SAN ANTONIO, Dec. 14 /PRNewswire-FirstCall/ -- Clinicians will have a new
prognostic tool in the battle against breast cancer, as Quest Diagnostics
Incorporated (NYSE: DGX) announced today that it has introduced its newly
developed test, the Breast Cancer Gene Expression Ratio (HOXB13:IL17BR), to
help physicians predict the risk of disease recurrence in women with estrogen
receptor (ER)-positive, lymph node-negative breast cancer. Quest Diagnostics
is the first company to develop a breast cancer recurrence test based on
licensed gene-expression profiling technology from AviaraDx Inc., a molecular
cancer profiling company located in Carlsbad, California.
Launched at the San Antonio Breast Cancer Symposium, December 14 - 17,
2006, the Breast Cancer Gene Expression Ratio is based on the ratio of the
expression of two genes: the homeobox gene-B13 (HOXB13) and the interleukin-
17B receptor gene (IL17BR). In breast cancers that are more likely to recur,
the HOXB13 gene tends to be over-expressed, while the IL-17BR gene tends to be
under-expressed.
In an 852-patient retrospective study published recently in the Journal of
Clinical Oncology(1), Ma and colleagues found that the HOXB13:IL17BR ratio
(H:I expression ratio) independently predicted breast cancer recurrence in
patients with ER-positive, lymph-node negative cancer. The H:I expression
ratio was found to be predictive in patients who received tamoxifen therapy as
well as in those who did not.
The clinical value of the Breast Cancer Gene Expression Ratio also is
supported by a study published earlier this year in Clinical Cancer
Research(2). That study found that a high H:I expression ratio is associated
with an increased rate of relapse and mortality in ER-positive, lymph node-
negative cancer patients treated with surgery and tamoxifen.
According to the American Cancer Society (ACS), more than 210,000 cases of
breast cancer are diagnosed annually in the United States. Data from the
National Cancer Institute and ACS indicate that approximately half of these
cases -- about 100,000 women -- are diagnosed with ER-positive, node-negative
cancers(3). It is this group of patients who may benefit from H:I testing.
"Until recently, a patient's breast cancer prognosis depended on limited
variables, such as tumor size and grade, patient age, lymph node involvement
and hormone-receptor status," explains Richard A. Bender, M.D., F.A.C.P, Quest
Diagnostics' Medical Director for Oncology. "With the H:I measurement, we now
have more information to help predict the likelihood of disease recurrence in
patients with ER-positive, node-negative breast cancers. Physicians and
patients will want to consider this new information when deciding on treatment
options."
As the nation's leading provider of diagnostic testing, information and
services, Quest Diagnostics will provide Breast Cancer Gene Expression Ratio
testing to physicians through Quest Diagnostics Nichols Institute, the
company's esoteric testing laboratory in San Juan Capistrano, California,
which has validated the test.
"The Breast Cancer Gene Expression Ratio represents a significant advance
in personalized medicine in oncology," says Antonius Schuh, Ph.D., Chief
Executive Officer of AviaraDx Inc., the company that discovered and validated
the molecular markers used in the index. "As we identify prognostic biomarkers
in tumor types, we can further pinpoint and classify cancers so clinicians can
appropriately benefit from the promising new targeted cancer therapies and
make treatment decisions that may yield optimal outcomes for their patients."
The H:I two-gene expression ratio was developed as part of a clinical
research collaboration between Harvard Medical School and Massachusetts
General Hospital. The study that led to the discovery was designed to identify
prognostic biomarkers in breast cancer that provide new, independent
information as well as expand on standard clinical and pathological prognostic
markers. The collaboration results were published in June 2004 in Cancer
Cell(4).
About Quest Diagnostics
Quest Diagnostics is the leading provider of diagnostic testing,
information and services that patients and doctors need to make better
healthcare decisions. The company offers the broadest access to diagnostic
testing services through its national network of laboratories and patient
service centers, and provides interpretive consultation through its extensive
medical and scientific staff. Quest Diagnostics is a pioneer in developing
innovative new diagnostic tests and advanced healthcare information technology
solutions that help improve patient care. Additional company information is
available at: www.questdiagnostics.com.
About AviaraDx, Inc.
AviaraDx, Inc. is focused on developing and commercializing molecular
diagnostic technologies for personalized medicine in cancer treatment. The
company is targeting the oncology market with three first-in-class molecular
cancer profiling technologies: Molecular Cancer Identification (MCID), Breast
Cancer Profiling (BCP) and Drug Response Profiling (DRP). AviaraDX has
licensed its technologies for specific clinical indications to Quest
Diagnostics and other reference laboratories in the United States and Europe.
The statements in this press release that are not historical facts or
information may be forward-looking statements. These forward-looking
statements involve risks and uncertainties that could cause actual results and
outcomes to be materially different. Certain of these risks and uncertainties
may include, but are not limited to, competitive environment, changes in
government regulations, changing relationships with customers, payers,
suppliers and strategic partners and other factors described in the Quest
Diagnostics Incorporated 2005 Form 10-K and subsequent SEC filings.
(1) Ma X, et al. The HOXB13:IL17BR Expression Index Is a Prognostic
Factor in Early-Stage Breast Cancer. Journal of Clinical Oncology.
October 2006 24(28):4611-4619.
(2) Goetz, Matthew P, et al. A Two-Gene Expression Ratio of Homeobox 13
and Interleukin-17B Receptor for Prediction of Recurrence and
Survival in Women Receiving Adjuvant Tamoxifen. Clinical Cancer
Research. April 2006 12: 2080-2087.
(3) Swain SM. A step in the right direction. J Clin Onco 2006;24:3717-
3718.
(4) Ma, Xiao-Jun, et al. A two-gene expression ratio predicts clinical
outcome in breast cancer patients treated with tamoxifen. Cancer
Cell.June 2004 5: 607 - 616
SOURCE Quest Diagnostics
CONTACT: Nancy Fitzsimmons (Media): +1-201-393-5700, or Laure Park
(Investors): +1-201-393-5030
Web site: http://www.questdiagnostics.com