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Lucigen Takes On Diagnostic Giants With On-the-Spot Pathogen Tests

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that when a person arrives at a doctor’s office or hospital with an apparent infection, accurately determining its root cause typically requires the doctor to take a sample of blood, saliva, urine, or other biomaterial and ship it to a central lab to be analyzed, which can take days or weeks.

With a point-of-care test like the ones Lucigen is developing, patient samples are analyzed on site in a device roughly the size of a desktop printer and the test result is ready within an hour or so. That means healthcare providers don’t need to track down patients after an appointment, and treatment options can be discussed right away, resulting in faster and potentially less expensive care.

These types of devices are still relative rarities in clinical settings, but the market is heating up and spurring new innovations.

Most current point-of-care tests for viruses and bacteria are based on antibody technology, but Sashidhar of Frost & Sullivan said the next frontier within this fast-diagnosis market is a nucleic acid-based test like the one Lucigen is working on. The technique, which utilizes DNA or RNA amplification to detect pathogens, can more accurately pinpoint the source of an infection and ultimately lead to better treatment, he said.

“Although it’s [in the] early stages and products are just coming out now, this particular market is promising,” Sashidhar said.

LucigenLucigen is spending some millions of dollars to develop its first of these molecular diagnostics, which will test for Clostridium difficile, or C. diff, a bacterial infection that can cause diarrhea and life-threatening inflammation of the colon.

In December, Lucigen’s facility received a key certification that enables the company to develop and manufacture diagnostic products and medical devices—an important step toward submitting a diagnostic test to the FDA, Lucigen said.

Lucigen is partnering with two companies in California that will design and manufacture the machine that would process its tests and the plastic cartridges that would hold patients’ samples; it declined to name these partners.

Lucigen plans to start clinical trials of the C. diff test in late 2014 and hopes to begin marketing the test in 2015. Mead and Williams envision expanding Lucigen’s menu of tests to include influenza, streptococcal infections, and sexually transmitted diseases, among others.

Assuming Lucigen secures the necessary approvals from the FDA and international regulators, the more daunting challenge will be winning against much larger companies that are already established in the point-of-care testing market and have more resources and a global distribution network, Sashidhar said. Besides Alere, Cepheid (NASDAQ: CPHD) and Becton, Dickinson and Company (NYSE: BDX) are among the companies also developing point-of-care tests similar to Lucigen’s, he said.

Mead is fully aware of what his small company is up against, and that’s why selling Lucigen is the ideal end game, he said.

“If you want to be successful fast, you partner with somebody who’s got the right resources and channels and who needs the technology,” Mead said. Though Lucigen might be second to market in the U.S. behind Alere, he said “that’s OK because there’s lots of diagnostic companies who have nothing [in this particular space]. This will be a nice competitive alternative to take up and go to market with.”

Lucigen officials believe that their company’s small size can be an advantage in a still-developing market. It allows Lucigen to have a startup’s mentality of being nimble and innovative, they said—two characteristics that can sometimes get stifled in the bureaucracy of large corporations.

“As a small company, we’re just full of ideas and naïve enough to think we can do things that no one else has,” said Williams, a former vice president of Roche Diagnostics.

Point-of-care testing could eventually make up 90 percent of Lucigen’s revenue if the company gets it right, Mead said. But even if the project fails, it will not spell doom for the firm, which can fall back on its core research products business that is growing revenue at a 20 percent clip annually, Williams said.

“We’re a successful company; we will continue to be successful,” Williams said.

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