NORCROSS, GA (July 18, 2012) – Guided Therapeutics, Inc. (OTCBB: GTHP) (OTCQB:
GTHP) today announced that it has received notification that CE Mark approval has been
granted for LuViva® Advanced Cervical Scan, a non-invasive device used to detect cervical
disease that leads to cancer, instantly and at the point of care.
The CE Mark is required to sell products in the 27 nations that comprise the European Union
(EU). There are about 146 million women who are targeted by existing or planned cervical cancer screening programs in EU member states, according the European Cancer Observatory.
"The notification of CE Mark for LuViva is a significant milestone for the company and allows
us to begin our European launch later this year, as planned," said Mark L. Faupel, Ph.D., president and CEO of Guided Therapeutics. “We believe that together with our distributors, we have a tremendous opportunity to improve the detection of cervical disease, reduce false
positives and unnecessary biopsies, and provide significant savings to healthcare systems
“Notification of the CE Mark and previously announced Health Canada approval for LuViva
further validates the product and our ability to manufacture to the highest standards. We expect the CE Mark award will generate more demand for the product and open opportunities in markets outside the EU as well. In addition to the more than 20 countries already covered by distribution agreements, we plan to expand our network to additional countries in Europe, Latin
America and Asia and having the CE Mark should accelerate those efforts,” Dr. Faupel added.
Today's CE Mark notification is the first of two expected for LuViva. A second CE Mark
application is expected to be filed later this year to comply with updated European medical
device standards and to include design improvements. The company also must continue to pass annual ISO audits of its quality system in order to maintain the CE Mark on its products. The company has passed two consecutive ISO audits, the last being in January of 2012.
In addition to the CE Mark, LuViva has marketing approval from Health Canada and remains under U.S. Food and Drug Administration premarket approval review. Guided Therapeutics was awarded ISO 13485 certification in January, 2011.
The study used to support LuViva’s CE Mark application was the multi-center U.S. pivotal trial, in which 1,607 women at risk for developing cervical disease were valuated. 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 is initially intended as a follow-up test after a positive Pap result.