"Gene Testing"

Navigenics Buys Clinical Lab From Affymetrix Last Month

Direct-to-consumer genetics testing vendor now has in-house laboratory testing capabilities

IF NAVIGENICS INC. HAD A SLOGAN to match its business model, it might be, “Damn the torpedoes. Full speed ahead!” Last month the personal genomics testing company acquired a clinical testing laboratory.

In a deal with Affymetrix, Inc., Navigenics purchased the Affymetrix Clinical Services Laboratory, a CLIA-certified testing facility in Sacramento, California. This lab provides molecular genome scanning using the Affymetrix GeneChip microarray platform. The purchase of this lab means Navigenics now can offer fully integrated genome screening and analysis under one roof.

Genetic Testing Service

As a direct-to-consumer company offering genetic tests to the public, it was just last year that Navigenics received a cease and desist order from the California Department of Health. The order said Navigenics was in violation of the California Business and Professions Code requirements that the company perform its tests in a clinically licensed facility, and that all of its lab test orders must be referred by either a physician or surgeon. It responded to the order by saying it did not actually test patients’ genomes; rather it analyzed them, according to Wired magazine. (See TDR, July 7, 2008.)

At the time, Wired reported that Navigenics was claiming it therefore should not be regulated as a clinical laboratory under California state law, arguing that it merely applies algorithms to DNA data it receives from tests performed by a third-party, a licensed laboratory.

It seems that Navigenics has adopted the philosophy of “it is better to join them than fight them.” The acquisition of Affymetrix’ clinical laboratory helps Navigenics comply with the California Department of Health letter.

Moreover, Navigenics had another motive to purchase a clinical laboratory. According to a report by GenoneWeb Daily News, Navigenics has experienced an increase in the volume of orders for its genetic screening services.

It recently began offering a less expensive genetics service. Also, Navigenics has a marketing partnership with MDVIP. This physician group, based in Boca Raton, Florida, runs a national network of individual physicians who practice preventive and personalized healthcare.

Business seems to be good for Navigenics. It has a research collaboration with The Scripps Translational Science Institute, Affymetrix, and Microsoft to genetically screen 10,000 participants. It will also continue to provide DNA scanning for Affymetrix customers, using the clinical laboratory it acquired from Affymetrix.

Navigenics is an example of a lab testing company developed outside of the traditional laboratory medicine estalishment. It represents a new sector in lab testing that is not controlled by pathologists.

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