GAITHERSBURG, Md. , Aug. 26, 2013 /CNW/ - GeneDx, one of the world's foremost genetic testing laboratories and a wholly-owned subsidiary of Bio-Reference Laboratories, Inc. (BRLI) has announced the launch of a comprehensive suite of genetic tests for inherited cancer, including a 26-gene panel for breast and ovarian cancer that includes BRCA1 and BRCA2 and next generation sequencing based multi-gene panels for colorectal cancer, pancreatic cancer, and endometrial cancer.

GeneDx, the first commercial laboratory to utilize next generation sequencing technologies in a CLIA-environment, is among only a handful of commercial labs in the U.S. currently offering testing for inherited cancer. The laboratory will begin accepting specimens immediately.

The test offerings include a rapid turn-around test of the BRCA1 and BRCA2 genes combining sequencing and deletion/duplication analysis; an Ashkenazi Jewish panel for the three common Ashkenazi Jewish founder mutations in BRCA1 and BRCA2; a 26-gene panel for breast and ovarian cancer; an 18-gene panel for pancreatic cancer; an 18-gene panel for colorectal cancer; and an 11-gene panel for endometrial cancer. The test panels, which are marketed as OncoGeneDx, also include a Comprehensive Cancer Panel of 35 genes. All panels include deletion/duplication assessment.

The OncoGeneDx panels utilize the most current data on all the highly penetrant genes associated with inherited cancer, providing rapid results at typically no greater cost than testing for a single gene. GeneDx's OncoGeneDx panels are the most comprehensive on the market today.

Sherri Bale , Ph.D., Managing Director of GeneDx stated, "We are excited to be launching this suite of tests, as we can now bring our extensive experience in genetic testing along with cutting-edge technologies to bear on this very important public health problem that has tremendous impact on patients and their families. They deserve the best that the genetic testing community can provide them, and we are able to do that."

Marc Grodman M.D ., Bio-Reference CEO, announced, "The mission of GeneDx is to help clinicians diagnose complex inherited diseases in an efficient manner. It is part of a larger vision to reconcile technological and scientific advances in testing with our long-standing commitment to appropriate genetic medicine. The introduction of our inherited cancer panels is a natural progression in our ongoing dedication to providing better solutions for both clinical genetic diagnostics and cancer care.

We focus on offering clinically relevant gene panels based on the patient's cancer and family history and provide comprehensive testing to allow patients and their providers to have the most accurate information to guide cancer treatment and prevention. In addition, we are not limited to a single technology for mutation detection. We use all appropriate technologies necessary to answer the clinical question."

Although BRCA1/2 gene sequencing has been available for many years, comprehensive evaluation for deletions and duplications in those genes was launched only recently and has not been available to many patients due to payer restrictions. The OncoGeneDx panels include deletion/duplication analysis of genes in each panel at no additional charge. "Among patients with breast cancer and a significant family history of cancer who test negative for BRCA1 and BRCA2, approximately 12% can be expected to carry a large genomic deletion or duplication in one of these genes. Effective methods for identifying these mutations should be made available to women at high risk," as reported by Walsh T., et al (JAMA, 2006).

Patients who previously had BRCA1/2 testing can now get a "second opinion" to confirm their test results. Second opinion testing may be helpful for women considering prophylactic removal of healthy organs to reduce the risk of cancer, as well as for women who have received an ambiguous result from previous testing or normal results with a strong family history of breast and ovarian cancer.

The OncoGeneDx Breast/Ovarian next-generation sequencing panel is the most comprehensive test available today for patients with hereditary breast/ovarian cancer, including all known genes with a significant risk for hereditary breast or ovarian cancer. This test may be useful to patients who previously had normal BRCA1/2 test results with a significant family history of breast or ovarian cancer.

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GeneDx Introduces Advanced Genetic Test Panels for Inherited Cancer Including Breast and Colon Cancer

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