NORCROSS, Ga.–(BUSINESS WIRE)–Guided Therapeutics,
Inc. today announced that it has submitted the
application for CE Mark approval for LuViva® Advanced Cervical Scan. The CE
Mark is required to market LuViva in the 27 nations that comprise the European
Union (EU).
“The filing of our CE Mark approval application for
LuViva is a significant milestone for the company and puts us on track, when
approved, for a full-scale European launch in the third quarter of this
year,” said Mark L. Faupel, Ph.D., president and CEO of Guided
Therapeutics. “We view the international market segment as significant
opportunity for LuViva because of the products versatility and ability to
adapt to the various diagnostic routines in different countries.”
Distribution agreements are currently in various stages of
completion for several EU and Asian countries, including Germany, the United Kingdom and several South
Asian countries. The company also has initial orders for clinical and
demonstrations units in hand for European and Asian countries.
LuViva received Health Canada marketing approval on
December 14, 2011. Guided Therapeutics received its ISO 13485 certification in
January 2011. LuViva remains under U.S. Food and Drug Administration premarket
approval review for which the company intends to request an independent panel
review of its application, as well as, explore other options with the agency.
According to the European Cancer Observatory, 146 million
women are targeted by cervical cancer screening programs which are currently
running or being established in the EU.
The study used to support LuVivas CE Mark application was
the multi-center U.S.
pivotal trial in which 1,607 women at risk for developing cervical disease were
diagnosed. In this patient population, LuViva was able to detect cervical
cancer up to two years earlier than the Pap test, human papillomavirus (HPV)
test, colposcopy and biopsy. LuViva detected 86.3 percent of the cervical
disease cases that had been missed by Pap, HPV tests and biopsy. LuViva would
have reduced the number of unnecessary biopsies by about 40 percent. LuViva
detected cervical disease equally in women ages 16 to 86 years and across a
broad spectrum of races.
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. is developing a rapid and painless testing platform
for the early detection of disease based on its patented biophotonic technology
that utilizes light to detect disease at the cellular level. The companys
first planned 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
has also entered into a partnership with Konica Minolta Opto to develop a
non-invasive test for Barretts Esophagus using the technology platform. For
more information, visit: www.guidedinc.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
