Published:
Guided Therapeutics Non-Invasive Cervical Cancer Detection Device Trial Confirms Current Tests Miss Disease; Create High False Positive Rates
BOSTON - (BUSINESS WIRE) - Results of the FDA pivotal clinical trial for the LightTouch
Non-invasive Cervical Cancer Detection Device conducted by Guided
Therapeutics, Inc. (GT) (Pink Sheets: GTHP), indicated that the
current system for diagnosing cervical disease missed the same amount of
disease as a landmark study carried out by the National
Cancer Institute (NCI).
In the new LightTouch study, conducted at six US clinics and with an
enrollment of approximately 2,000 women, 32% of cervical precancers and
cancers were missed by the current method of human papillomavirus (HPV)
testing and colposcopy, while only 19% of biopsy samples indicated the
presence of these diseases. Similarly, the
ASCUS/LSIL Triage Study for Cervical Cancer (ALTS), sponsored by
NCI, indicated that approximately 35% of disease was missed and only
about 26% of biopsies found significant disease. Both ALTS and the
LightTouch study used follow up data to estimate the number of missed
disease cases when the original diagnosis was rendered.
"ALTS sheds new light on problems plaguing cervical disease management
after a women undergoes Pap screening and adjunctive tests, such as HPV
and colposcopy," said Mark L. Faupel, Ph.D., President and CEO of GT.
"Our FDA study confirms the ALTS results and shows the high rate of
false positives and false negatives using conventional procedures and
technology."
The results were presented at NCI's inaugural Investor Forum at Boston
University. GT was selected as one of NCI's top innovators. GT has been
awarded approximately $6 million in six consecutive grants from the NCI
to develop the new, pain-free test for detecting cervical disease.
The GT LightTouch technology systematically and rapidly scans the cervix
to identify cancer and pre-cancer painlessly and non-invasively, by
analyzing the wavelengths of light reflected from cervical tissue. The
technology distinguishes between normal and diseased tissue by detecting
biochemical and morphological changes at the cellular level. Unlike Pap
or HPV tests, the LightTouch test does not require a tissue sample or
laboratory analysis, and is designed to provide results immediately. The
technology is designed as a device employing a single-use disposable
patient interface.
Organized and funded by the National Cancer Institute, ALTS included
more than 5,000 women. It began in November 1996 and concluded at the
end of 2000. ALTS was a clinical trial to find the best way to help
women and their doctors decide what to do about the mildly abnormal and
very common Pap test results known as ASCUS and LSIL. About three
million women in the United States are diagnosed with ASCUS and LSIL
each year.
Since development of the LightTouch began, more than 3,000 women have
been tested with the LightTouch, including approximately 2,000 women who
were enrolled in GT's FDA pivotal clinical trial.
According to studies published in the peer-reviewed Journal of Lower
Genital Tract Disease, the non-invasive LightTouch test has the
potential to be significantly more accurate when compared to tissue
sample-based tests such as Pap and HPV.
About Guided Therapeutics
Guided Therapeutics, Inc. (Pink
Sheets: GTHP) is developing a rapid and painless test for the early
detection of disease that leads to cervical cancer. The technology is
designed to provide an objective result at the point of care, thereby
improving the management of cervical disease. Unlike Pap and HPV tests,
the device does not require a painful tissue sample and results are
known immediately. GT also has an agreement with Konica
Minolta Opto, Inc. (KMOT) of Tokyo to co-develop non-invasive
products, for the detection of lung and esophageal cancer based on the
company's LightTouch non-invasive cervical cancer detection technology.
For more information, visit GT's web site www.guidedinc.com.
The Guided Therapeutics LightTouch Non-invasive Cervical Cancer
Detection Device is an investigational device and is limited by federal
law to investigational use.
"Safe Harbor" Statement under the Private Securities Litigation Reform
Act of 1995. A number of the matters and subject areas discussed in this
news release that are not historical or current facts deal with
potential future circumstances and developments. The discussion of such
matters and subject areas is qualified by the inherent risks and
uncertainties surrounding future expectations generally and also may
materially differ from Guided Therapeutics' actual future experience
involving any of or more of such matters and subject areas. Such risks
and uncertainties include: the early stage of products in development,
the uncertainty of market acceptance of products, the uncertainty of
development or effectiveness of distribution channels, the intense
competition in the medical device industry, the uncertainty of capital
to develop products, the uncertainty of regulatory approval of products,
dependence on licensed intellectual property, as well as those that are
more fully described from time to time under the heading "Risk Factors"
in Guided Therapeutics' reports filed with the SEC, including Guided
Therapeutics' Annual Report on Form 10-KA for the fiscal year ended
December 31, 2008 and subsequent quarterly reports.
Guided Therapeutics, Inc.
Bill Wells, 770-242-8723
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