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Life Tech Adds to Clinical NGS Partnerships With University of Buffalo, Empire Genomics Deal

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The University of Buffalo and its spin-off molecular diagnostics company, Empire Genomics, have announced a partnership with Life Technologies to develop and commercialize sequencing-based tests using the Ion Torrent Proton and PGM.

Through two sequencing facilities — one at the university’s Center of Excellence in Bioinformatics and Life Sciences and one at the company's Buffalo headquarters — the partners plan to develop sequencing-based assays, potentially for a number of different disease areas, and to seek NY state and CLIA approval to offer them clinically.

Norma Nowak, director of science and technology at the UB Center of Excellence and the founder of Empire Genomics, told Clinical Sequencing News this week that the company is hoping its expertise in clinical diagnostics development will help it gain CLIA and NY state approval for the NGS platforms for both the company and university, while the university's next-gen sequencing experience will support the partnership's research and development efforts.

"The idea is that it is a symbiotic relationship," she said. "We are planning on leveraging the company's experience going down the [clinical approval] path to do it for the university… and the sequencing core at the university has almost seven years experience with next-generation sequencing, so the company can then leverage that experience."

While Nowak could not share financial details of the new partnership, she said that Life Tech has been "very supportive" from both a technology side, in providing sequencing instruments, and also "helping get the instruments up and running and getting started developing assays."

She said that the University facility has been provided two instruments — both the PGM and the Proton — and that Empire will be working only with the PGM.

While the partners do not yet have concrete plans in terms of what assays they aim to develop, Nowak said the university has expertise in neurodegenerative disorders and is also "looking into coagulation disorders."

According to Nowak, the Buffalo group is also looking at potentially developing content around adverse drug reaction testing and other areas of personalized medicine.

Additionally, she said, the University is in the process of building a new children's hospital, which could also benefit from the partners developing sequencing-based tests.

"As the hospital moves forward, it will become more clear [what assays will be developed]," said Nowak. "We look to things like the Boston Children's Hospital's partnership with Life Tech as a similar model," she said.

In January, Boston Children's and Life Tech announced the creation of a new company, Claritas Genomics, to develop diagnostics on the Ion Torrent platforms for inherited pediatric diseases (CSN 1/9/2013).

At the time, Life Tech CEO Greg Lucier said that the firm was interested in developing similar partnerships with other universities as it moves toward establishing the Ion Torrent technology in the molecular diagnostics field.

Life Tech has also said previously that it plans this year to submit the Ion Torrent PGM to the US Food and Drug Administration for 510(k) clearance.

According to Nowak, the University of Buffalo's sequencing core also works with Illumina technology. But in developing this partnership with Empire, the two decided to go with Ion Torrent because they anticipated that its acceptance among the molecular diagnostics and pathology community may be more robust than other platforms as array-based tests start to transition to next-gen sequencing.

"It really came down to looking at where pathology labs are going to go and where molecular diagnostics labs are going to go," she said. "We thought that the PGM is going to gain a lot of acceptance.

"Also, we are generating really good data from our PGM, so we have been very pleased with that," she said.

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