MADISON, Wis. — Third Wave Technologies
Inc. ( Nasdaq: TWTI) today announced that the clinical trial for its two
human papillomavirus, or HPV, products is underway. Third Wave continues
to anticipate submitting the applications for approval of those products
to the U.S. Food and Drug Administration (FDA) in 2007.
Clinical trial site initiations and the enrollment of women for the
trial began in late July, after Third Wave worked closely with the FDA
on the clinical trial design. More than 20 sites have been qualified to
date.
“We are pleased to be a clinical trial site for Third Wave’s HPV
products,” said Arthur S. Waldbaum, M.D., president of Downtown Women’s
Health Care in Denver, and a principal investigator for the study. “The
clinical trial design we are using is well constructed and
straightforward, fitting very nicely within our normal procedures for
screening women for cervical cancer.”
“It is exciting to be involved in a study that will help to bring an
alternative to the current HPV testing options,” said Tyrone Malloy,
M.D., chief executive and medical director of Soapstone Center for
Clinical Research in Decatur, Ga., another principal investigator for
the study. “The ability to genotype HPV types 16 and 18 will generate
interest in light of the recent FDA approval of the vaccines.”
Third Wave announced in July that it will submit applications to the FDA
for the approval of two HPV products: a screening test to detect the
presence of 14 high-risk types of HPV and a genotyping test to detect
two specific types of HPV-16 and 18. These two HPV types cause
approximately 70% of the cases of cervical cancer.
The global market for HPV testing is approximately $150 million and
growing at more than 30% a year. Third Wave also announced recently that
in 2007 it will extend its women’s health product menu-and market
opportunity-to chlamydia and gonorrhea. The global market for chlamydia
and gonorrhea testing is more than $ 200 million and when combined with
HPV testing, represents approximately 20% of the global molecular
diagnostic market.
“Third Wave’s HPV products remain the company’s top priority and we are
excited to announce our next step forward in bringing FDA-approved
products to this large and growing market,” said Kevin T. Conroy,
president and chief executive of Third Wave. “Because Third Wave’s study
design is within the current standard of care for HPV testing and
cervical disease management, we are confident in our ability to complete
the clinical trial on time and on budget. We believe our HPV products
can create significant value for both our customers and shareholders.”
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 the company’s website at
http://www.twt.com.
