GeneDx Introduces Advanced Genetic Test Panels for Inherited Cancer Including
Breast and Colon Cancer
GAITHERSBURG, Maryland, Aug. 26, 2013
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
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
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.
For more information on the GeneDx inherited cancer testing services, please
visit www.genedx.com/oncology or www.OncoGeneDx.com .
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.
Contact: Karen Maurer, +1-201-470-1029, firstname.lastname@example.org
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