Healthcare Industry News: colposcopy
News Release - January 10, 2007
Painless Cancer Test May Eliminate Half of Unnecessary Cervical BiopsiesSpectRx Non-Invasive Cervical Cancer Detection Device in FDA Pivotal Clinical Trials
NORCROSS, Ga.--(HSMN NewsFeed)--A non-invasive device being developed by SpectRx, Inc. (OTCBB: SPRX ) to detect cervical cancer and precancer could reduce unnecessary biopsies by 55% while accurately detecting disease, according to results of a study published in the January edition of the Journal of Lower Genital Tract Disease. The device, in FDA pivotal clinical trials at five sites, is simple to use and was "well accepted" by subjects, according to the study.
"Recent advances in cervical cancer treatment and prevention are drawing more attention to the need for a more effective and humane method of detecting cervical disease that also helps to preserve the reproductive health of women," said Mark Faupel, Ph.D., SpectRx chief technical officer. "In addition to potentially reducing the pain and extra cost of following up on false-positive results, the study reported that our device was simple to use and was well accepted by test subjects."
"This product is a key part of our strategy to apply the company's extensive non-invasive diagnostic capability to the growing cancer diagnostic market," said Mark A. Samuels, SpectRx Chairman and CEO. "With the completion of the FDA pivotal study expected later this year and a large potential market, the cervical cancer test is expected to be a key element in our efforts to build shareholder value over the next several years."
The study was completed on women aged 18 to 75 years at clinical sites including Emory University/Grady Memorial Hospital in Atlanta, the Medical College of Georgia in Augusta, GA, University of Miami and St. Francis Hospital/University of Connecticut in Hartford. The sensitivity and specificity of the SpectRx test was 95% and 55%, respectively, when compared to histopathology. The study was conducted on a population of women who were referred for biopsy or who had an atypical Pap test result.
The median age of the 629 study participants was 27.7 years; 354 (57.6%) were younger than 30 years at the time of the study. Three hundred forty-five characterized themselves as African American, 139 as Hispanic, 141 as white, and four as Asian American or other.
The Journal of Lower Genital Tract Disease is the official publication of the American Society for colposcopy and Cervical Pathology and a number of international colposcopy and cervical pathology societies.
The non-invasive cervical cancer detection device, which is undergoing FDA pivotal clinical trials, uses proprietary technology to identify cancers and precancers painlessly and non-invasively 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. Unlike Pap or HPV tests, the non-invasive test does not require a tissue sample or laboratory analysis, and results are available immediately. To date, more than 2,000 women have been tested with prototypes of the non-invasive cervical cancer detection device. Research and commercialization of the device are being funded, in part, by grants from the National Cancer Institute (NCI). The non-invasive cervical cancer detection technology is being commercialized by SpectRx's subsidiary, Guided Therapeutics, Inc.
According to published reports, cervical cancer is the second most common cancer, after breast cancer, among women worldwide and the third most common overall. 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 United States.
SpectRx, Inc. (OTCBB: SPRX ) is a medical technology company providing innovative detection, monitoring and treatment solutions for the diabetes and cancer detection healthcare markets. SpectRx markets the SimpleChoiceŽ line of innovative diabetes management products, which include insulin pump disposable supplies. SpectRx also plans to develop a consumer device for continuous glucose monitoring. For more information, visit SpectRx's web sites at www.spectrx.com, www.mysimplechoice.com and www.guidedtherapeutics.com.
The SpectRx Non-invasive Cervical Cancer Detection Device is an investigational device and is limited by federal law to investigational use.
"Safe Harbor" Statement under the Private Securities Litigation Reform Act of 1995. 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 SpectRx's 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 SpectRx's reports filed with the SEC, including SpectRx's Annual Report on Form 10-KSB for the fiscal year ended December 31, 2005, as amended, and subsequent quarterly reports.
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.