Press Release Details

Quest Diagnostics is First National Clinical Laboratory to Provide FDA-Approved HercepTest™ Breast Cancer Assay


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 1970’s."

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:

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: