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Quest Diagnostics Introduces New Cytopathology Procedure For Early Breast Health Evaluation

03/07/1

TETERBORO, N.J., March 7 /PRNewswire/ -- Quest Diagnostics Incorporated (NYSE: DGX), the nation's leading provider of diagnostic testing, including anatomic pathology services, and ProDuct Health, Inc., a provider of medical devices to fight breast cancer, announced that Quest Diagnostics is the first commercial reference laboratory to accept "ductal lavage" specimens for analysis. Ductal lavage is a procedure for collecting pre-cancerous and cancerous cells from milk ducts in the breast, the source of most breast cancer.

ProDuct's ductal lavage procedure is based on decades of research showing that most breast cancer begins in the cells lining the milk ductal system of the breast. By collecting these cells directly from the milk ducts, the minimally invasive ductal lavage procedure functions somewhat like a "Pap smear" for the breast, allowing the early detection of pre-malignant and malignant cells from their source of origin. Just as Pap tests are used to identify significant precancerous cervical disease, ductal lavage gives physicians and their patients additional information to make decisions about management and therapeutic options. Breast cancer is a leading cause of death for women.

The devices used in the ductal lavage procedure have been cleared by the FDA for medical use. The procedure will be used as a way to assess risk among a group of women who are already at high risk for breast cancer. It is not recommended as a general screening approach for all women.

Cytopathologists at Quest Diagnostics have been specially trained on the clinical interpretation of breast ductal fluid samples obtained using ProDuct's InDuct(TM) Breast MicroCatheter and InDuct(TM) Breast Aspirator. Only physicians on Quest Diagnostics' medical staff who have been trained jointly by ProDuct Health and Dr. Britt-Marie Ljung, Professor of Pathology, from the University of California, San Francisco, will review ductal lavage specimens. Dr. Ljung was the lead pathologist in the ProDuct Health clinical trial and has evaluated over a thousand ductal lavage specimens. Nine of Quest Diagnostics' regional laboratories now have trained staff and can handle ductal lavage specimens, using the non-gynecological ThinPrep(R) filtration process as the company's standard process for preparing the specimens for microscopic slide review.

As an established Cytopathology process, the breast ductal lavage laboratory diagnosis is currently covered by Medicare and most private health care plans.

"The ability to look for the very beginnings of abnormal change in the breast can offer important information for physicians to consider in the management of women at high-risk for breast cancer," said Dr. Dwight DeRisi of Long Island Breast Care in Great Neck, N.Y. "The availability of ductal lavage interpretation through Quest Diagnostics will give us efficient, reliable access to this information."

Specimens are collected using the InDuct(TM) Breast MicroCatheter and InDuct(TM) Breast Aspirator, made by ProDuct Health. This is a method for collecting cells within breast ducts for cytologic analysis and interpretation. ProDuct Health distributes its product to trained medical professionals, primarily breast cancer surgeons and others involved with the detection and treatment of breast cancer and the reduction of breast cancer risk. The system of products enables physicians to collect cells from the lining of the breast milk ducts for cytological analysis, and allows the determination of normal, pre-malignant and malignant cells.

"Ductal lavage enables our Cytopathologists to search for pre-malignant cells in the breast, just as we have done with cervical specimens for decades," said Harvey W. Kaufman, M.D., Vice President and Chief Laboratory Officer for Quest Diagnostics. "It is an exciting advance that gives women and their physicians options for prevention and treatment when used as an adjunct to standard breast cancer detection methods such as mammography or a physical exam."

About ProDuct Health

Founded in 1998, ProDuct Health, Inc. is a privately held company based in Menlo Park, CA. ProDuct Health's mission is to eradicate breast cancer through the earliest detection and treatment of breast pre-cancer and cancer. Centers offering ductal lavage and accepting referral patients are listed on the ProDuct Health web site (http://www.producthealth.com) and through the company's toll-free information line 1-866-466-DUCT (866-466-3828).

About Quest Diagnostics

Quest Diagnostics is the leader in anatomic pathology services and in women's health diagnostics. Quest Diagnostics was the first laboratory to offer the HercepTest nationally for HER2 breast cancer testing, first to offer human papillomavirus reflex testing off a ThinPrep Pap Test and an early adopter of ThinPrep technology in non-gynecological applications.

Quest Diagnostics is the nation's leading provider of diagnostic testing, information and services with $3.4 billion in annual revenues. The company's diagnostic testing yields information that enables health care professionals and consumers to make better decisions to improve health. Quest Diagnostics offers patients and physicians the broadest access to diagnostic testing services through its national network of approximately 30 full-service laboratories, 150 rapid response laboratories and more than 1,300 patient service centers, where specimens are collected. Quest Diagnostics is the leading provider of esoteric testing, including gene-based testing, and is the leader in routine medical testing, drugs of abuse testing, and anatomic pathology testing. Through partnerships with pharmaceutical, biotechnology and information technology companies, Quest Diagnostics provides support to help speed the development of health care insights and new therapeutics. Additional company information can be found on the Internet at: http://www.questdiagnostics.com.

InDuct is a registered trademark of ProDuct Health Incorporated.

ThinPrep is a registered trademark of Cytyc Corporation.

HercepTest is a trademark of Genentech, Inc. licensed to DAKO. SOURCE Quest Diagnostics Incorporated

CONTACT: Media - Gary Samuels, 201-393-5700, or Investors - Cathy Doherty, 201-393-5030, both for Quest Diagnostics Incorporated/

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