By Myra Guevara, Research Intern
UPDATE: This post originally titled: “FDA approves new cervical cancer screening technology,” incorrectly implied that the FDA had approved the screening technology. In actuality, it has only been approved for review.
“Receiving the ‘suitable for filing’ letter from the FDA is the first significant milestone in the regulatory review process and means that our application was sufficiently complete and is ready for substantive review,” said Mark L. Faupel, Ph.D., President and CEO of Guided Therapeutics. “This brings us one step closer to realizing our goal of improving the early detection of cervical disease and reducing the false positives and unnecessary biopsies that result with the current standard of care.”
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Guided Therapeutics, Inc. recently received a premarket approval from the FDA for a new technology that could improve the manner in which cervical cancer is screened and tested. The new device, called LightTouch uses biophotonic technology which claims to be painless and can detect cancer earlier than the current methods of cervical cancer screening. According to Biomedreports:
“The National Cancer Institute-sponsored clinical trial demonstrated that Colposcopy failed to detect 33% of high-grade precancerous lesions in women referred with questionable Pap results.”
Biophotonic technology uses light to create images of cervical cells’ biochemical and morphological changes. LightTouch does not require laboratory testing and analysis, which would not only save time but money. Additionally, it is designed to provide immediate results, is more accurate than pap smears and HPV tests, and painless. Early detection is a major component in reducing the mortality of cervical cancer.
Results of a key trial of LightTouch showed that:
- LightTouch detected cervical disease up to two years earlier than Pap test, HPV (human papillomavirus) test, colposcopy and biopsy;
- LightTouch detected 86.3% of cervical disease cases that had been missed by Pap, HPV tests and biopsy;
- LightTouch would have reduced the number of avoidable biopsies by about 40 percent.
LightTouch has the potential to be a revolutionary measure that would not only be cost-efficient, but it could save the health care system millions of dollars and hours in unnecessary biopsies and colposcopys.
Pap smears, HPV tests and vaccines should not be disregarded. It is important for women of all ages to get frequently tested. However LightTouch, if it is as effective as Guided Therapeutics states, could change the face of cervical cancer detection.
For more information:
GuidedTherapeutics Abstracts, Posters and Presentations from the 2010 American Society of Colposcopy and Cervical Pathology biennial meeting
By Myra Guevara, Research Intern
