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OvaGene Lab Receives CLIA Certification

NEW YORK (GenomeWeb News) – Molecular diagnostics firm OvaGene on Monday announced its laboratory has received Clinical Laboratory Improvement Act certification, making it fully licensed to receive patient clinical specimens from gynecological oncologists from most of the US.

Based in Irvine, Calif., OvaGene develops gene-based diagnostics for gynecological cancer.

Frank Kiesner, chairman and CEO of OvaGene, said the certification marked a milestone for the company.

"The clinical laboratory will become the company's primary channel through which we will bring innovation to the bedside of gynecologic cancer patients," he said in a statement. "As our advanced in-house research continues, additional proprietary gene-based tests will migrate into our clinical laboratory, allowing us to introduce a focused and comprehensive collection of assays created specifically for the gynecologic cancer patient."

The company said it plans launch profile assays in the next few months targeting ovarian, endometrial, and cervical cancers. The initial tests include a protein expression assay to predict recurrence in early stage endometrial cancers. It also will launch a gene-based profile panel for gynecologic cancer-targeted therapy evaluation and a gene-based assay for assessing endometrial cancer recurrence/drug response.

These and complementary tests are expected to launch in October.

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