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PCR Probe Licensing Pact with Focus Diagnostics Portends 'Busy Year' for Evogen

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Evogen, a Lenexa, Kansas-based developer of molecular detection and diagnostic technologies, said this week that it has non-exclusively licensed its PCR probe technology to Focus Diagnostics, a Quest Diagnostics subsidiary.

Under the agreement, Focus has been granted the right to incorporate Evogen's HyBeacons PCR probe technology into molecular diagnostic products and services.

Focus will incorporate the HyBeacons technology – which enables same-time melt curve analysis and simplifies multiplexing design – into multiplexed molecular assays under Focus' Simplexa brand for use on the 3M Integrated Cycler, according to the company.

For Evogen, the agreement, along with several recent changes to the company's executive management team, portends "a busy year" for the company in terms of licensing HyBeacons to partners and developing its own molecular diagnostics for infectious disease and, potentially, cancer biomarkers, a company executive said this week.

Evogen was founded in 2002 as a spinout from the Midwest Research Institute following the US anthrax attacks to commercialize its SpinCon air sampling technology.

In 2008, Evogen acquired the worldwide exclusive rights to the HyBeacons PCR probe technology from LGC, along with sublicensing rights for specific market areas.

HyBeacons are sequence-specific hybridization probes containing two fluorophores per probe to create a robust fluorescent signal, according to the company.

Since HyBeacons are not hydrolyzed during PCR amplification, positive confirmation of the amplicon is available by way of high-definition melt curve analysis. The company said that HyBeacons are easy to design, which offers the ability to multiplex different color probes to identify multiple targets in a single reaction; and provide clear quantitative data during amplification and have proven capabilities with DNA and RNA targets.

"HyBeacons allow the type of amplification that you get with all other PCR probes, but also has same-time melt curve analysis," Rich St. Clair, vice president of commercialization at Evogen, told PCR Insider this week.

In general, he noted that HyBeacons' ease of design, structure, and multiplexing capabilities "allows us to really simplify the detection and diagnostics into a single assay for multiple targets."

"For something like Clostridium difficile, knowing that the different toxin [genes] melt at a different temperature, we can … design an assay that could detect toxin A, toxin B, and toxin C with an internal control," he added. St. Clair also provided the example of Dengue fever, which is caused by one of four related viruses. "We can multiplex all four serotypes in a single test," he said.

St. Clair said that the assays incorporating the probes can be optimized for use on any real-time PCR platform – preferably but not necessarily one capable of performing high-resolution melt analysis.

Focus signed an exclusive distribution agreement with 3M in early 2009 to marry Simplexa molecular diagnostic kits developed by Focus with 3M's Integrated Cycler platform, targeting customers at hospital laboratories.

Since then, Focus has commercialized a few Simplexa assays for the Integrated Cycler, including the Simplexa Flu A/B and RSV direct test, which in October received 510(k) clearance from the US Food and Drug Administration with a moderate-complexity CLIA categorization (PCR Insider, 10/11/2012).

The companies have also marketed the Simplexa C. difficile universal direct test; as well as the first FDA-cleared molecular test for influenza A H1N1. Also, in 2011 Focus said it was collaborating with Scripps Translational Science Institute and Scripps Health to develop a CYP2C19 genotyping test to aid physicians in predicting a patient's response to clopidogrel, sold by Bristol-Myers Squibb under the brand name Plavix (PCR Insider, 3/17/2011).

St. Clair said this week that Focus is specifically looking to use the HyBeacons technology for multiplexing, but declined to provide additional details on the targets, citing a confidentiality agreement.

In an email to PCR Insider, Michelle Tabb, vice president of research and development for Focus, said that the company "plans to use HyBeacon technology to facilitate a higher degree of multiplexing for our Simplexa molecular tests on the 3M Integrated Cycler platform. We are interested in pursuing applications in both infectious disease and human molecular genetic targets."

The agreement with Focus is the first HyBeacons licensing technology for Evogen, which has "a very competitive royalty structure" for the technology that it is able to "pass on to customers," St. Clair said. He added that the company is currently in discussions with other potential partners, and that it is looking to disseminate the technology in a wide variety of biomedical testing markets, as well as applied markets such as biodefense and food safety.

Evogen is also developing its own assays using HyBeacons.

"We've done studies on C. diff as well as other infectious disease … and cancer biomarkers," St. Clair said. "We're heading down the path of 510(k) [to commercialize] these."

To support these efforts, St. Clair was recently promoted by the company to his current position from director of marketing and business development. In addition, the company recently appointed a new CEO, Hans Kastensmith; and COO, Robert Dondes.

"One of the reasons [Kastensmith and Dondes] were brought in, and I was promoted, is to look at what we can and should commercialize," St. Clair said. "We're expecting a very busy year."

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