Healthcare Industry News: colposcopy
News Release - October 30, 2007
New Painless Test for Cervical Cancer Could Provide Access to Better Healthcare for Women WorldwideSpectRx test uses light to scan for disease and is designed to give results immediately
NORCROSS, Ga.--(HSMN NewsFeed)--A new non-invasive test that scans for cervical cancer, being developed by SpectRx, Inc. (Pink Sheets: SPRX ), may lead to earlier detection of cervical disease in women of developing countries that lack the infrastructure to perform Pap or human papilloma virus (HPV) testing.
According to the World Health Organization, cervical cancer is the second most common cancer in women and the most common in developing countries. About 200,000 women die from cervical cancer each year; 80 percent from developing countries.
“We believe, that by providing a point-of-care test that provides immediate results, there is a significant opportunity to improve the level healthcare of women in developing countries, as well as in countries with more advanced health systems,” said Mark Faupel, Ph.D., SpectRx, Inc. CEO and President. “A recent presentation and reviews by leading international women’s health physicians indicate a high level of interest in our scanning technology as a means to reduce global cervical cancer deaths.”
The SpectRx test improved detection of high-grade cervical precancer, eliminated unnecessary follow-up testing and was relatively simple to carry out, according to results of clinical studies of the technology, presented by Dr. Nahida Chakhtoura of the University of Miami at an international conference on cervical disease in Brazil earlier this year. Results of the study indicated that the SpectRx test was able to detect cases of cervical precancer that were missed by the Pap test and those missed by the center’s pathology department, but determined by external pathology review to be premalignant or malignant.
“I was very impressed with the device, as it could clearly detect abnormalities on the cervix which an ordinary colposcopy could not do,” wrote Dr. Gurujala Shailaja, Superintendent of the Government Maternity Hospital in Hyderabad, India, after observing the technology in a clinical study. “It will be useful as a screening procedure in India as we can avoid colposcopic directed biopsies. Due to the ease of use, the clarity and pickup of atypical areas, this device will be a huge success in the Indian market.”
The test uses proprietary technology to identify cancers and precancers painlessly and non-invasively by scanning the cervix with light. 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 scan does not require a tissue sample or laboratory analysis, and results are available immediately. To date, more than 2,500 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 more than $3 million in grants from the National Cancer Institute (NCI).
The SpectRx test is undergoing its pivotal clinical trial in anticipation of a premarket approval (PMA) application with the U.S. Food and Drug Administration. Clinical trial sites are the University of Texas; Emory University/Grady Memorial Hospital in Atlanta; the Medical College of Georgia in Augusta, GA; the University of Miami Miller School of Medicine; and, St. Francis Hospital/University of Connecticut in Hartford.
SpectRx, Inc. (Pink Sheets: SPRX ) is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to quickly eliminate false positive Pap and HPV results and discover cervical disease missed by existing tests. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately. For more information, visit SpectRx’s web sites at www.spectrx.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, 2006 and subsequent quarterly reports.
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