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Transgenomic Suspends CLIA Lab Operations, Reviews Strategic Alternatives

NEW YORK (GenomeWeb) – Transgenomic has suspended operations at its patient testing laboratory while it considers strategic alternatives for the facility as part of the firm's ongoing efforts to sharpen its focus on its ICE-COLD PCR molecular diagnostics technology, according to a filing with the US Securities and Exchange Commission.

In the filing, Transgenomic said that it has not set a timetable for the strategic review and evaluation process, although CEO Paul Kinnon told GenomeWeb that additional details about the New Haven, Connecticut-based lab will be provided during the company's upcoming Q4/FY2015 earnings call.

He added that Transgenomic has not publicly disclosed information about any layoffs associated with the halted operations.

ICE-COLD PCR — short for improved and complete enrichment co-amplification at lower denaturation temperature PCR — involves the selective amplification of mutant DNA, which can be achieved because mutant DNA strands denature at lower temperatures than normal DNA in a PCR reaction. The technology also incorporates locked nucleic acids and a reference strand that binds PCR amplicons to form duplexes that are preferentially denatured and amplified at a certain temperature.

Transgenomic first acquired the rights to ICE-COLD PCR from the Dana-Farber Cancer Institute in 2009, and expanded the arrangement to include multiplexed versions of the technology in 2014. 

Transgenomic has become increasingly committed to the technology, primarily in cancer and personalized medicine, and has been divesting other assets including its Surveyor Nuclease technology in 2014, its ion chromatography business in September, and its Genetic Assays and Platforms unit in December.

According to Kinnon, the decision to halt operations at the New Haven CLIA lab, which performed cardiology and neurology genetic testing, represents another step toward "trying to draw all the resources of the company around" ICE-COLD PCR, while also generating non-dilutive funding.

"Raising capital can be brutal at the moment, so the focus has to be on non-dilutive funding and making the ICE-COLD business profitable," Kinnon said. 

Indeed, recent conditions on Wall Street have been less than favorable for Transgenomic, which ended the third quarter of 2015 with $2.8 million in cash and cash equivalents, and in January raised $2.2 million in a private placement of preferred stock and warrants.

In late February, though, the company disclosed that it had been notified that its shares faced delisting from the Nasdaq for failure to maintain the $1.00 minimum bid price. The company has until Aug. 22 to regain compliance with this rule. 

During mid-day trading on Monday, shares of the firm were unchanged at $.62 apiece.