Guided Therapeutics Non-Invasive Cervical Cancer Detection Device Trial Confirms Current Tests Miss Disease; Create High False Positive Rates.Preview of FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Pivotal Clinical Trial Results Presented at National Cancer Institute Conference BOSTON -- Results of the FDA pivotal clinical trial for the LightTouch[TM] Non-invasive Cervical Cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. Detection Device conducted by Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP GTHP Generalized Tomlinson-Harashima Precoding ), indicated that the current system for diagnosing cervical disease missed the same amount of disease as a landmark study carried out by the National Cancer Institute (NCI See Liberate. ). In the new LightTouch study, conducted at six US clinics and with an enrollment of approximately 2,000 women, 32% of cervical precancers and cancers were missed by the current method of human papillomavirus human papillomavirus (HPV), any of a family of more than 60 viruses that cause various growths, including plantar warts and genital warts, a sexually transmitted disease. Detectable warts can be or removed, usually by chemicals, freezing, or laser, but often recur. (HPV HPV human papillomavirus. HPV abbr. human papilloma virus Human papilloma virus (HPV) ) testing and colposcopy Colposcopy Definition Colposcopy is a procedure that allows a physician to take a closer look at a woman's cervix and vagina using a special instrument called a colposcope. It is used to check for precancerous or abnormal areas. , while only 19% of biopsy samples indicated the presence of these diseases. Similarly, the ASCUS/LSIL Triage triage Division of patients for priority of care, usually into three categories: those who will not survive even with treatment; those who will survive without treatment; and those whose survival depends on treatment. Study for Cervical Cancer (ALTS ALTS Association for Local Telecommunications Services ALTS Aarhus Lawn Tennis Selskab (Denmark) ALTS Annotated Labeled Transition System ALTS Analogue Line Terminating Subsystem ALTS Automatic Laser Tracking System ), sponsored by NCI, indicated that approximately 35% of disease was missed and only about 26% of biopsies found significant disease. Both ALTS and the LightTouch study used follow up data to estimate the number of missed disease cases when the original diagnosis was rendered. "ALTS sheds new light on problems plaguing cervical disease management after a women undergoes Pap screening and adjunctive tests, such as HPV and colposcopy," said Mark L. Faupel, Ph.D., President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of GT. "Our FDA study confirms the ALTS results and shows the high rate of false positives and false negatives using conventional procedures and technology." The results were presented at NCI's inaugural Investor Forum at Boston University. GT was selected as one of NCI's top innovators. GT has been awarded approximately $6 million in six consecutive grants from the NCI to develop the new, pain-free test for detecting cervical disease. The GT LightTouch technology systematically and rapidly scans the cervix to identify cancer and pre-cancer painlessly and non-invasively, by analyzing the wavelengths of light reflected from cervical tissue. The technology distinguishes between normal and diseased tissue by detecting biochemical and morphological changes at the cellular level. Unlike Pap or HPV tests, the LightTouch test does not require a tissue sample or laboratory analysis, and is designed to provide results immediately. The technology is designed as a device employing a single-use disposable patient interface. Organized and funded by the National Cancer Institute, ALTS included more than 5,000 women. It began in November 1996 and concluded at the end of 2000. ALTS was a clinical trial to find the best way to help women and their doctors decide what to do about the mildly abnormal and very common Pap test Pap test, Pap smear, or Papanicolaou test (păp'ənē`kəlou), medical procedure used to detect cancer of the uterine cervix. results known as ASCUS as·cus n. pl. as·ci A membranous, often club-shaped structure in which typically eight spores are formed through sexual reproduction of ascomycetes. ascus pl. asci; the spore case of Ascomycetes. and LSIL LSIL Low-grade squamous intraepithelial lesion, see there . About three million women in the United States are diagnosed with ASCUS and LSIL each year. Since development of the LightTouch began, more than 3,000 women have been tested with the LightTouch, including approximately 2,000 women who were enrolled in GT's FDA pivotal clinical trial. According to studies published in the peer-reviewed Journal of Lower Genital Tract Disease, the non-invasive LightTouch test has the potential to be significantly more accurate when compared to tissue sample-based tests such as Pap and HPV. About Guided Therapeutics Guided Therapeutics, Inc. (Pink Sheets: GTHP) is developing a rapid and painless test for the early detection of disease that leads to cervical cancer. The technology is designed to provide an objective result at the point of care, thereby improving the management of cervical disease. Unlike Pap and HPV tests, the device does not require a painful tissue sample and results are known immediately. GT also has an agreement with Konica Minolta Opto, Inc. (KMOT) of Tokyo to co-develop non-invasive products, for the detection of lung and esophageal cancer based on the company's LightTouch non-invasive cervical cancer detection technology. For more information, visit GT's web site www.guidedinc.com. The Guided Therapeutics LightTouch[TM] 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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 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-KA for the fiscal year ended December 31, 2008 and subsequent quarterly reports. |
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