08.19.14
Norcross, Ga.-based Guided Therapeutics Inc. will begin enrollment in a multi-center clinical trial to expand claims for the Luviva Advanced Cervical Scan to include front-line screening for cervical cancer.
The trial will be run by principal investigator, Daron G. Ferris, M.D., director, HPV (human papilloma virus) Prevention Program and professor of obstetrics and gynecology at the Medical College of Georgia at Georgia Regents University in Augusta. Ferris is the author of five peer-reviewed journal articles about Luviva and is the past-president of the American Society of Colposcopy and Cervical Pathology. The trial will take place at Georgia Regents University as well as CerviCusco, a Peruvian registered non-profit organization founded by Ferris, to address the exceedingly high rate of cervical cancer in rural Peru.
“Despite cervical cancer being the leading cause of cancer deaths in women in Peru, screening rates are less than 30 percent, even in advantaged urban areas of the country,” said Ferris. “As a result, Peru has one of the highest rates of cervical cancer in the world. We are excited to be conducting research with Guided Therapeutics to help prevent cervical cancer, by detecting premalignant changes of the cervix early when it can be treated effectively.”
“The lack of access to healthcare is a leading contributing factor to the large number of cases and the high death-rate from cervical cancer in developing countries,” said Gene Cartwright, CEO of Guided Therapeutics. “LuViva, which provides immediate results without the need for laboratory support, is an ideal technology to help fight cervical cancer with early detection. We are grateful for Dr. Ferris’ continued support for the technology and his vision for how it can save the lives of women around the world.”
The blinded trial is expected to enroll between 600 and 800 women, 160 women in Augusta and the remainder in Peru, and the results will be used to update and validate Luviva’s software for use as a primary screener for cervical disease that leads to cancer, much like the Pap test is used today. Luviva will be compared with visual examination with acetic acid, or VIA, with cytology, HPV, colposcopy and biopsy, where taken, as the gold standard. The trial is expected to take six to nine months.
The Luviva scan is currently approved for use in the European Union in a population of women identified as being at risk for cervical cancer by abnormal cytology (Pap), HPV test or previous cervical disease. The technology is under premarket approval review by the U.S. Food and Drug Administration.
The trial will be run by principal investigator, Daron G. Ferris, M.D., director, HPV (human papilloma virus) Prevention Program and professor of obstetrics and gynecology at the Medical College of Georgia at Georgia Regents University in Augusta. Ferris is the author of five peer-reviewed journal articles about Luviva and is the past-president of the American Society of Colposcopy and Cervical Pathology. The trial will take place at Georgia Regents University as well as CerviCusco, a Peruvian registered non-profit organization founded by Ferris, to address the exceedingly high rate of cervical cancer in rural Peru.
“Despite cervical cancer being the leading cause of cancer deaths in women in Peru, screening rates are less than 30 percent, even in advantaged urban areas of the country,” said Ferris. “As a result, Peru has one of the highest rates of cervical cancer in the world. We are excited to be conducting research with Guided Therapeutics to help prevent cervical cancer, by detecting premalignant changes of the cervix early when it can be treated effectively.”
“The lack of access to healthcare is a leading contributing factor to the large number of cases and the high death-rate from cervical cancer in developing countries,” said Gene Cartwright, CEO of Guided Therapeutics. “LuViva, which provides immediate results without the need for laboratory support, is an ideal technology to help fight cervical cancer with early detection. We are grateful for Dr. Ferris’ continued support for the technology and his vision for how it can save the lives of women around the world.”
The blinded trial is expected to enroll between 600 and 800 women, 160 women in Augusta and the remainder in Peru, and the results will be used to update and validate Luviva’s software for use as a primary screener for cervical disease that leads to cancer, much like the Pap test is used today. Luviva will be compared with visual examination with acetic acid, or VIA, with cytology, HPV, colposcopy and biopsy, where taken, as the gold standard. The trial is expected to take six to nine months.
The Luviva scan is currently approved for use in the European Union in a population of women identified as being at risk for cervical cancer by abnormal cytology (Pap), HPV test or previous cervical disease. The technology is under premarket approval review by the U.S. Food and Drug Administration.