GAITHERSBURG, Maryland, Aug. 26, 2013 /PRNewswire — GeneDx, one of the world’s foremost genetic testing laboratories and a wholly-owned subsidiary of Bio-Reference Laboratories, Inc. (NASDAQ: 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.
The turnaround time for OncoGeneDx tests is considerably faster than other offerings on the market allowing patients to use this information for treatment decisions including lumpectomy versus mastectomy and use of chemotherapy. Women with BRCA1/2 mutations have a 41-84% lifetime risk of developing breast cancer and up to a 63% lifetime risk of a second primary breast cancer, leading many BRCA1/2 carriers to choose more aggressive surgical options. BRCA1 carriers may also derive more benefit from the use of chemotherapy than the other women with an equivalently staged breast cancer. Mutations in TP53 are associated with increased risk of cancer when treated with radiation, and therefore mastectomy may be preferable over lumpectomy with radiation. BRCA1/2 testing results generally are reported in 7-10 days, and results for panel testing are reported in one month to allow patients and providers to precisely optimize cancer treatment.
There are also other types of cancer associated with a BRCA1 or BRCA2 mutation, including a significantly increased risk of ovarian cancer, prostate cancer, melanoma, and/or pancreatic cancer. BRCA1/2 carriers are recommended to have their ovaries removed after completion of childbearing because there are no effective methods to screen for ovarian cancer which is usually lethal. Prophylactic removal of the ovaries and Fallopian tubes is an effective method for reducing that risk of ovarian cancer.
Testing for inherited cancers is not indicated for all patients with cancer or even all those who have a family history of cancer. Characteristics of hereditary cancer include a family with multiple relatives with the same or related cancers, early age of cancer onset, the presence of multiple primary tumors, and/or bilateral cancer.
GeneDx is a leader in clinical genetic testing with more than 13-years experience and offers over 450 disease-specific tests as well as whole exome sequencing for all 20,000+ genes, and comparative genomic array. The laboratory has 35 board-certified geneticists and genetic counselors on staff available to address physician concerns and questions about genetic testing. To provide for patient educational needs, GeneDx will provide educational pre-testing videos and has genetic counseling service available by phone or video conference following testing.
The OncoGeneDx tests for inherited cancers are competitively priced, and GeneDx accepts all commercial insurances. To increase accessibility of the inherited cancer tests, the laboratory offers a compassionate care program for patients on Medicaid or those who pay out of pocket for the test and can demonstrate financial hardship.
Minimizing Variants of Uncertain Significance (VUS)
A small percentage of patients (about 5%) who undergo genetic testing for BRCA1 and BRCA2 receive a variant of uncertain significance (VUS) result, indicating a genetic sequence change with an unknown association with cancer risk. To minimize the rate of VUS and to facilitate data gathering for reclassification of the inconclusive variants, GeneDx has its own database with more than 4,000 reference sequences and is adding at the rate of 150+ individuals/week to this database. Further, GeneDx shares de-identified data with publicly curated databases such as ClinVar, the genetic data repository of the National Center for Bioinformatics at NIH, believing that both the medical community and patients benefit from making this information freely available. There are currently over 5,000 genetic variants in BRCA1 and BRCA2 stored in ClinVar, and clinical labs such as GeneDx can access this curated data to improve interpretation of patient results.
About Bio-Reference Laboratories Inc. (NASDAQ:BRLI) and GeneDx
BRLI is the fourth largest full service laboratory in the United States, primarily a clinical testing laboratory servicing physician offices with concentrations in the focused markets of esoteric testing, molecular diagnostics, anatomical pathology, women’s health and correctional health care. GeneDx, a wholly owned subsidiary, is the BRLI genetics laboratory and is typically recognized as the leading laboratory for testing of rare genetic diseases; GeneDx has now become a technology leader with XomeDx, whole exome sequencing test, and its Next-Gen sequencing offerings that are currently offered in several disease areas, such as cardiology, neurology, immunology, ophthalmology and prenatal areas.
Statements included in this release that are not historical in nature, are intended to be, and are hereby identified as “forward-looking statements”. Forward-looking statements may be identified by words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning and include, but are not limited to, statements about the expected future business and financial performance of Bio-Reference Laboratories, Inc. and its subsidiaries. Statements looking forward in time are included in this release pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made and which reflect management’s current estimates, projections, expectations or beliefs and which involve risks and uncertainties that could cause actual results and outcomes to be materially different. Risks and uncertainties that may affect the future results of the company include, but are not limited to, adverse results from pending or future government investigations, lawsuits or private actions, the competitive environment, changes in government regulations, changing relationships with customers, payers, suppliers and strategic partners, the ability to enhance the future growth and expansion of GeneDx and its service and product offerings and other and other risks and uncertainties detailed from time to time in our filings with the Securities and Exchange Commission. We undertake no obligation to publicly update or review any forward-looking information, whether as a result of new information, future developments or otherwise.