Poster Presentation made at annual ACOG meeting
NORCROSS, Ga.--(BUSINESS WIRE)--May 8, 2012-- Point-of-care testing with the LuViva(R) Advance Cervical Scan developed by Guided Therapeutics, Inc., (OTCBB: GTHP) (OTCQB: GTHP) combined with human papillomavirus (HPV) testing, could optimize early detection of cervical cancer and reduce by approximately one-third the number of unnecessary biopsies that result from the false positive rate of Pap tests, according to an analysis presented at the American Congress of Obstetricians and Gynecologists 60th Annual Clinical Meeting in San Diego.
Combining the two tests created a sensitivity of 99% and a negative predictive value (NPV) of 99%, according to the poster presentation entitled "Optimal combination of cervical spectroscopy with cytology and HPV: Implications for clinic efficiency." HPV testing alone generated a sensitivity of 81%. Sensitivity is the ability to correctly identify moderate and high-grade dysplasia; negative predictive value is the percentage of subjects with a negative test result who are correctly diagnosed. The poster was authored by Dr.
Marc L Winter of the Orange Coast Women's Medical Group and Dr. Daniel Sternfeld of the Saddleback Women's Medical Group, both of Laguna Hills, California.
"The implications of the study are fewer women undergoing painful and unnecessary biopsies, lower costs to the healthcare system, better care for women with disease and a more efficient practice for the physician," said Dr. Winter.
"LuViva would also be the first women's cancer detection tool that gives an immediate result, which could mean either instant relief, if negative, or the immediate initiation of treatment, if necessary," said Dr. Sternfeld. "We believe this will strengthen the doctor-patient relationship and ultimately lead to a reduction in cervical disease." Data were analyzed from a prospective Phase III study that enrolled 1,607 women referred to colposcopy and biopsy at seven U.S. centers, including 804 women that returned for follow up. On the day of study, each woman underwent a LuViva scan, had a specimen taken for cytology, an HPV test and colposcopy. Biopsy specimens were reviewed by a panel of histopathologists to determine a final diagnosis by which LuViva and the other tests were compared.
According to the presentation, "The combination of (LuViva) with HPV testing shows strong potential for reducing the overtreatment of false positives by providing an almost perfect sensitivity and negative predictive value for detection of CIN2+. Use of (LuViva) within a patient management algorithm that includes HPV testing would increase the yield of CIN2+ in the population of women referred to colposcopy and biopsy." About LuViva (R) 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(R) Cervical Guide single-use patient interface and calibration disposable.
About Guided Therapeutics Guided Therapeutics, Inc. (OTCBB: GTHP) (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 Company's first planned product is the LuViva(R) 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 Barrett's Esophagus using the technology platform. For more information, visit: www.guidedinc.com.
The Guided Therapeutics LuViva (R) Advanced Cervical Scan is an investigational device and is limited by federal law to investigational use. LuViva, the wave logo and "Early detection, better outcomes" are registered trademarks owned by Guided Therapeutics, Inc.
Forward-Looking Statements Disclaimer: A number of the matters and subject areas discussed in this news release that are not historical or current facts deal with potential future circumstances and developments. The discussion of such matters and subject areas is qualified by the inherent risks and uncertainties surrounding future expectations generally and also may materially differ from Guided Therapeutics' actual future experience involving any of or more of such matters and subject areas. Such risks and uncertainties include: the early stage of products in development, the uncertainty of market acceptance of products, the uncertainty of development or effectiveness of distribution channels, the intense competition in the medical device industry, the uncertainty of capital to develop products, the uncertainty of regulatory approval of products, dependence on licensed intellectual property, as well as those that are more fully described from time to time under the heading "Risk Factors" in Guided Therapeutics' reports filed with the SEC, including Guided Therapeutics' Annual Report on Form 10-K for the fiscal year ended December 31, 2011, and subsequent quarterly reports.
CONTACT: Cameron Associates Investor Relations: Alison Ziegler, 212-554-5469 or Guided Therapeutics Bill Wells, 770-242-8723, ext. 241 KEYWORD: UNITED STATES NORTH AMERICA CALIFORNIA GEORGIA INDUSTRY KEYWORD: HEALTH BIOTECHNOLOGY MEDICAL DEVICES ONCOLOGY SOURCE: Guided Therapeutics, Inc.
Copyright Business Wire 2012 PUB: 05/08/2012 08:05 AM/DISC: 05/08/2012 08:05 AM http://www.businesswire.com/news/home/20120508005967/