QUEST DIAGNOSTICS ADDS DIGENE
HYBRID CAPTURE(R) II HPV TEST TO ARRAY OF CERVICAL CANCER SCREENING SOLUTIONS
TETERBORO, N.J., JANUARY 14, 2000 Quest Diagnostics
Incorporated (NYSE: DGX), the nation's leading provider of diagnostic testing, information
and services, announced it has begun offering the Digene Hybrid Capture(R) II HPV (human
papillomavirus) test. HPV is a group of viruses, of which more than a dozen different
types have been linked to cervical cancer. Quest Diagnostics uses Hybrid Capture II
testing, the most advanced technology available for HPV testing, which enables a 10-fold
improvement in clinical sensitivity for detection of high-risk HPV over the previous
generation assay.
The HPV test, manufactured by Digene Corporation of Gaithersburg, Md., has been
approved by the U.S. Food and Drug Administration (FDA) for secondary, or confirmatory
cervical cancer testing. It is used as an adjunct to the ThinPrep(R) Pap Test(TM) or a
conventional Pap smear for cervical cancer screening and is not approved for primary
screening or for self-collection. Quest Diagnostics is now performing HC II HPV testing
and first began offering HPV testing in 1989.
While recent media reports have suggested that women may collect their own HPV
specimens without visiting their physician, the concept of self-collection is only being
discussed as a way to bring testing to women in parts of the world where access to
healthcare services is severely limited. To obtain HPV testing, a woman must first visit
her gynecologist or primary care physician. Additional information about HPV, including
the ASCUS/LSIL Triage Study (ALTS), which is investigating the best way to manage mild
cervical abnormalities, is available from the National Cancer Institute (NCI), which may
be contacted at 1-800-4-CANCER or on the Internet at: http://www.nci.nih.gov.
Quest Diagnostics offers women and their physicians a full range of cervical screening
options, including the ThinPrep Pap Test, conventional Pap smears and HPV testing. Quest
Diagnostics performs Pap tests using only cytotechnologists and board-certified
pathologists, who are medical doctors. The conventional Pap smear and the ThinPrep Pap
Test are approved by the FDA for primary screening.
"January is Cervical Cancer Month, and Quest Diagnostics is proud to offer the
most extensive menu of cervical cancer testing to physicians and their patients as part of
our recently launched Women's Health Initiative," said Surya N. Mohapatra, Ph.D.,
president and chief operating officer of Quest Diagnostics. "As the leading provider
of cervical cancer screening, we believe HPV testing may improve diagnostic information
for high-risk patients and their physicians, potentially leading to improved and more cost
effective treatment options. We will continue to monitor the ALTS study and to evaluate
new developments in cervical cancer screening. Quest Diagnostics strives to make new,
high-quality products and services available to our customers and patients."
Quest Diagnostics is the nation's leading provider of diagnostic testing, information
and services to physicians, hospitals, managed care organizations, employers and
government agencies with annualized revenues of more than $3 billion. The wide variety of
tests it performs 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, and manufactures and
distributes diagnostic test kits and instruments. Quest Diagnostics is one of the leading
providers of testing to support clinical trials of new pharmaceuticals worldwide. Quest
Informatics collects and analyzes laboratory, pharmaceutical and other data to help large
health care customers better manage the health of their patients. QuestNet is an
innovative new product offering that provides network management services to large buyers
of health care services. Additional company information can be found on the Internet at: http://www.questdiagnostics.com.
ThinPrep is a registered trademark and ThinPrep Pap Test is a trademark of Cytyc
Corporation. Hybrid Capture is a registered trademark of Digene Corporation.
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