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AltheaDx Gets CLIA Certification in California

NEW YORK (GenomeWeb News) – AltheaDx, a San Diego-based firm developing companion diagnostics, said on Thursday that it has received Clinical Laboratory Improvement Amendments (CLIA) certification from the State of California.

The firm said that it would immediately begin providing clinical genotyping services from the CLIA lab for the KRAS gene, as well as other "high-value" molecular tests. The lab is located in Sorrento Valley, San Diego.

In November 2008, AltheaDx inked an agreement to offer as a service DxS' genetic assay for KRAS mutations for use in clinical studies in the US.

"We are now able to extend our success into later stage clinical trials and provide broader market access for our assays," David Macdonald, CEO of AltheaDx, said in a statement. "Our CLIA certification is an important milestone in realizing our strategy of bringing theranostics into clinical use."

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