OvaGene's new molecular diagnostics laboratory receives CLIA-certification

Sep 20 2011

OvaGene Oncology Inc., a molecular diagnostics company specializing in the development and commercialization of personalized gene-based diagnostics for gynecologic cancer, announced today that the company has received Clinical Laboratory Improvement Act (CLIA) certification for their newly constructed state-of-the-art molecular diagnostics laboratory.  The OvaGene laboratory is now fully-licensed to receive patient clinical specimens from Gynecologic Oncologists across most of the nation.

"CLIA-certification is a significant step forward for OvaGene. We are excited to now be able to bring OvaGene's innovative gene-based assays directly to Gynecologic Oncologists and their patients," commented Denise Chua, MBA, Vice-President of Clinical Operations and Marketing. "The licensure of OvaGene's clinical laboratory is just the first step in providing Gynecologic Oncologists with the latest molecular tools to help guide treatment decisions.  Expertise in advanced molecular diagnostics testing and strong relationships with key healthcare centers and physicians within the gynecologic community will prove to be valuable in the successful commercialization of OvaGene's gene-based diagnostics."

Frank Kiesner, JD, Chairman and CEO, added, "The opening of OvaGene's CLIA-certified clinical laboratory is an important milestone for our company. The clinical laboratory will become the company's primary channel through which we will bring innovation to the bedside of gynecologic cancer patients. 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."

OvaGene plans to launch a series of gene-based profile assays over the next couple of months for ovarian, endometrial and cervical cancers.  The initial tests include a proprietary protein expression assay for the prediction of recurrence in early stage endometrial cancers and two gene-based profile panels: gynecologic cancer targeted therapy assessment and endometrial cancer recurrence/drug response assessment.  OvaGene plans to make these assays, and other complementary tests, commercially available in October 2011.