The March 12, 2014, recommendation by a U.S. Food and Drug
Administration (FDA) panel to use human papillomavirus (HPV) testing as
an alternative to Pap testing for screening of women for cervical cancer
has the potential to increase the need for the LuViva® Advanced Cervical
Scan in developed countries, according to Guided Therapeutics, Inc.
(OTCBB: GTHP) (OTCQB: GTHP). As part of its CE Mark, LuViva is already
approved for use in the European Union as a triage test to be used after
a positive HPV test and/or a positive Pap test.
"Based on published studies, we would expect a gradual shift to HPV
screening to increase the number of initially positive results compared
to the Pap smear," said Gene Cartwright, Chief Executive Officer of
Guided Therapeutics. "A high percentage of these screening positives are
actually false positives. The LuViva technology has been proven to be
capable of determining which of the screened Pap smear positives are
false positives. We expect similar performance when the LuViva
technology is applied to HPV screening results."
"Because the number of positives and false positives has been proven to
be higher when HPV is used as a screening test, as reported in several
peer-reviewed journals including The Lancet, the need for a technology
like LuViva, that can determine which of the initially screened
positives are actually false positives should increase if HPV screening
LuViva as a potential screening solution in developing countries --
"Separately, in developing markets the need for lab infrastructure and
the expense of Pap and HPV tests often leads to countries screening only
low percentages of their female population for cervical cancer. The
Ministries of Health in Turkey and Nigeria view LuViva as a potential
solution for screening and are conducting clinical trials to use LuViva
as a primary screening device. Wth LuViva, there is no biopsy sample
taken and the result is available immediately which is an important
feature to prevent losing positively tested women to follow up," Mr.
About LuViva® Advanced Cervical Scan
LuViva is a technologically advanced diagnostic device that scans the
cervix with light and uses spectroscopy to measure how light interacts
with the cervical tissue. Spectroscopy identifies chemical and
structural indicators of precancer that may be below the surface of the
cervix or misdiagnosed as benign. This technique is called biophotonics.
Unlike Pap, HPV tests or biopsies, LuViva does not require laboratory
analysis or a tissue sample, and is designed to provide results
immediately, which eliminates costly, painful and unnecessary testing.
LuViva is designed for use with women who have undergone initial
screening and are called back for follow up with a colposcopy
examination, which in many cases, involves taking a biopsy of the
cervix. The device is used in conjunction with the LuViva®
Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB: GTHP) is the maker of a
rapid and painless testing platform based on its patented biophotonic
technology that utilizes light for the early detection of disease at the
cellular level. The Company's first product is the LuViva® Advanced
Cervical Scan, a non-invasive device used to detect cervical disease
instantly and at the point of care. In a multi-center clinical trial,
with women at risk for cervical disease, the technology was able to
detect cervical cancer up to two years earlier than conventional
modalities, according to published reports. Guided Therapeutics is also
developing a non-invasive test for the early detection of esophageal
cancer using the technology platform. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva® Advanced
Cervical Scan is an investigational device and is limited by federal law
to investigational use. LuViva, the wave logo and "Early detection,
better outcomes" are registered trademarks owned by Guided Therapeutics,
Forward-Looking Statements Disclaimer: 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 those related to 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-K for the fiscal year ended December 31, 2012,
and subsequent quarterly reports.
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