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Illumina to Seek FDA Clearance, CLIA Certification in '09

NEW YORK (GenomeWeb News) - Illumina hopes to have a diagnostic assay cleared by the US Food and Drug Administration as well as a Clinical Laboratory Improvement Act-compliant laboratory operational by the middle of next year, according to a company official.
Greg Heath, senior vice president and general manager of the diagnostics business unit, told analysts at the San Diego firm’s analyst day, which was webcast, on Nov. 6 that the company will submit a test that runs on the digital microbead-based BeadXpress reader to the FDA in the first quarter of 2009.
“We expect FDA approval shortly thereafter; it could move into the second half of ’09, depending on how long the FDA takes with their clock,” he said.
Heath did not specifically discuss the targeted indication of the company’s first test, but said that “oncology is the sweet spot of growth in molecular diagnostics,” and he discussed ongoing research programs in ovarian and gastric cancer.
Health also said that Illumina will seek CLIA certification by the end of the second quarter. The company hopes to offer not only BeadXpress-based assays but also sequencing and array-based services.
According to Health, the CLIA lab is “essential” for rolling out Illumina’s pipeline of oncology tests. “Because of a long regulatory pathway, we want to be able to offer laboratory-developed tests earlier” through the lab, he said.
CEO Jay Flatley told GenomeWeb Daily News that Illumina also could offer array-based services through the lab, such as for its consumer genetics partners, 23andMe and Decode Genetics.
Illumina used to perform array-based services for 23andMe, but 23andMe switched to using Laboratory Corporation of America’s CLIA-compliant lab earlier this year after receiving warning letters from regulators in New York and California to stop marketing genetic tests directly to consumers. One of the reasons cited by regulators was that the consumer genomics firms were not licensed in these states to provide laboratory services.

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