Life Technologies plans to register its Ion Torrent PGM with the US Food and Drug Administration in the third quarter of this year, the company told Clinical Sequencing News at last week's Advances in Genome Biology and Technology meeting in Marco Island, Fla.
The registered version, which will be marketed as Ion PGM Dx, will include the company's AmpliSeq chemistry for library prep, template kits using 200-base pair chemistry, sample prep on the Ion One Touch 2 system, and the 318 chip, Alan Williams, VP of software and informatics at Ion Torrent, told CSN.
According to Williams, Life Tech is able to register the PGM Dx with the FDA, as opposed to applying for 510(k) clearance because Illumina's MiSeqDx already has 510(k) clearance, and the PGM Dx will have the same "intended use."
Additionally, Andy Felton, senior director of marketing at Ion Torrent, said that the company is not required to submit an assay with the system and does not plan to submit its own internally developed assay. Instead, it is working with a number of outside partners developing their own diagnostic assays on the PGM that they plan to submit to the FDA once the system is registered.
"We're working with partners that have specific tests that they are bringing through [FDA clearance] and they will leverage our reagents and then do an assay filing for their specific test," Felton said.
Felton said that all the "protocols are locked down" and that the company will do multi-site clinical trial work to validate production of the system and demonstrate reproducibility of a test panel across three sites, two of which are external.
Felton added that Life's process is different from the process Illumina went through to bring its MiSeqDx platform through FDA 510(k) clearance. Because there is already a 510(k) cleared next-gen sequencing system, additional systems can be registered with the FDA in a process that is more akin to CE marking in Europe.
Although the FDA gives guidance in terms of the design, process, and standards that are required, there is a lot of room for interpretation, making it important to be in discussion throughout the process, Felton said.
Molecular diagnostic companies or other groups that want to develop a diagnostic test on the PGM can "reference the master file as needed to support their submission" to the FDA, Williams said. Whether those assays would be 510(k) cleared or considered "registered," or if companies would have to bring them through pre-market approval, will "depend on the specific assay in question," he said.
The company declined to say whether it also plans to register the Proton with the FDA for diagnostic use, although it previously said that it would submit the system for 510(k) clearance.