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New Painless Test for Cervical Cancer Outperforms Tissue Sample Tests

Posted on: Wednesday, 25 April 2007, 09:23 CDT

A new non-invasive test for cervical cancer, being developed by SpectRx, Inc. (OTCBB: SPRXE), is more effective at correctly identifying cervical disease from normal tissue than Pap and Human Papilloma Virus (HPV) combination testing, according to results of a study published in a peer-reviewed medical journal.

The new technology, which uses light to scan the cervix for disease, was tested on 102 women with abnormal Pap tests scheduled for colposcopy and biopsy at the University of Texas Southwestern Medical Center in Dallas. The study compared the results of a Pap test combined with the SpectRx non-invasive test against the results of a Pap test combined with HPV test. The sensitivity (the ability to accurately detect cancer) of both tests was 95%. The specificity (the ability to accurately detect benign or healthy tissue) of the Pap/SpectRx test was 65.5% versus 27.4% for the Pap/HPV test.

"We are very encouraged by the results of this study, and believe that it highlights the potential of the technology to improve the standard of care for women who may have cervical disease," said Mark Faupel, Ph.D., SpectRx president and chief operating officer. "Large studies, published this year in the Journal of the American Medical Association, show that the prevalence of HPV in the general population is higher than previously thought, indicating greater need for a new test to determine quickly and accurately those women who actually have disease versus those who do not."

Results of the study indicated the technology could potentially reduce the number of unnecessary follow up tests and biopsies by about two-thirds. The study was published in the April 2007 issue of the Journal of Lower Genital Tract Disease, the leading publication for the American Society for Colposcopy and Cervical Pathology.

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. In addition to the University of Texas, other clinical trial sites are 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.

The test 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. Worldwide, 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.

About SpectRx

SpectRx, Inc. (OTCBB: SPRXE) 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, 2005, as amended, and subsequent quarterly reports.

Source: Business Wire

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