Advanced Cervical Scan, under
development by Guided Therapeutics,
is designed as a new non-invasive test that has the potential to
significantly improve the early detection of cervical precancers. LuViva
is designed as a fast,
painless test that - unlike Pap smears and HPV testing -
does not require a tissue sample or the delay of laboratory
analysis. Early detection of cancer and precancers greatly
improves survival, and
LuViva is designed to
help preserve the reproductive health of women.
uses proprietary technology to identify cancers and precancers quickly by
analyzing light reflected from the cervix. The technology distinguishes between normal
and diseased tissue by detecting biochemical and morphological
changes at the cellular level.
More than 1,600 women at risk for
cervical disease were tested with the LuViva in a multi-center
pivotal clinical trial. Results of the trial showed that:
LuViva detected cervical
disease up to two years earlier than Pap test, HPV test,
colposcopy and biopsy.
LuViva detected 86.3%
cervical disease cases that had been missed by Pap, HPV
(human papillomavirus) tests and biopsy.
LuViva would have reduced the
number of unnecessary biopsies by about 40 percent.
Additionally, Guided Therapeutics’
clinical trial indicated that women aged 16-20 were just as
likely to have cervical disease as women 21 and older and
current methods of early detection, such as HPV testing, are not
recommended for this age group. LuViva detected cervical disease
equally well in both adolescent and adult women.
According to published reports, cervical cancer is the third
most common cancer among women worldwide. Globally, there are
approximately 471,000 cases of cervical cancer diagnosed
annually and approximately 233,000 deaths per year.
Approximately 60 million Pap tests are performed annually in the
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|CAUTION - Investigational
device. Limited by federal law to investigational use. The availability
of any product in the U.S. developed from these technologies is
dependent on FDA marketing approval. Global market availability is
dependent on additional regulatory approvals.