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VelaDx to Launch CE-IVD Marked NGS Workflow with Clinical Assays on PGM this Summer

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NEW YORK (GenomeWeb) – VelaDx this year plans to launch next-generation sequencing workflows on Life Technologies' Ion Torrent PGM platform with CE-IVD oncology and virology assays.

The company will market and sell the entire workflow, which includes the PGM system, its Sentosa SX101 automation platform, necessary reagents for specific assays, and bioinformatics, as a "turnkey solution" for clinical customers, VelaDx CEO Michael Tillman told Clinical Sequencing News.

The company will launch the system first in Europe as a CE-IVD marked device in the third quarter followed by a launch in Australia in the fourth quarter.

VelaDx and Life Tech, now part of Thermo Fisher Scientific, struck a supply and licensing deal in 2012. Tillman said that although VelaDx's workflow will use the PGM, the company is not simply plugging the sequencer into the workflow. Instead, Life Tech will continue to manufacture the PGM instrument, but it will be designed according to VelaDx's specifications and will have the VelaDx label, Tillman said.

Initially, 15 sites will be early access customers and the company is planning to launch seven assays by the end of 2015. Its first assay will be a melanoma panel consisting of 10 genes that will launch in Q3 with CE-IVD marking in Europe. The first instruments are already installed, Tillman said, and all 15 early access customers will have their systems up and running by the end of July.

Aside from the melanoma panel, the firm is also developing HCV and HIV genotyping assays, an 11-gene colon cancer panel, a 10-gene non-small cell lung cancer panel, a thyroid cancer panel, and a leukemia panel.

The oncology assays will require 10 ng of starting DNA and will be able to detect mutant alleles down to a 5 percent frequency. The detection sensitivity for the virology assays will be 1,000 IU/ml. Each assay is sequenced to 1,000-fold coverage.

For library prep, VelaDx will integrate its Sentosa SX 101, a liquid handling system that performs DNA extraction, PCR setup, and library prep for either a qPCR assay or an NGS assay. One sample can be assessed via both methods, and the results can be merged in the patient report.

The NGS assays will all be based on Life Tech's AmpliSeq technology, and VelaDx has developed the reporting and interfacing software, Tillman said.

The firm plans to publish validations of its assays and will also publish its workflow, which it expects will be available in the third-quarter this year when the system launches. In total, it has tested more than 1,000 formalin-fixed paraffin-embedded samples.

VelaDx eventually would like to bring the workflow through US Food and Drug Administration clearance, Tillman said.

The FDA last year cleared Illumina's MiSeqDx system along with two cystic fibrosis assays and a universal kit — the first time an NGS system has received 510(k) clearance. Life Tech has previously said that it would not need to go through the same intensive 510(k) clearance process for the PGM since it would have the same intended use.

However, Tillman told CSN that because multi-gene oncology assays are more complex than a cystic fibrosis test, and because the system also includes an entirely automated workflow, the FDA's requirements may be different. The firm is in discussion with the FDA about its requirements, he added.

The FDA's Elizabeth Mansfield has indicated that an NGS system with an assay designed to sequence tumor tissue would not fall under the same intended use as the MiSeqDx. Speaking at the American Association for Cancer Research in April, she said that the MiSeqDx has a Class II exempt status, meaning that other companies developing systems with the "same intended use" do not have to go through the same 510(k) clearance process, but have to abide by special controls the FDA put in place. However, she said that "same intended use" is limited to targeted sequencing of DNA from blood, not tumor tissue.

Tillman said that he anticipates the first customers will be university hospitals and pathology labs in Europe. In addition, he thinks many of VelaDx's existing customers will want to switch to NGS from qPCR. Because the workflows are both integrated with the Sentosa system, upgrading the qPCR customers to NGS would be relatively straightforward, he said.

VelaDx did not disclose the price of the system.

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