Fluoresentric to Launch XCR Dx Subsidiary

Company Finalizes New Instrument Business Unit Plan to Cut Medical Lab Costs, Speed Test Results

SALT LAKE CITY--(BUSINESS WIRE)--Fluoresentric, Inc. today announced investment plans to spin out XCR Dx, a new wholly owned subsidiary focused on developing XCR™ chemistry hardware platform opportunities. All company instrument development and manufacture will now flow through XCR Dx. XCR™ assay development, XCR™ strategic partner relationships, sales and other XCR™ chemistry activities remain inside Fluoresentric, Inc. The plan allows Fluoresentric and its investors to focus more fully on specific markets in need of XCR™ breakthrough molecular diagnostic testing chemistries.

“We are talking about moving clinically relevant molecular diagnostic results into the already established CLIA approved environment in retail health clinics, physician office labs, pharmacies and hospital emergency rooms, where today over 120 CLIA waived diagnostic tests are already being offered, none of which are molecular”

“XCR™ promises to become the new standard for molecular diagnostic testing for greater personalization of healthcare,” states William Olson, CEO for Fluoresentric, Inc. “Our first instrument prototype is smaller, faster and more cost-effective than any other PCR platform in the market and outperforms all known PCR instruments, whether laboratory-scale or portable.”

This is phase two in the company’s plan to first demonstrate the chemistry’s flexibility and speed, then couple it with inexpensive instrumentation as a “Portable Diagnostic System” (PDS) for deployment in near patient settings. The investment plan calls for initial funding of $3 - $5 million.

Mark Powelson will serve as XCR Dx’s Chief Operating Officer to oversee final manufacturing design and scalability of the PDS as a first priority to prepare for planned FDA clinical trials. Potential partners and sales channels are already in development stage with enthusiastic support for the resulting product.

“We are talking about moving clinically relevant molecular diagnostic results into the already established CLIA approved environment in retail health clinics, physician office labs, pharmacies and hospital emergency rooms, where today over 120 CLIA waived diagnostic tests are already being offered, none of which are molecular,” states Mark Powelson, COO for XCR Dx. “Now that is groundbreaking.”

About XCR™

Award-winning and patented XCR™ is positioned to greatly improve molecular diagnostics in the lab, as well as at point-of-care. Fluoresentric assays are available now and they work with ubiquitous polymerase chain reaction (PCR) hardware in use today, but will perform optimally on the PDS. XCR™ combines the best of PCR and isothermal methods with none of their limitations. It is as much as 10-fold faster than PCR with resistance to classic PCR inhibitors, allowing for simplified sample prep, using low cost reagents on low cost portable instrumentation with high multi-plex capability.

The current standard for nucleic acid amplification requires 40 to 60 minutes, an unacceptable time for several critical testing areas, particularly at the Point of Care, where testing must be completed in less than 20 minutes to get a clinically actionable result. As a new approach to nucleic acid amplification testing (NAAT), XCR™ amplification and detection occurs in ~5 minutes with both DNA and RNA target nucleic acids. It eliminates amplification artifacts (e.g. primer-dimer) while dramatically reducing turnaround time, delivering a clinical result without compromise.

About Fluoresentric, Inc.

Fluoresentric Inc. is a start-up chemistry company positioned to monetize its XCR™ technology portfolio globally. Initially started as a custom PCR assay Design Company recruited by Roche to support their LightCycler^® thermal cycler, the company has designed over 1,000 PCR assays. Fluoresentric scientists are internationally recognized experts in the field of Real Time Polymerase Chain Reaction (PCR). The company’s XCR™ technology is positioned to dramatically trim test times, reduce healthcare costs, with a vision to deliver hyper-accurate molecular diagnostics testing at Point of Care.

*LightCycler^® is a registered trademark of Roche