GREENSBORO – Who’d have thought a horseshoe crab could make the difference between life and death?

As it turns out, the blue blood from these crabs contains limulus amebocyte lysate (LAL), a liquid extract of blood cells that can provide one of the most accurate ways of rapidly identifying bloodborne infections. The work of Greensboro-based Kepley Biosystems to grow horseshoe crabs and use their LAL for diagnostic purposes has gotten the attention of the National Science Foundation.

The NSF has awarded a $1 million Small Business Innovation Research Phase II grant to support Kepley’s development of its bloodstream infection detection technology. The LAL extracted from horseshoe crabs rapidly reacts to pathogens at parts-per-trillion levels, or about the same sensitivity as adding a single drop of water to 20 Olympic-size pools, the company said.

The fast detection of bloodborne infections before sepsis – the body’s life-threatening overreaction to infection – sets in is crucially important. The risk of death from this condition increases by 8% every hour a patient goes without appropriate treatment. So, diagnosis within one to three hours using a small sample of LAL that can tell the difference between pathogen types could make a big difference in healthcare, according to Kepley.

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The research picture

Other lengthier testing methods also can contribute to antibiotic resistance as doctors try a variety of drugs before settling on an accurate diagnosis.

Sepsis currently is the leading cause of hospital mortality, accounting for close to 49 million deaths globally each year. It also ranks as the most expensive healthcare challenge, according to Kepley, costing $62 billion annually in the U.S. alone.

“If we can impact the entire continuum of care – from admissions through patient care and discharge – by identifying infections early and optimizing treatments, this work could save lives,” said Rachel Tinker-Kulberg, Ph.D., Kepley’s director of research and development.

The recent NSF grant isn’t the first Kepley has received from the agency. NSF provided $225,000 in Phase I feasibility funding in 2018 that demonstrated the potential for a more-affordable screening assay that could provide same-day treatment guidance. The company also has been a finalist in the North Carolina Biotechnology Center’s venture challenge program.

“It’s rewarding to see additional investment in Kepley BioSystems to help advance the commercialization of its important research,” said Nancy Johnston, executive director of NCBiotech’s Piedmont Triad office.

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A horseshoe ranch to corral LAL

Over the past several years, as part of their research, Kepley scientists have gained significant experience in horseshoe crab husbandry.

In 2018, the company announced plans to develop its Horseshoe Crab Ranch and Blood Institute. The idea was to create an environment where the crabs could be fed, monitored and carefully bled for LAL, to minimize the impact on their well-being and to improve survival rates. The end game was to establish an ecosystem that can preserve their health, while eliminating the need to capture them in the wild.

Close to 600,000 horseshoe crabs are caught from the Atlantic seaboard each year so their blood can be harvested for LAL that is used primarily to test the sterility of drugs and medical devices. While most crabs are returned to their natural habitat, an estimated 30% don’t survive the experience.

Add that to a similar number captured and used for fishing bait, and you begin to threaten the viability of an ancient species that has been around for more than 450 million years. So there are environmental benefits as well.

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About Kepley BioSystems

Ph.D. scientist Christopher Kepley and corporate advisor Terry Brady founded Kepley BioSystems in 2013. Anthony Dellinger, a Ph.D. neuroscientist, is the company’s president.

The business operates out of Gateway University Research Park in Greensboro in collaboration with the Joint School of Nanoscience and Nanoengineering, a partnership between the North Carolina Agriculture and Technical State University and the University of North Carolina Greensboro.

Dellinger said Kepley is seeking a partnership with a global industry leader to bring its technology to hospitals that urgently need new sepsis management tools, while also reducing the threat of antimicrobial resistance.