “Being part of the entrepreneurial community and Huntsville’s collaborative makes it easy for startups to connect with local scientists. Krishna was the designer behind the idea and once I read his patents, I was very impressed and I immediately thought this could make a successful business.”
Together they founded GeneCapture, a medical device startup based at genomic research institute HudsonAlpha Institute for Biotechnology in Huntsville. The concept is based on the original idea now-CTO Chittur had: Using genetics, they can rapidly identify an RNA signature of a germ-causing infection taken from a sample of blood or saliva.
With a patented disposable test cartridge the size of a smartphone, GeneCapture quickly identifies the piece of RNA, determining what specific bacteria, viruses, or fungi, is present in the sample, in less than an hour.
The plastic cartridge, inserted into a microwave-sized reader device, can also be updated within a few days with new pathogens or any mutated strains. The cartridge has a small micro array in it with probes that, each one designed to attract one specific RNA pathogen. The infection report can be sent wirelessly to a physician’s tablet and will display the negative and positive results for the requested pathogens.
In 2010, the startup won the $100,000 grand prize at Alabama’s Launchpad startup competition and a local angel investor matched the winnings, which helped them collect enough funds to start gathering data and validating their idea.
They spent the next few years automating the process and building the first versions of the device. In 2015, they brought on a chief scientist, Harvard biochemist Paula Koelle, to perfect the prototype. Koelle took the RNA identifying process from a few hours down to a standard 45 minutes. The next year, they once again took a $100,000 alumni grand prize at Alabama Launchpad, this time to expand their team with more lab employees.
“That’s our mission, to get infection detection out of the lab and into point-of-care facilities,” says Sammon. The cartridge’s affordability is a big priority for the GeneCapture team; it currently costs $20. It’s ideal for places where infections need to be quickly identified to prevent an outbreak, like nursing homes, small clinics, field hospitals, airports and cruise ships.
“The early adopters will be clinics, home health workers and nursing homes. Upon commercializing, we will start with pathogens that thrive in those three settings in the first phase,” says Sammon. For nursing homes, for example, popular issues are urinary tract or upper respiratory infections.
The medtech device has been further validated by the recent acquisition of a two-year, $1 million Small Business Technology Transfer Research contract from the U.S. Department of Defense’s Defense Threat Reduction Agency. Specific to the DoD contract, GeneCapture will develop a cartridge that identifies a set of pathogens that present potential biological threats to those serving at a war front. “The soldiers are far away from the hospital and they were looking for something that wasn’t in a lab,” says Sammon.
After several clinical validations, GeneCapture will soon enter the one-year process for Food and Drug Administration medical device clearance. Currently, they’re licensed to sell units for research-only applications, which can help them build an early revenue line. “We need to be careful, as we build an early revenue line, to prevent it from distracting us from our main goal and make sure it helps us. It’s one of those strategic issues that we’re working on right now,” says Sammon.
The GeneCapture team has been piloting the prototypes in local clinics to successful results. Next, they’ll be seeking out $6-8 million to start the commercialization of the product and finalize the FDA process toward the end of the year.