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Affymetrix Transfers Ownership of CLIA Lab to Navigenics

NEW YORK (GenomeWeb News) - Affymetrix recently decided to hand over ownership of its Clinical Laboratory Improvement Amendments-compliant lab to direct-to-customer genetic-testing firm Navigenics as part of a strategy to refocus on being a platform provider.

The move comes as an increasing number of drug makers outsource their molecular diagnostic research needs to CLIA labs.

An Affymetrix spokesperson told GenomeWeb Daily News sister publication BioArray News this week that Affy transferred ownership of its 10,000-square-foot Clinical Services Lab in Sacramento, Calif., to Redwoods Shores, Calif.-based Navigenics earlier this year.

Navigenics' DTC service uses a custom version of Affy's SNP 6.0 genotyping array, and the two firms have close ties. Navigenics' Chief Operating Officer Sean George was formerly vice president of marketing at Affy; General Counsel Stephen Moore previously held the same position at Affy; and board member Sue Siegel, who is now managing the firm, was formerly president at Affy.

The lab certified was CLIA compliant in April 2007 when Affy began to offer clinical trial and patient testing via gene expression monitoring, genotyping, chromosomal copy-number analysis, and other molecular diagnostics.

Affy said this week that it initially founded CSL because it "began seeing microarrays becoming a platform of choice in clinical settings and wanted to help qualify the use of the technology in this environment, as well as provide CLIA services on Affymetrix products to Affymetrix partners and customers."

The spokesperson said that those goals have now "been achieved as demonstrated by the success of Roche and Pathwork Diagnostics, which both have [US Food and Drug Administration]-cleared microarray-based tests on the market, and [Laboratory Corporation of America], one of the nation's largest CLIA lab service providers, which has leveraged microarrays as components of laboratory-developed tests."

According to the Affy spokeperson, in selling ACSL to Navigenics, the Santa Clara-based array vendor wanted to return its focus to its "core business objective of being an enabler for the broad adoption of microarrays across all genetic analysis markets, including CLIA lab services, to help all individuals benefit from understanding their own DNA.

"Our strategy in this area remains the same as it has always been," said the spokesman. "Affymetrix wants to enable the broader adoption of microarray technologies in all relevant markets, including clinical settings."

One of the ways Affy intends to do this is by "manufacturing high-quality, high-value products that can be leveraged not only by researchers, but also by CLIA lab service providers as individual components of laboratory developed tests."

For its part, Navigenics decided to acquire the clinical lab because the company has seen an increase in the volume of orders for its genetic screening service, according to Vance Vanier, Navigenics' chief medical officer.

The increase in testing volume may be attributed to the launch of a cheaper service offering, a marketing partnerships with a physicians group called MDVIP, and a research collaboration with The Scripps Translational Science Institute, Affymetrix, and Microsoft to genetically screen 10,000 participants.

Turna Ray, editor of GenomeWeb Daily News sister publication Pharmacogenomics Reporter, contributed to this article.

A more comprehensive version of this article appears in this week's issue of BioArray News. For additional coverage of Navigenics' purchase of the lab and that firm's strategy, see today's issue of Pharmacogenomics reporter.