Third Wave's HPV Clinical Trial Achieves Primary Clinical Endpoints
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Third Wave Technologies Inc. (NASDAQ: TWTI) today announced that the
company achieved all primary clinical endpoints in the clinical trial
for its human papillomavirus (HPV) tests. The company expects to submit
the trial results to the U.S. Food and Drug Administration for both its
high-risk and 16/18 genotyping products in April.
Third Wave’s 14-type high-risk HPV test
demonstrated a negative predictive value greater than the study’s
99% goal. Negative predictive value is the probability that there is no
cervical disease in a patient with atypical or ASCUS Pap test results
and negative HPV test results.
The company’s proprietary high-risk HPV test
is intended to be used in combination with a Pap test to assess women 30
and over for the presence of high-risk HPV types and to guide their
treatment. It is also intended to test patients with abnormal Pap
results to determine whether they should be referred to colposcopy.
Third Wave believes that its high-risk HPV test demonstrated performance
in the clinical trial that met the key performance criteria established
by the ALTS clinical trial, the foundational HPV screening study
sponsored by the National Cancer Institute. The company also achieved
the primary clinical endpoints for its HPV genotyping test. This test
detects the presence of HPV types 16 and 18, the types that cause
approximately 70% of cervical disease.
Third Wave initiated its HPV clinical trial two years ago, in early
2006. The company screened more than 50,000 subjects and enrolled over
3,400 subjects from 47 sites, including more than 1,300 women with ASCUS
Pap test results. In April, Third Wave will make submissions based on
these data to the FDA for both its high-risk and 16/18 genotyping
products. The company expects to share publicly the clinical trial data
shortly after making those FDA submissions. Third Wave believes that an
HPV clinical trial is a highly complex undertaking with significant
risks both before and after submission to the FDA.
"We are very pleased with the robust performance demonstrated by both of
our HPV tests in the clinical trial," said Kevin T. Conroy, president
and chief executive of Third Wave. "Our
clinical trial results validate the company's significant investment in
our HPV program, an investment responsive to the many clinical
laboratories and thought leaders who have voiced the need for an
alternative to the current test on the market. The clinical utility of
HPV testing is well documented and we look for the market to continue to
grow and further penetrate clinical practice in the United States and
internationally. Third Wave’s participation in
this large, rapidly-growing market extends the company’s
position as a leader in clinical molecular diagnostics.” About the HPV Testing Market
The global market for HPV testing is projected to be $250 million in
2008 and the total available market is $1 billion. There are more than
10 million HPV tests being performed in the United States annually with
only 28% market penetration. The U.S. market is approximately $200
million annually and has grown in excess of 40% for each of the last
five years. The company expects market growth to continue in excess of
25% in the near term.
The HPV testing market in the EU is just emerging, as studies are
underway evaluating the use of HPV tests as a primary screen for
cervical cancer in women, replacing Pap testing.
About Third Wave Technologies
Third Wave develops and markets molecular diagnostic reagents for a
variety of DNA and RNA analysis applications to meet the needs of our
customers. The company offers a number of products based on its Invader®
chemistry for clinical testing. Third Wave offers in vitro diagnostic
kits, and analyte specific, general purpose, and research use only
reagents for nucleic acid analysis. For more information about Third
Wave and its products, please visit the company's website at www.twt.com.
All statements in this news release that are not historical are
forward-looking statements within the meaning of the Securities Exchange
Act of 1934 as amended. Such forward-looking statements are subject to
factors that could cause actual results to differ materially for Third
Wave from those projected. Those factors include risks and uncertainties
relating to the company's ability to bring new products to market as
anticipated, the current regulatory environment in which the company
sells its products, the market acceptance of those products, dependence
on partners and customers, successful performance under collaborative
and commercial agreements, competition, the strength of the Third Wave
intellectual property, the intellectual property of others and other
risk factors identified in the documents Third Wave has filed, or will
file, with the Securities and Exchange Commission. Copies of the Third
Wave filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov.
Third Wave expressly disclaims any obligation or undertaking to release
publicly any updates or revisions to any forward- looking statements
contained herein to reflect any change in Third Wave's expectations with
regard thereto or any change in events, conditions, or circumstances on
which any such statements are based. Third Wave Technologies, Invader
and the Third Wave logo are trademarks of Third Wave Technologies, Inc.