Durham's Qualyst Launches New Test for Avoiding Liver Toxicity

By Allan Maurer, NC Biotech Writer

Durham-based Qualyst Transporter Systems (QTS) has launched a new test that can steer drug developers away from compounds that could cause liver damage.

The company’s latest lab assay is a novel way to test compounds for their potential to cause the serious liver problem called cholestiatic drug induced liver injury (DILI).

Some compounds cause DILI by disrupting the liver’s ability to control bile acids, resulting in toxic concentrations. The in vitro QTS C-DILI assay uses human liver cells in the lab. The test performs better than current tests performed in live animals such as rats, because the animals’ livers have a different mix of bile acids.

Christopher Black, Ph.D., CEO of QTS -- QTS photos

“We have shown excellent clinical predictions with the assay in over 50 clinically described compounds; we truly have something that is next-generation”, said Christopher Black, Ph.D., CEO of QTS.

Black joined venture-backed QTS, previously named Qualyst Inc., when it relaunched under its new name and with new investors in 2012. Originally founded in 2002, Qualyst licensed its technology from Kim Brouwer’s lab at the University of North Carolina at Chapel Hill. “The original strategy of licensing the technology to other companies did not work out for a variety of reasons,” Black said in an interview with the North Carolina Biotechnology Center.

Qualyst received a $13,000 loan from the Biotech Center in 2003, and the following year gave UNC a Collaborative Funding Grant of $57,000 to help develop the original technology. The Center also provided Qualyst with a $133,750 Small Business Research Loan in 2006.

“In 2012 new investors came in and I was brought in to see if we couldn’t find a better way to commercialize the company,” Black said. The company has not disclosed its backers or the amount invested.

Turning that technology into products and services has “been going very well since,” Black said. The 17-employee company has grown more than 100 percent since 2012 and “quickly reached profitability,” he added.

Graham Dyck, QTS director of commercial strategy and marketing

“We are a company that provides products and services for in vitro liver modeling to investigate drug, herb, cosmetic and food interactions,” explains Graham Dyck, QTS director of commercial strategy and marketing. “We collaborate with a broad range of pharmaceutical and biotech companies to help them understand the impacts of their products on the liver. In addition to pharma, we work with industries in the cosmetic space and those with nutritional and dietary supplement products.”

What is unique in the QTS products, Dyck said, is that “Our in vitro liver models evaluate the uptake and efflux (outflow) functions, which makes them more lifelike. We have demonstrated we are superior in predicting how the liver will clear a compound compared to traditional models.”

“We are certainly leaders in the industry, Black said. “We’re the liver experts.”

QTS sells several liver assay kits and services generally customized for a client.

The company declined to name clients, citing confidentiality agreements.