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Complete Genomics Expects 'High Growth' for Translational, Clinical Business; CLIA License on Track

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By Julia Karow

Complete Genomics expects its business in translational and clinical research to grow in the future, and is preparing by planning new services, seeking CLIA certification, expanding its commercial staff, and appointing a genomic medicine advisory board.

"As much as there's been a shift toward outsourced human whole-genome sequencing in the research space, I think there's even more of a shift toward outsourced whole human genome sequencing in the translational and clinical space," said Complete CEO Cliff Reid.

Though most of the company's contracts for human whole-genome sequencing services are with academic and medical research centers at the moment, "we expect over the next year or two that could change quite significantly as our CLIA lab comes online and we enter the clinical sequencing business," Reid said.

Contracts like those with the Inova Translational Medicine Institute, announced last year (CSN 9/14/2011), and the Mayo Clinic's Center for Individualized Medicine, announced last month (CSN 2/15/2012), are "likely to be a very important and a very high-growth segment of our business," said Reid, and will be "one of the key focuses of our commercial organization." Reid made his remarks during a conference call to discuss the company's fourth-quarter earnings last week (see related story, with financial details, in this week's issue of In Sequence).

Part of the firm's current strategy is to enter the clinical market with the "most accurate whole human genomes in the industry," he said.

Toward this goal, the company plans to launch its long fragment read technology commercially for the clinical market in early 2013. The technique will allow customers to obtain haplotype information and will increase the data accuracy to an estimated Q70 value, or one error per million bases, Reid said.

Right now, the company is evaluating the LFR technology in more than 10 collaborations in order to optimize it further and to test potential applications, and is developing a process that will allow it to deploy the method on a large scale.

Complete is also working toward a two-week turnaround time for clinical customers by re-engineering parts of its automation process, another goal it hopes to achieve beyond 2012.

The company is making "good progress" toward CLIA certification and expects to obtain a license to operate a CLIA laboratory by mid year, Reid said. Many customers, including basic researchers, have been "very interested" in CLIA sequencing services, he said, perceiving it as independent validation of the quality and reproducibility of Complete's data.

For that reason, Reid said, the company plans to make CLIA sequencing "the mainstream of what we do" rather than "having one instrument off in the corner" dedicated to CLIA services.

The company also expects to diversify its service offerings further for the translational and clinical markets. Last year, it introduced a cancer sequencing service at $12,000 for a tumor/normal pair sequenced at high coverage (CSN 10/12/2011). "As we look out into the clinical markets, we see additional opportunities to differentiate products for different customers," Reid said. He provided no specifics on what these products will be.

The cancer sequencing service offering has been "very well received" and "remains a very important part of our business mix," Reid said. What differentiates Complete's cancer service from that of others is high data accuracy and software that has been modified specifically for the cancer genome, allowing customers to call different kinds of variants, he said.

On the commercial side, Complete grew its sales staff to 20 last year. Five of these focus on translational and clinical applications, and Reid said that the firm plans to grow its sales force further in that area.

Last month, the company also created a genomic medicine advisory board (IS 2/29/2012), which Reid said will "provide guidance" on how to deliver sequencing services best to healthcare organizations and physicians.


Have topics you'd like to see covered in Clinical Sequencing News? Contact the editor at jkarow [at] genomeweb [.] com.

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