NEW YORK (GenomeWeb) – Following the planned launch of a series of liquid biopsy cancer tests over the next six months, Transgenomic is aiming to broadly license the multiplexed PCR-based technology that powers the products to instrument and reagent firms, according to President and CEO Paul Kinnon.
Once it has done so, Kinnon told GenomeWeb this week, the firm plans to decide whether there are any applications or specific disease areas in which it wants to maintain exclusivity with the technology.
Those are choices for the future, he added. Right now, "it's about broad adoption rapidly."
Called ICE COLD PCR — short for improved and complete enrichment co-amplification at lower denaturation temperature PCR — the technology was originally developed at the Dana-Farber Cancer Institute and takes advantage of the fact that mutant DNA strands denature at lower temperatures in a PCR reaction than normal DNA strands, enabling selective amplification of the mutant DNA with minimal amplification of normal DNA.
It was later enhanced through the use of locked nucleic acids and a reference strand that binds PCR amplicons to form duplexes that are preferentially denatured and amplified at a certain temperature. According to the company, the technology offers up to a 500-fold increase in sensitivity over other methods, down to .01 percent frequency from as little as 4 to 5 ml of plasma.
Transgenomic exclusively licensed ICE COLD PCR from Dana-Farber in 2009, and last year expanded its license to include multiplexed versions of the technology.
With those rights in hand, Transgenomic set out to optimize and commercialize the technology, beginning with research-use-only mutation enrichment kits that were launched earlier this week. According to the company, the kits are customizable and the initial menu includes 17 clinically relevant, actionable mutations that are associated with important cancers.
"We spent 18 months [working on the technology], focusing it on the mutations of interest in specific cancers and refining so it works on Sanger [sequencing], next-generation sequencing, and digital PCR platforms," Kinnon noted.
With the RUO kits now available, the company is setting its sights on launching before the end of the year six new lab-developed tests based on multiplex ICE COLD PCR that can identify genetic mutations and alterations, either alone or in combination, associated with melanoma, non-small cell lung cancer, and colorectal cancer.
The company did not disclose specific details about the tests, but Kinnon said that they will include the mutations covered by the firm's RUO panels. He added that they will be sold for diagnostic use through the company's CLIA-certified laboratory, and can be used with standard tissue or liquid biopsy samples.
Though liquid biopsy cancer tests represent a relatively new field, enthusiasm around them is growing. As a result, Kinnon does not anticipate difficulty finding a market for the new multiplex ICE COLD PCR tests or catching the attention of life science companies that could license it.
"Most oncologists, most scientists, [and] the CEOs of most large healthcare companies know the benefits of liquid biopsy," among which are relatively low costs compared with obtaining tissue biopsies, he said "The value proposition is there. … The market is going to liquid biopsies."
Kinnon added that while cancer represents a key near-term opportunity for ICE COLD PCR in the liquid biopsy space, he expects the technology to have applications in all areas where genetic mutation analysis is used diagnostically.