BURLINGTON, N.C.--(BUSINESS WIRE)--Jan. 18, 2012--
Laboratory Corporation of America® Holdings (LabCorp®)
(NYSE: LH) announced today the nationwide availability of a new FDA
cleared risk stratification tool (ROMA®, Risk of Ovarian
Malignancy Algorithm) that combines the results for
Fujirebio HE4, Abbott’s ARCHITECT® CA 125 II, and
menopausal status into a numerical score that, along with clinical and
radiological evaluation, can aid in evaluating whether a woman over the
age of 18 who presents with an ovarian mass and for whom surgery is
planned is at high or low likelihood of finding malignancy on surgery.
Approximately 300,000 women present with a pelvic mass every year, and
an overwhelming percentage of those masses are diagnosed as benign. The
American College of Obstetricians and Gynecologists Practice Bulletin
published in July of 2007 (Bulletin #83) states that “Women with ovarian
cancer whose care is managed by physicians who have advanced training
and expertise in the treatment of women with ovarian cancer, such as
gynecologic oncologists, have improved overall survival rates compared
with those treated without such collaboration.” Therefore, there is a
need for an accurate and specific risk stratification tool to assess
malignancy in these women to help ensure they receive the best possible
treatment.
The symptoms of ovarian cancer that are related to the presence of
masses are often vague and unspecific. The primary goal of diagnostic
evaluation of an adnexal mass is to determine whether it is benign or
malignant. ROMA provides equal sensitivity to other commercially
available risk stratification tools while improving the specificity for
determining the risk level of malignancy. “ROMA is an important
additional tool for physicians to have to aid in the risk stratification
of their patients,” said Dr. Mark Brecher, LabCorp's Chief Medical
Officer. “When used in conjunction with clinical exam and radiological
studies, it will assist patients in receiving the most appropriate
referrals.”
ROMA is intended to aid in assessing whether a premenopausal or
postmenopausal woman who presents with an ovarian adnexal mass is at
high or low likelihood of finding malignancy on surgery. ROMA is
indicated for women who meet the following criteria: over age 18,
ovarian adnexal mass present for which surgery is planned, and not yet
referred to an oncologist. ROMA must be interpreted in conjunction with
an independent clinical and radiological assessment. The test is not
intended as a screening or stand-alone diagnostic assay. Incorrect use
of ROMA carries the risk of unnecessary testing, surgery, and/or delayed
diagnosis.
About LabCorp®
Laboratory Corporation of America® Holdings, an S&P 500
company, is a pioneer in commercializing new diagnostic technologies and
the first in its industry to embrace genomic testing. With annual
revenues of $5.0 billion in 2010, over 31,000 employees worldwide, and
more than 220,000 clients, LabCorp offers a broad test menu ranging from
routine blood analyses to reproductive genetics to DNA sequencing.
LabCorp furthers its scientific expertise and innovative clinical
testing technology with its Centers of Excellence: The Center for
Molecular Biology and Pathology, National Genetics Institute, ViroMed
Laboratories, Inc., The Center for Esoteric Testing, Litholink
Corporation, Genzyme GeneticsSM*, DIANON Systems,
Inc., US LABS, Monogram Biosciences, Inc., and Esoterix and its Colorado
Coagulation, Endocrine Sciences, and Cytometry Associates laboratories.
LabCorp conducts clinical trials testing through its Esoterix Clinical
Trials Services division. LabCorp clients include physicians, government
agencies, managed care organizations, hospitals, clinical labs, and
pharmaceutical companies. To learn more about our organization, visit
our Web site at: www.labcorp.com.
*Genzyme Genetics and its logo are trademarks of Genzyme Corporation
and used by Esoterix Genetic Laboratories, LLC, a wholly-owned
subsidiary of LabCorp, under license. Esoterix Genetic Laboratories and
LabCorp are operated independently from Genzyme Corporation.
ROMA is a registered service mark, and CA 125 II is a trademark, of
Fujirebio Diagnostics, Inc.
ARCHITECT is a registered trademark of Abbott Laboratories.
This press release contains forward-looking statements. Each of the
forward-looking statements is subject to change based on various
important factors, including without limitation, competitive actions in
the marketplace and adverse actions of governmental and other
third-party payors. Actual results could differ materially from
those suggested by these forward-looking statements. Further information
on potential factors that could affect LabCorp’s financial results is
included in the Company’s Form 10-K for the year ended December 31,
2010, and subsequent SEC filings.
Source: Laboratory Corporation of America(R) Holdings
Laboratory Corporation of America® Holdings
Stephen
Anderson, 336-436-5274
www.labcorp.com
