Lucigen has raised nearly $2 million from angel investors to help fund tests needed to win regulatory approval for its rapid molecular diagnostic technology that will initially target Ebola and Clostridium difficile, or C. diff.
Middleton, WI-based Lucigen, founded in 1998 as a supplier of life sciences research products, got into diagnostics several years ago when it began developing a nucleic-acid based test that it says can identify pathogens within 30 minutes using a blood sample and a battery-powered instrument the size of a laptop. The idea is to offer a simple test that can be performed by healthcare workers in the doctor’s office or out in the field. This would be an improvement over the typical scenario that requires shipping samples to a far-away lab for testing by highly trained technicians—a process that typically doesn’t return results for a couple of days.
Lucigen leaders envision the test being used to sniff out a multitude of conditions, from common infections like the flu or strep, to more serious diseases. It’s going after C. diff and Ebola first.
Investors have pumped more than $4.6 million into the company since 2004, SEC documents show. The new money, combined with revenue flowing from Lucigen’s research products business, is expected to cover the costs of the studies needed to win approval of the diagnostic for limited use, namely in testing for Ebola and C. diff, CEO Ralph Kauten says. “We’re just arranging all the resources we’re going to need to hit those milestones,” he says.
Lucigen plans to launch a clinical trial this year using the platform to test around 1,000 patient samples for C. diff, a bacterial infection that can cause diarrhea and life-threatening inflammation of the colon. Executives hope to begin selling the test for that use in 2016, after securing U.S. Food & Drug Administration clearance to market the medical device, Kauten (pictured above) says.
C. diff was Lucigen’s initial target, but last year it began simultaneously rushing to validate its technology in testing for Ebola, after the company was contacted by the Centers for Disease Control and Prevention amidst a surging outbreak of the disease in West Africa. The diagnostic has been used on a small scale at the CDC’s Atlanta headquarters and in Africa.
Now, it’s undergoing further vetting. That includes making sure the technology works under different circumstances and in different environments, as well as ensuring it returns accurate results without interference from compounds in the body, Kauten says.
The company is seeking emergency use authorization from the FDA to market the on-the-spot pathogen test specifically for Ebola detection. Kauten expects that approval to come by the middle of this year.
“There’s a number of steps we need to go through to validate the tests,” Kauten says. “We’re working through those steps.”