NORCROSS, Ga.–(BUSINESS
WIRE)–Guided Therapeutics, Inc. today announced that Health Canada has granted
marketing approval for the LuViva™ Advanced Cervical Scan.
The approval by Health Canada
provides LuViva access to the United
States largest trading partner and to other
markets that recognize Canadian device approval.
“Receiving Health Canada
marketing approval for LuViva is a significant milestone for the product and
the company,” said Mark L. Faupel, Ph.D., CEO and president of Guided
Therapeutics, Inc. “We are in discussions with potential distributors in Canada and
expect this approval to advance the process. Additionally, the Health Canada
approval helps to jumpstart and support the regulatory process in some Latin America and Southeast Asian countries.”
Each year, about 5.7 million women in Canada undergo Pap
test screening for cervical cancer, with as many as 400,000 receiving an
abnormal Pap result. These women are then scheduled for a follow-up exam,
called a colposcopy, which typically includes a biopsy. The wait times for
colposcopy examinations in Canada
are two to six months. LuViva is designed to reduce wait times and provide
results immediately at the point of care.
“We believe that LuViva has the potential to bring a new
level of efficiency to womens healthcare in Canada and improve the standard of
care by providing immediate results with a painless, one-minute test,” said Dr.
Faupel.
LuViva scans the cervix with light to identify cancer and
pre-cancer painlessly and non-invasively. Guided Therapeutics patented
biophotonic technology is able to distinguish between normal and diseased
tissue by detecting changes at the cellular level. Unlike Pap or human
papillomavirus (HPV) tests, LuViva does not require laboratory analysis or a
tissue sample.
The Health Canada application was filed under the former
name, “LightTouch” and will be amended to reflect the name change to LuViva.
About Guided Therapeutics
Guided Therapeutics, Inc. (OTCBB & OTCQB: GTHP) 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 same
technology platform. For more information, visit: www.guidedinc.com.
Posted by Sean Fenske, Editor-in-Chief, MDT
