Ebola Outbreak a Proving Ground for Lucigen’s Rapid Diagnostic

Xconomy Wisconsin — 

Two years ago, no one could’ve predicted the worst Ebola outbreak in history would hit West Africa this year. And Lucigen—a small Wisconsin life sciences company with a federal grant to develop a simpler, faster test for diagnosing serious pathogens—certainly didn’t expect to play a part in the effort to assess and contain the deadly disease.

But a couple of months ago, the Centers for Disease Control and Prevention contacted Lucigen about the rapid, on-the-spot pathogen detection technology that the 52-person company has been developing in Middleton, WI. Lucigen, founded in 1998 as a supplier of life sciences research products, had in 2012 won a three-year, $1.7 million grant from the National Institute of Allergy and Infectious Diseases to help further development of the diagnostic technology.

The idea is a nucleic-acid-based test for quickly spotting infections in patients’ samples right at the point of care in, say, a hospital or doctor’s office. The technology has a multitude of applications, Lucigen says, from sniffing out common infections like flu and strep to diagnosing more serious diseases—including Ebola.

Lucigen’s technology drew the CDC’s attention because the diagnostic test can be performed by healthcare workers in the field, and it returns results within 30 minutes or so. That would be a huge improvement over the current practice of 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 intended for its diagnostic platform’s first commercial use to be in detecting Clostridium difficile, or C. diff, a bacterial infection that can cause diarrhea and life-threatening inflammation of the colon. The company is still planning to start a clinical trial testing for C. diff early next year, and if it receives U.S. Food & Drug Administration approval, Lucigen could begin selling the product in 2016, business development director Hemanth Shenoi said.

But the Ebola outbreak has spurred more urgent demand for Lucigen’s new—and still largely unproven—technology.

“Our goal is have a rapid point-of-care Ebola diagnostic test available in months, not years,” Shenoi said in an e-mail message. “The global crisis is too great, and one of the major unmet needs is for rapid point-of-care diagnostics that can aid with triage decisions—quarantining those who are truly infected with Ebola.”

Lucigen isn’t the only company rushing to push more advanced Ebola testing methods into the market.

Colorado-based Corgenix Medical (OTC: CONX) got a three-year, $2.9 million federal grant in June to continue developing a faster Ebola test that could be used at clinics and in field labs near outbreaks. But Corgenix stressed in August that the test is nowhere near ready for use, and the company is aiming to have it ready for the next Ebola outbreak.

Meanwhile, Roche indicated in October that it’s considering applying for an emergency, fast-tracked FDA approval to use its rapid diagnostic technology for Ebola testing. But Roche’s test is only for use in labs that meet certain safety requirements, according to a Reuters article, so it might not be used as widely as Lucigen intends with its test.

Ralph Kauten“We have a very simple test that anybody with a little training could execute,” newly appointed Lucigen CEO Ralph Kauten (pictured left) said.

Basically, the test involves heating up a test tube that holds a small blood sample, perhaps using a battery-powered heat pad. Then, the sample is transferred to a reaction tube that gets inserted into a laptop-sized, battery-powered instrument manufactured by Lucigen partner Douglas Scientific, which performs the chemical reaction developed by Lucigen that determines if the Ebola virus is present. (For a more detailed description of how the technology works, see Xconomy’s profile of Lucigen from January.)

At the CDC’s Atlanta headquarters, the agency initially vetted Lucigen’s diagnostic platform by testing blood samples taken from Ebola patients, Shenoi said. That gave the CDC enough early evidence that the technology works, and the agency requested 30 test kits from Lucigen that have been sent to Africa, he said.

Lucigen isn’t being paid by the CDC, although that could happen if the technology can be proven to consistently work, Kauten said. “I think they’re still getting a comfort level with its performance.” The partnership is an opportunity for Lucigen to learn more and improve the technology, he added.

Now, Lucigen is seeking emergency use authorization from the FDA that would allow it to market the on-the-spot pathogen test specifically for Ebola detection. “We’ve got people contacting us already to try to help us establish a distribution system in Africa,” Kauten said. “There may be some interest in the U.S. That’s yet to be determined.”

The idea would be to deploy the test in “low-resource clinical labs” in Africa and potentially in U.S. emergency rooms, for use by nurses and other medical personnel, Shenoi said.