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Complete Genomics Expects CLIA Certification This Year, Long Fragment Read Tech by 2013

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This story was originally published May 8.

Complete Genomics expects to be CLIA certified this year and to launch its long fragment read technology, which will enable whole-genome haplotyping, by 2013, the company said this week in a conference call to discuss its first-quarter earnings.

Additionally, CEO Cliff Reid said that the company's new ability to use saliva samples will further open up the clinical market, particularly for children with idiopathic diseases. Complete announced in March that it would partner with DNA Genotek to use the company's Oragene products for non-invasive saliva collection.

Reid said he anticipates the whole-genome sequencing market will eventually be "bifurcated" between research and clinical applications, with clinical-grade genomes commanding "premium prices."

Reid said that the company is in the process of preparing to submit a CLIA application, which it plans to do in the third quarter of this year.

To do that, he said, the company is completing three major steps. First, it is modifying its quality-management system to be fully compliant with CLIA rules and regulations. Second, California, the state in which it operates, has its own regulations regarding personnel, so Reid said the company would have to bring in additional certified personnel to operate the CLIA lab. And finally, the company is working with researchers from the Mayo Clinic on a validation assay to demonstrate reproducible and high quality whole-genome sequence data.

The company's long fragment read technology, targeted for a 2013 launch, will be another key driver of the company's clinical business, said Reid. The technology will allow customers to obtain haplotype information and will also increase data accuracy to Q70, or one error per million bases, Reid said.

Reid said he expects the company's clinical business to be "significantly larger" than the research business in the long term.

He anticipates that the dynamic in the clinical market will "parallel the dynamic of the research business," with customers starting with pilot projects and then scaling up from there, with a couple of key differences.

Negotiating those contracts will be a much longer, more drawn-out process. "It's a complex sale to sell to a healthcare system or a hospital network" as compared to selling to a principal investigator with a grant, he noted.

However, he said, clinical projects will ultimately be much larger than projects done in a research setting. For instance, the 1,500-genome project that Complete is doing with the Inova Translation Medicine Institute (CSN 9/14/2011) is still in the pilot phase, and Inova expects to scale up from there.

"The large healthcare systems and large hospital networks that are looking over the coming years to sequence patients initially for discovery projects and ultimately for patient care — the number of samples per system is very high compared to the number of samples you encounter in a research setting," said Reid. These centers "measure the number of patients they see in the tens of thousands."

And while these transactions will likely take years to unfold, "we see a high degree of interest" and the "opportunity to sequence large numbers of patients," he added.

Reid did not disclose any potential clinical customers, but said that they would be announced when the deals were signed.

He predicted that early clinical opportunities would be for children with idiopathic disease as well as cancer patients and that the market would expand to other diseases over time.

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