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Life Tech Bets on NGS for Pediatric Dx via Boston Children's Spinout as it Continues Drive into Clinical Market

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This article was originally published Jan. 8.

SAN FRANCISCO — Life Technologies said this week that it is partnering with Boston Children's Hospital spinout Claritas Genomics to develop diagnostics on Life's Ion Torrent platforms for inherited pediatric diseases.

Additionally, during a presentation at the JP Morgan Healthcare conference here, CEO Greg Lucier said that around 20 percent of its 2012 Ion Torrent sales were to clinical customers and that the company expects that number to ramp up dramatically in 2013.

Claritas Genomics will initially be equipped with four of Life's Ion Proton machines and four PGMs. Lucier told Clinical Sequencing News that the new company's initial offering will be an inherited disease panel that will be similar to the Ion AmpliSeq Inherited Disease Panel that is composed of 10,500 amplicons targeting 300 genes involved in over 700 diseases. Life markets that kit for research use only, and a clinical version will be slightly different and "unique" to Claritas, but Lucier did not elaborate.

Initially, Claritas will screen all patient samples it receives with this panel, Lucier said. Eventually the company plans to move into whole-exome or whole-genome sequencing for some patients as well as develop targeted sequencing panels for specific diseases.

Claritas plans to validate the Proton for clinical use and will develop diagnostic tests for carrier screening, prenatal diagnostics, and post-birth diagnostics for pediatric diseases, including rare disorders and pediatric cancers, Lucier said.

The company will be its own institution, separate from Boston Children's Hospital, which is the majority owner of the for-profit entity. Additionally, all the genetic tests currently being run out of BCH's CLIA genetic laboratory will be moved over to Claritas, Lucier said. Lucier said that the reason for spinning out a separate company as opposed to simply running the sequencing-based diagnostics through BCH's CLIA laboratory is to encourage additional collaborations with other children's hospitals.

"The goal is to bring in other children's hospitals either as equity owners or franchisees," he said. Other hospitals could either come on board as co-owners or a similar model could be used to combine Life's technology with the clinical expertise of a children's hospital to form a new entity, he explained.

David Margulies, executive director of the Gene Partnership at Boston Children's Hospital, said in a statement that Claritas represents a "practical paradigm for taking genetic and genomic research discoveries to the bedside."

"We're excited to be able to scale up and offer this capability to patients everywhere," he added. "Through a set of network collaborations and via electronic communications, we plan to provide interpretive services around the world."

Life Tech will have a 20 percent stake in Claritas and the management team will be drawn from both BCH and Life Tech, Lucier said. He did not disclose other financial details.

The deal builds on a collaboration announced in June between Life Tech and BCH to develop next-generation sequencing workflows for the Proton in a CLIA- and CAP-certified laboratory. Around the same time, Life Tech announced a similar partnership with the Hospital for Sick Children in Toronto (CSN 6/27/2012).

The SickKids Hospital established a separate Center for Genetic Medicine and also ordered four Proton machines to do exome sequencing and eventually whole-genome sequencing on its pediatric patients.

During a presentation at the JP Morgan Healthcare conference this week, Lucier provided further details on the company's efforts in clinical sequencing. In 2012, around 20 percent of Ion Torrent sales were to clinical customers, Lucier said, and in 2013, "that number will ramp up dramatically."

Additionally, the company has developed a focused CLIA sales channel as well as a focused clinical trials channel. The CLIA sales channel will work with labs that are doing clinical research to explain how Life's array of tools could best suit their needs, including not just the Ion Torrent sequencing systems, but also the firm's CE sequencing instruments and PCR platforms. The clinical trials channel will work similarly with pharmaceutical companies, as clinical trials become "ever more oriented toward genetics," Lucier said.

The company is also planning to submit its Ion Torrent PGM machine to the US Food and Drug Administration for 510(k) clearance this year. Originally, it had said that it would submit the platform in 2012, but during a question-and-answer session following the JP Morgan presentation, Mark Gardner, Life's general manager of advanced genomic systems, said that the company wanted to make sure the company had "improved the performance of the PGM to a point where we were comfortable locking it down."

He said not only will Life Tech seek 510(k) clearance in the US, but also CE-IVD approval in Europe, China, and other countries.

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