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Claritas Looks to Expand NGS Test Menu, Partners with Cerner to Develop LIMS for NGS Dx

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Claritas Genomics, a genetic diagnostic company that was spun out of the Boston Children's Hospital in February 2013, last week said it would partner with Cerner to co-develop a laboratory information management system designed specifically for genomic data from next-generation sequencing-based tests.

Claritas currently offers 110 genetic tests, most of which are based on Sanger sequencing and were developed at Boston Children's Hospital Genetic Diagnostic Laboratory, but it also offers a muscular dystrophy sequencing panel based on next-gen sequencing, and Nurjana Bachman, the company's chief business officer, told Clinical Sequencing News that going forward all tests will be based on next-gen sequencing. Future tests will focus on inherited pediatric disorders, including a clinical exome test and comprehensive panels for phenotypically defined syndromes, Bachman said.

The company received an initial investment from Life Technologies and is a certified service provider for exome sequencing on the Ion Proton. Bachman said that as part of that investment, the company has a "focus on optimizing our testing on the Life platforms," but that it also has "access to multiple platforms in our facility," although she declined to disclose which and how many platforms from other vendors Claritas owns.

Upon its launch, Life Technologies CEO Greg Lucier said Claritas would be equipped with four Ion Proton machines and four PGMs.

Bachman said that the agreement with Cerner has several components. The companies will codevelop LIMS for clinical labs using next-gen sequencing tests. And, as a first phase of that process, Claritas will use Cerner's Millenium Helix LIMS.

Additionally, Cerner's wholly owned subsidiary Cerner Capital has invested in Claritas, becoming a minority shareholder, and bringing Claritas' Series A financing round to a close. In addition, Clay Patterson, managing director of Cerner Capital, has joined the Claritas board of directors. Claritas' other investors include Life Tech, Boston Children's Hospital, and the Cincinnati Children's Hospitals.

Finally, Claritas will join Cerner's Reference Lab Network, enabling other network partners to order tests from Claritas. Currently, there are 16 labs listed on Cerner's website as partners in the Reference Lab Network, including Quest and Laboratory Corporation of America. Additionally, ARUP and Mayo are both listed as being connected to the network.

While Cerner's Helix LIMS was developed for molecular data and genetic information, Bachman said that "next-generation sequencing is a much more complicated workflow in a laboratory than existing [genetic] tests" that are often single-gene tests or even small panels. The system that Claritas and Cerner develop will be designed to handle exome and whole-genome sequencing tests, which provide not only more, but also more complex information than single-gene tests, Bachman said.

"We're talking about exomes or genomes worth of information that has to be tracked through a laboratory information system … all the way from the time an order is placed to [when] a result is returned and a bill provided," she said.

Additionally, she said, the companies will work to make sure the data can be integrated into electronic medical records.

The companies plan to begin testing a version of the new system at Claritas next year, with a full commercial launch expected in 2015.

Bachman said that the third component of the partnership — joining Cerner's Reference Lab Network — could help increase Claritas' genetic testing business by making it easier for laboratories to order its tests.

"From a logistics standpoint it makes it very easy for hospitals to order from us and get results returned," she said. The process "becomes seamlessly integrated into the systems of other hospitals."

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