Teterboro, N.J., December 11, 1998 Quest Diagnostics
Incorporated, a leading provider of diagnostic clinical testing, information and services,
announced that it has begun to offer the HercepTest assay, which was recently approved by
the U.S. Food and Drug Administration for use in testing breast cancer specimens. Quest
Diagnostics will market the HercepTest assay to physicians, hospitals and managed care
organizations.
The HercepTest assay is designed to identify patients who are likely to benefit from
HERCEPTIN® (trastuzumab), a new monoclonal antibody therapy for metastatic breast cancer
developed by Genentech, Inc. The test, which was approved by the FDA in September, was
developed by DAKO A/S in Copenhagen, Denmark and is distributed in the United States by
DAKO Corp., USA, based in Carpenteria, Calif.
It is estimated that in the United States 25 to 30 percent of approximately 180,700
women diagnosed annually with breast cancer produce excessive levels of HER2 protein.
Women diagnosed with breast cancer can be tested for this condition. Evaluation of a
patient's HER2 protein status, when added to the results of other tests and the patient's
overall condition, help oncologists determine the best treatment regimen for each woman.
The HercepTest assay enables a pathologist to detect high levels of the HER2 protein, and
qualify patients for treatment with Herceptin. The test can be performed on a new or
stored specimen of the tumor.
"We are very pleased that such a high quality reference laboratory as Quest
Diagnostics is offering the HercepTest assay," said Viggo Harboe, president of DAKO
Corp. "Quest Diagnostics Nichols Institute, where the test is performed, is an
ISO 9001 certified laboratory and its pathologists are extremely well qualified to perform
the test. Nichols Institute has over five years of experience in performing and
interpreting HER2 testing, and has offered breast cancer pathology services since the
early 1970s."
The Quest Diagnostics Oncology Center offers clients a telephone hotline to access the
expert consultation services of its medical and scientific staff, as well as its
prestigious Academic Associates, who specialize in the disciplines of oncology and
pathology. The Oncology Center is located at Nichols Institute, Quest Diagnostics
specialized laboratory and research and development center in San Juan Capistrano,
California. It can be reached at 1-800-NICHOLS ext. 2906.
DAKO is a leader in immunohistochemical testing for diagnosis of solid tumors and
develops, manufactures and sells diagnostic products for immunohistochemistry, molecular
pathology, flow cytometry, clinical immunochemistry and microbiology. The majority of DAKO
products are derived from the company's own research and expertise in antibody and probe
technologies. More company information is available on the Internet at: www.dakousa.com
Quest Diagnostics is one of the nation's leading providers of diagnostic testing,
information and services to physicians, hospitals, managed care organizations, employers
and government agencies. The wide variety of tests performed on human tissue and fluids
help doctors and hospitals diagnose, treat and monitor disease. Its Nichols Institute unit
conducts research, specializes in esoteric testing using genetic screening and other
advanced technologies, performs clinical studies testing, and manufactures and distributes
diagnostic test kits and instruments. Quest Informatics collects and analyzes laboratory,
pharmaceutical and other data to help large health care customers identify and monitor
patients who are at-risk for certain diseases. Additional company information can be found
on the Internet at: www.questdiagnostics.com