Third Wave Technologies Inc. (NASDAQ: TWTI)
today announced that the company has received clearance from the U.S.
Food and Drug Administration of its InPlex™ CF
Molecular Test. The test simultaneously detects and identifies cystic
fibrosis mutations in patient DNA samples. The InPlex™
CF Molecular Test delivers the accuracy of Third Wave’s
Invader® chemistry in
an easy-to-use microfluidic card developed in collaboration with 3M Co.
In studies submitted to the FDA as part of the company’s
clearance application, the InPlex™ CF
Molecular Test achieved 100% agreement on cystic-fibrosis positive
samples and 99.96% overall agreement when compared to DNA sequencing,
the standard for genotype determination.1
The InPlex™ CF Molecular Test is a genotyping
test that provides information for cystic fibrosis carrier screening for
adults of reproductive age as recommended by the American College of
Medical Genetics (ACMG) and the 2005 American College of Obstetrics and
Gynecology (ACOG)2, as an aid in newborn
screening for cystic fibrosis, and in confirmatory diagnostic testing
for cystic fibrosis in newborns and children. The Third Wave InPlex™
CF Molecular Test panel includes mutations and variants recommended by
the 2004 ACMG.3 "Upon evaluation in our academic-hospital
clinical laboratory, we found the InPlex™ CF
card was sensitive and specific, and required minimal hands-on time and
training,” said Dr. Monique Johnson, research
assistant professor in the Department of Molecular and Medical Genetics
at Oregon Health and Science University. "With
minimal start-to-finish time, the InPlex™ CF
card generated easily-decipherable data and was overall an excellent CF
testing platform.” Dr. Johnson is the lead
author of "A Comparative Study of Five
Technologically Diverse CFTR Testing Platforms,”
which was published in the Journal of Molecular Diagnostics in July 2007.
"Customers consistently tell us that InPlex™
CF is the easiest method on the market,” said
Kevin T. Conroy, president and chief executive of Third Wave. "More
than 70 labs are employing our InPlex™
analyte specific reagents, making InPlex™ the
most reported method in use today. We believe the clearance of the InPlex™
CF Molecular Test will enable Third Wave to expand our 15% cystic
fibrosis market share and further establish our leadership in the
$270-million genetic and pharmacogenetic testing market.
"The FDA clearance of our InPlex™
CF Molecular Test marks the second successful submission by the
talented, innovative team at Third Wave and affirms the company’s
commitment to seeking FDA clearance for its clinical diagnostic products,”
Mr. Conroy said.
About Cystic Fibrosis
Cystic fibrosis is a fatal genetic disease that affects more than 30,000
Americans. It is the most common inherited disease in North America,
with one in 31 Americans carrying a cystic fibrosis mutation.4
Testing for cystic fibrosis provides critical information about parents’
carrier status. It also aids in the early diagnosis of newborns with
cystic fibrosis, which greatly improves the medical treatment and
options for those patients.
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 http://www.inplexcf.com
or company's website at www.twt.com.
1InPlex™ CF
Molecular Test Package Insert.
2Mennuti M. "Lights!
Camera! Action!” Obstetrics and Gynecology
Vol. 97, No 4:539-541 (2001).
3Watson M.S. et.al. "Cystic
fibrosis population carrier screening: 2004 revision of American College
of Medical Genetics mutation panel.” Genet.
Med. 6:387-91 (2004).
4Cystic Fibrosis Foundation website accessed
March 11, 2008.
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.
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