Third Wave's InPlex(TM) CF Molecular Test Receives FDA Clearance

Fri Mar 14, 2008 4:05pm EDT

* Reuters is not responsible for the content in this press release.

Marks second successful FDA submission by the company
MADISON, Wis.--(Business Wire)--
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(TM) CF Molecular Test. The test
simultaneously detects and identifies cystic fibrosis mutations in
patient DNA samples. The InPlex(TM) CF Molecular Test delivers the
accuracy of Third Wave's Invader(R) 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(TM) 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

   The InPlex(TM) 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(TM) 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(TM) 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(TM) 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(TM) 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(TM) analyte specific reagents, making InPlex(TM) the most
reported method in use today. We believe the clearance of the
InPlex(TM) 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(TM) 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(R) 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 or company's website at

   (1)InPlex(TM) CF Molecular Test Package Insert.

   (2)Mennuti M. "Lights! Camera! Action!" Obstetrics and Gynecology
Vol. 97, No 4:539-541 (2001).

   (3)Watson M.S. "Cystic fibrosis population carrier
screening: 2004 revision of American College of Medical Genetics
mutation panel." Genet. Med. 6:387-91 (2004).

   (4)Cystic 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
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.

The Luminis Group, Ltd.
for Third Wave Technologies Inc.
Rod Hise
+1 (608) 807-4607

Copyright Business Wire 2008
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