About three years ago Guided Therapeutics (GT; Norcross, Georgia) was at a crossroads. Faced with either staying with its diabetes segment or focusing totally on cancer, the company opted to go with the latter. After selling off its diabetes segment the company began to focus on developing rapid and painless tests for the early detection of disease that leads to cancer.
Now the company is seeing the choice payoff, with a device that promises to diagnose cervical cancer better than most of the traditional methods and tests available on the market now.
The LightTouch Cervical Cancer Detection Device was recently evaluated in a pivotal clinical trial by the FDA. The study indicated that is able to diagnose those individuals that conventional tests aren't able to pick up and that LightTouch catches those patients that fall through the cracks.
"We have said that we've performed better than the Pap test," Mark Faupel, PhD, president/CEO of GT told Medical Device Daily. "We're catching the cases that are being missed." The results were recently presented at NCI's inaugural Investor Forum at Boston University. GT was selected as one of NCI's top innovators and to date, has been awarded nearly $6 million in six consecutive grants from the organization to further develop cancer detection tests.
In the new LightTouch study, conducted at six U.S. clinics and with an enrollment of about 2,000 women, 32% of cervical precancers and cancers were missed by the current method of human papillomavirus (HPV) testing and colposcopy, while only 19% of biopsy samples indicated the presence of these diseases.
Similarly, the ASCUS/LSIL Triage Study for Cervical Cancer (ALTS), sponsored by National Cancer Institute (Rockville, Maryland) indicated that about 35% of disease was missed and only about 26% of biopsies found significant disease. Both ALTS and the newly released data from the LightTouch study show similar results.
The company remained tightlipped regarding how well the test performed, but added that the full results of LightTouch's efficacy would be revealed sometime next year.
"ALTS sheds new light on problems plaguing cervical disease management after a woman undergoes Pap screening and adjunctive tests, such as HPV and colposcopy," Faupel said. "Our FDA study confirms the ALTS results and shows the high rate of false positives and false negatives using conventional procedures and technology."
Organized and funded by NCI, the ALTS study 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 results known as ASCUS and LSIL. About three million women in the U.S. are diagnosed with ASCUS and LSIL each year.
The company said that the 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. The device utilizes fluorescent spectroscopy, which finds biopsies, and reflective spectroscopy, which views the formation of biopsies in the body.
Results are run through an algorithm, which was developed by the company, to determine the degree and scope of the cancer.
Since development of the LightTouch began, more than 3,000 women have been tested with the LightTouch, including nearly 2,000 women who were enrolled in 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.
Plans call for the company to file for a PMA sometime next year. LightTouch has already received CE mark approval.
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