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

Xconomy Wisconsin — 

[Corrected 1/30/14, 8:58 am. See below.] Lucigen’s ambitious plan to challenge big diagnostic firms with its own rapid tests for infections like flu and strep traces its origins to a Yellowstone National Park hot spring dubbed “Octopus Spring.”

That’s where molecular biologists David Mead and colleague Tom Schoenfeld in the early 2000s discovered an enzyme that will now form the key ingredient in their Middleton, WI, company’s planned test for quickly identifying pathogens.

Mead founded Lucigen, a small life sciences supplier, in 1998 because he thought it would be fun to try running a company and get off the bench as a research scientist at Wisconsin companies like Promega and Molecular Biology Resources. He hoped to strike another success like he had as a University of Wisconsin-Madison researcher, where a decade earlier he invented TA cloning, a genetic cloning technique he licensed to Invitrogen, now part of Life Technologies (NASDAQ: LIFE).

Mead and Schoenfeld, a fellow research scientist and Lucigen’s first hire, set out to Yellowstone to find unusual viruses from which they could isolate enzymes that would be superior to the ones that researchers were using at the time for processes like genetic sequencing, Mead said. They found a promising one, a so-called polymerase, but it took several years to figure out their enzyme’s true potential, he said.

Lucigen has since sold the enzyme, which it markets as OmniAmp, to life sciences researchers for use in experiments that require making lots of copies of specific genetic sequences. But Lucigen staff recognized a few years ago that the enzyme wasn’t ideal for research use, since it didn’t allow researchers to copy long enough sequences for many of their studies. They eventually realized, however, that if they used the enzyme in a process called Loop-mediated Isothermal Amplification (LAMP), it could easily handle short sequences that are unique signatures for various viruses and bacteria—and that that would allow for quick detection of a host of pathogens.

“It took us a long time to figure it out. We just kept throwing [ideas] against the wall, and it would fall,” Mead said.

Diagnostics is a new direction for the 16-year-old company and its 55 employees, who primarily supply life sciences researchers with a suite of products that enable genetic cloning and sequencing. It’s also an ambitious one that will pit Lucigen against big diagnostics firms in the race to develop an FDA-approved nucleic acid-based test for quickly detecting infections in patients’ samples right at the point of care in, say, a hospital or doctor’s office.

Why the pivot? Mainly to enter a much larger and faster-growing market. Over the next five years the life sciences research market is projected to at best grow in the low single digits, mainly due to shrinking availability of federal research grants, said Lucigen President Jeff Williams. [An earlier version of this paragraph gave an incorrect estimate of the size of the life sciences research market. We regret the error.]

Meanwhile, getting into point-of-care testing opens up a global market of hundreds of thousands of doctor’s offices, clinics, and eventually pharmacies, Mead said. Global research and consulting firm Frost & Sullivan valued the point-of-care test market at $5.7 billion in 2013, and expects it to exceed $9 billion in 2019. The top three players are Alere, Danaher (NYSE: DHR), and Roche, said Srinivas Sashidhar, Frost & Sullivan’s senior life sciences research analyst.

And Lucigen is also embarking on this effort with an eye toward getting acquired by a bigger player in the market, Mead said. Scooping up smaller companies with promising tests has been part of the strategy for companies like Alere, which this month announced the release of a product in Europe that rapidly tests for the flu (results in 15 minutes) using a process similar to what Lucigen will utilize in its competing product.

The problem such tests are trying to solve is … Next Page »

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