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Fluoresentric Sets Sights on Point-of-Care Dx With New Instrument Subsidiary


NEW YORK (GenomeWeb) – It's been a long and winding road for Fluoresentric's proprietary DNA amplification technology, but the firm is hoping that road will lead to the potentially lucrative point-of-care diagnostics market.

The Park City, Utah-based firm said this week that it is launching a new subsidiary to make portable hand-held instruments to run infectious disease assays based on its proprietary chemistry in pharmacies, retail clinics, warehouses, and anyplace where molecular diagnostics has yet to find widespread use.

Fluoresentric has for several years been developing its proprietary nucleic acid amplification chemistry now known as XCR, for Xtreme chain reaction, formerly known as dynamic flux amplification. The assays can run on PCR machines, but are faster and easier to work with than PCR, CEO Bill Olson told GenomeWeb.

"We can run our cycles much faster [than PCR] and operate in temperature ranges PCR doesn't," he said, adding that XCR chemistry can hit its limit of detection with up to 125 nL of whole blood remaining in the sample, making for easier sample preparation. "All of this allows for much simpler instrumentation and speed," he said. An XCR assay can run in under 10 minutes, he said.

Olson thinks that the chemistry could flourish if set free from existing expensive PCR instrumentation, which can cost tens of thousands of dollars per instrument. With a smaller footprint — and price tag — Olson thinks that XCR could bring molecular diagnostics to a point-of-care setting in places like retail clinics and pharmacies in the US and around the world.

There are thousands of pharmacies, retail clinics, physicians' office labs, and hospital emergency rooms in the US offering more than 100 CLIA-waived diagnostic tests, Olson said, but almost none of them are molecular diagnostics. "If we penetrate 15 percent of that market in four years, we'll have $500 million in sales in just those markets alone," he said.

To address those markets, FIuoresentric's new subsidiary, XCR Diagnostics (XCR Dx), will make a CLIA-waived point-of-care handheld instrument with an exclusive license for such technology from Fluoresentric. It will fit in the palm of a hand, Olson said, and can use the optics of a cell phone. The subsidiary will also have a license to use the XCR chemistry, though it won't be exclusive. The chemistry remains the key play for Fluoresentric and XCR Dx is just a part of Olson's master plan for the company.

Five years ago, dynamic flux amplification was in the hands of Fluoresentric subsidiary Signal Diagnostics, and licensed to the parent company to create assays to run on PCR machines.

Fluoresentric has since dismantled Signal Dx, regained the IP rights to the amplification tech, renamed it XCR, andbegun developing assays with it. On its website, the firm lists more than two dozen research-use-only assays for infectious disease testing in clinical settings and applied markets like animal science and food safety. Olson said Fluoresentric has also considered making assays for biodefense and oncology.

For now XCR Dx is a wholly owned subsidiary of Fluoresentric, but Olson said he plans to court investors while holding on to a significant stake in XCR Dx. The new subsidiary already has a Chief Operating Officer, Mark Powelson.  

The plan for XCR Dx is to first get a test approved by the US Food and Drug Administration, and then seek CLIA waiver for the test on its point-of-care instrument, Olson said. The company has yet to disclose what that first test will be, but Olson said Fluoresentric has considered both an influenza test and a sore throat assay that would test for Groups A, B, and G Streptococcus and Fusobacterium necrophorum. He mentioned that the firm felt it had a successful outing at last month's Clinical Virology Symposium and is finalizing paperwork to establish several experts as key opinion leaders to help guide the final decision of which assay to pursue first.

Olson conceded that XCR Dx's point-of-care molecular diagnostics play could be "a lot to swallow" for the US Food and Drug Administration, which issues CLIA waivers, but said he was optimistic. He pointed to the recent CLIA waiver granted to the Alere i Influenza A&B test as a sign of a softening regulatory environment.

"We were pretty encouraged, given the amount of required hands-on time, that [the Alere flu test] actually received a CLIA waiver," Olson said. "Perhaps we're in a regulatory environment that's starting to loosen up a little bit in addressing real solutions to cost of healthcare, and that is a continuing dependency on new instruments to deliver lower cost healthcare. That's what we bring to the table."