Press Release Details

Quest Diagnostics Announces Availability of HEPTIMAX Ultra-Sensitive Quantitative Hepatitis C Virus Test


The new offering, called the HEPTIMAX(TM) viral load test, is capable of detecting minute quantities of hepatitis C virus down to as few as 5 International Units (IUs) per milliliter (ml). The ability to detect minute quantities of virus is useful to physicians in monitoring the effectiveness of various treatments for hepatitis C in patients. The HEPTIMAX(TM) viral load test not only delivers the maximum sensitivity but also offers the maximum range (5 IUs/ml to 8.3 million IUs/ml).

This proprietary test is ordered by physicians to monitor and confirm hepatitis C viral infection and to demonstrate post-treatment resolution of the infection. Because the HEPTIMAX(TM) viral load test combines the new TMA technology with traditional quantitative viral load testing using branched DNA technology, it simplifies patient management by allowing physicians to order just one test to cover the complete range of possible viral load values from 5 IUs to 8.3 million IUs per ml.

"The improved sensitivity of the HEPTIMAX(TM) viral load test is particularly relevant to physicians with the advent of new forms of hepatitis C therapeutics," said Jorge Leon, Ph.D., Vice President for Applied Genomics at Quest Diagnostics. "New combination therapies utilizing sustained-action forms of interferon have shown better treatment responses in clinical trials that translate to lower levels of virus in patients."

"Preliminary studies comparing the HEPTIMAX(TM) viral load test to other technologies and laboratories confirm it has superior sensitivity," said Dr. Peter Heseltine, Medical Director of Infectious Diseases for Quest Diagnostics. "We are planning additional studies with other outside investigators to confirm and publish our findings."

A study published in the October 2000 issue of the journal "Hepatology" utilizing a hepatitis C qualitative version of the TMA test, showed it to be a better predictor of end-of-treatment resolution than the other methods.

The new test was developed by Quest Diagnostics at Nichols Institute and is offered exclusively through Quest Diagnostics' national laboratory network. The highly sensitive HEPTIMAX(TM) HCV assay utilizes reagents from Bayer Diagnostics, based on proprietary TMA technology made available through Bayer's exclusive agreement with Gen-Probe, San Diego, CA.

The HEPTIMAX(TM) viral load test is the latest addition to Quest Diagnostics' comprehensive test menu for hepatitis C disease management. Quest Diagnostics provides a complete selection of tests for initial diagnosis, treatment monitoring and managing HCV infected patients. The menu also features the DupliType(TM) HCV genotype test, which helps physicians establish the appropriate duration of HCV therapy. Quest Diagnostics introduced the HCV DupliType(TM) test to provide subtyping for a broader range of hepatitis C viral isolates than was previously available using other technologies.

An estimated 4 million people are infected with hepatitis C virus in the United States, and approximately 130,000 patients currently receive treatment. Physicians monitor viral loads in infected patients to test the effectiveness of various types of combination therapies.

Quest Diagnostics' gene-based testing focuses on infectious disease, oncology and heritable conditions, and helps physicians target individual treatment regimes, monitor resistance to therapies and predict predisposition to various genetic conditions. Quest Diagnostics is a leading innovator in genomics testing, through its research and development center and esoteric testing laboratory, the world-renowned Nichols Institute, as well as through alliances with leading academic and commercial technology developers.

About Quest Diagnostics

Quest Diagnostics is the nation's leading provider of diagnostic testing, information and services with annual revenues of $3.4 billion in 2000. 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 non-hospital-based 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:

The statements in this press release which are not historical facts or information may be forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause the outcome to be materially different. Certain of these risks and uncertainties are described in the Quest Diagnostics Incorporated 2000 Form 10-K and subsequent filings.

The HEPTIMAX viral load test and DupliType HCV genotype test are trademarks of Quest Diagnostics Incorporated.

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