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VelaDx to Develop Oncology and Infectious Disease Tests on the Ion Torrent PGM

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Life Technologies said this week that it has signed a supply and licensing deal with VelaDx to develop sequencing-based oncology and infectious disease diagnostics on the Ion Torrent PGM platform.

The Singapore-based diagnostics firm plans to commercialize its first products on the PGM in the second quarter of 2014 and will seek global regulatory approval for its menu of tests.

VelaDx currently markets a range of clinical diagnostic PCR-based tests. Its automated Sentosa workflow system includes tests for influenza, norovirus, and hepatitis C and B viruses.

CEO Michael Tillmann told Clinical Sequencing News via email that the company is "working on moving existing real-time PCR tests, but also innovative biomarkers, onto the PGM."

He added that the company chose the PGM after doing a "thorough evaluation of turnaround time and [diagnostic] ability."

Additionally, he said the company will have full access to Ion Torrent's chips, including the 314, 316, and 318 chips, which will allow it to develop both smaller panels targeting just a handful of mutations, as well as larger panels as more biomarkers are validated in the future.

While in the near term VelaDx will "remain focused in our core areas of infectious disease and oncology," Tillmann said, having access to the full range of PGM products will "allow us to grow with market demands and new applications such as whole-exome or whole-genome sequencing."

VelaDx plans to seek regulatory approval for its tests, including clearance from the US Food and Drug Administration.

Life Tech has said that it plans to seek FDA 510(k) clearance for the PGM. Maneesh Jain, Ion Torrent's vice president of business development and marketing, told CSN that the company would not necessarily take the system through FDA clearance with one of VelaDx's tests, but that it would instead be a "parallel process."

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