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Sciona Gains CLIA Lab Certification for Personal Genetics Service

NEW YORK (GenomeWeb News) – Personal genetics company Sciona said today that the Centers for Medicare & Medicaid Services has certified its laboratory under the Clinical Laboratories Improvement Act.
Sciona was among 13 genetic-testing firms that received cease-and-desist letters from the state of California last month because their offerings were not in compliance with the state’s laws, which require that labs have a CLIA certificate and a license to operate as a clinical laboratory in California. In addition, the state said that all genetic tests must be ordered by a licensed physician.
Sciona, based in Aurora, Calif., said today that its CLIA lab uses Illumina’s genotyping technology and is “devoted solely” to processing its personalized genetics products, which include a service called “mycellf,” which offers customers information on how their genetic makeup affects metabolism, diet, nutritional processing, and lifestyle.
The company said in a statement that its genetic testing products “address personal wellness, fitness, and nutritional issues” and that it “does not provide medical, diagnostic or specific disease related information.”
“Receiving the CLIA certification as a high complexity laboratory is a major milestone for the company and its future," said Sciona CEO and President Peter Vitulli in a statement.

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