TUCSON, Ariz., Sept. 4 /PRNewswire/ -- Ventana Medical Systems, Inc.
(Nasdaq: VMSI), a leading supplier of automated instrument reagent systems to
histology and drug discovery labs worldwide, today announced that the clinical
utility of the company's INFORM(R) Human Papillomavirus (HPV) ASR High Risk
and Low Risk Probes has been supported by two additional studies that
correlated Pap smear results with histology, clinical follow-up and HPV
detection. Both studies were presented at the 19th International
Papillomavirus Conference in Florianopolis, Brazil, on September 1, 2001.
"We are very excited with the results of these additional studies
comparing the INFORM(R) HPV ASR High Risk and Low Risk probes with other
available methods," said Christopher Gleeson, Ventana's president and chief
executive officer. "The studies support our belief that providing a doctor
with a visual picture of the infected cells is important in determining which
women who test positive for HPV will progress to disease. By reducing false
positives, women who do not have disease can avoid the anxiety that
accompanies testing positive for a sexually transmitted, cancer-causing virus,
eliminate costly follow-up analysis, and avoid unnecessary invasive procedures
including surgery."
The INFORM(R) HPV ASR probes are the first automated in situ hybridization
(ISH), or slide-based, applications for HPV DNA detection and allow physicians
to see the cells in their cellular context on a slide. Visualization of the
cells and the surrounding tissues gives physicians important clues to help
determine which patients are at greater risk of developing cervical cancer.
HPV is one of the most common sexually transmitted diseases in the United
States and the primary cause of cervical cancer. Approximately 110 million
Pap tests are performed annually worldwide and only a small percentage of HPV-
positive cases actually progress to cancer. Traditional test-tube methods
detect the presence of the HPV virus regardless of any effect on the patient.
Because of this, the traditional methods could give a positive test result,
even though the Pap test may be normal.
Supporting clinical data presented by Dr. David Baunoch, vice president of
operations at US Labs, a national anatomic pathology laboratory based in
California, focused on the use of molecular methods-rather than routine Pap
testing and colposcopy that are the norm-for the follow-up of abnormal Pap
smear results known as ASCUS.
Dr. Baunoch stated, "Recent studies have suggested that molecular tests
for HPV High Risk types can be used to identify patients who are at risk of
malignant progression. Preliminary results suggest that Ventana's INFORM(R)
HPV ASR allows for the identification of HPV positive cells in their
morphologic context." He also noted that ISH allows the direct correlation of
the virus to the original Pap test, which is important in eliminating false
positives.
A second study was presented by Dr. Elizabeth Euscher from a data abstract
co-authored by internationally renowned HPV expert Dr. Gerard Nuovo and Dr.
Geetha Menezes, Dr. Franceso Catania and Dr. Jeffery Chancellor. All are with
Ohio State University Medical Center, Columbus, Ohio. The goal of this study
was to correlate cervical cytology with HPV detection and clinical outcome.
Dr. Euscher stated, "The results of this study support the clinical utility of
testing for HPV by ISH in predicting which women with ASCUS are at high risk
and, as importantly, low risk for SIL (Unequivocal Squamous Intraepithelial
Lesion)."
"The study reveals the strong positive predictive value of our slide-based
molecular method and thus the important role these methods will play in HPV
testing," explained Dr. Thomas Grogan, M.D., Ventana chief scientific officer.
"We are conducting further studies designed to support pathologists and
clinicians in providing information that leads to improved patient care. This
is completely in line with our goal of building the Ventana franchise in the
women's health market worldwide by providing unique diagnostic tests that will
assist in improving the practice of medicine and the overall quality of
patient care," added Gleeson.
The INFORM(R) HPV ASR is a recent addition to the menu available for the
fully automated BenchMark(TM) system. Other menu items include a HER-2/neu
gene test used in conjunction with the company's recently FDA-approved PATHWAY
test for the HER2/neu protein.
This news release contains certain "forward-looking" statements and
information within the meaning of Section 27A of the Securities Act of 1933
and Section 21E of the Securities Exchange Act of 1934. Forward-looking
statements, by their very nature, include risks and uncertainties.
Accordingly, the company's actual results could differ materially from those
discussed in this release. A wide variety of factors could cause or
contribute to such differences and could adversely impact revenues,
profitability, cash flows and capital needs. Such factors, many of which are
beyond the control of the company, include the following: market acceptance of
new automated histology products, continued success in asset management,
continued improvements in our manufacturing efficiencies, on-schedule launches
of our new products, currency exchange rate variability, competition and
competitive pressures on pricing and general economic conditions in the United
States and in the regions served by the company. A more complete listing of
cautionary statements and risk factors is contained in the company's report on
Form 10-K for the year ended Dec. 31, 2000, filed with the Securities and
Exchange Commission.
Ventana develops, manufactures and markets instrument/reagent systems that
automate tissue preparation and slide staining in clinical histology and drug
discovery laboratories worldwide. Ventana's clinical systems are important
tools used in the diagnosis and treatment of cancer and infectious diseases.
Ventana's drug discovery systems are used to accelerate the discovery of new
drug targets and evaluate the safety of new drug compounds.
Visit the Ventana Medical Systems, Inc. website at http://www.ventanamed.com .
The Molecular Discovery Systems Division has its own website at
http://www.ventanadiscovery.com .
SOURCE Ventana Medical Systems, Inc.
 back to top
Related links:
http://www.ventanamed.com
CONTACT:
Christopher Gleeson, President and CEO of
Ventana Medical Systems, Inc., +1-520-690-3557; or Analyst
Contact, Kathy Brunson of The Financial Relations Board BSMG
Worldwide, +1-312-640-6696
|
