Hyperspectral device better for cervical cancer detection

NORCROSS, GA--Because routine Pap tests are often unreliable and tend to miss disease and create false positives with expensive followup, Mark L. Faupel, PhD, president and CEO of Guided Therapeutics, is betting that his company's LightTouch Cervical Neoplasia Detection System will be a better alternative.

NORCROSS, GA--Because routine Pap tests are often unreliable and tend to miss disease and create false positives with expensive followup, Mark L. Faupel, PhD, president and CEO of Guided Therapeutics, is betting that his company's LightTouch Cervical Neoplasia Detection System will be a better alternative. LightTouch is a non-invasive, hyperspectral imaging spectroscopy (HIS)-based approach to detecting cervical cancer. Although full details of a just-concluded FDA pivotal clinical trial (conducted at 7 U.S. clinics with 2000 patients at high risk for cervical cancer) will be made available in March, the trial has already revealed that current methods miss nearly a third of cervical precancers and cancers. And of the biopsies performed on patients who tested positive via these methods for cancer or precancer, only 19% indicated presence of the diseases. The trial results correlate well with those of a 2005 study sponsored by the National Cancer Institute (NCI).

The system includes a handheld device that connects to a base unit via fiber-optic cables for bi-directional transmission of light. The base contains a xenon arc lamp, filters and lenses, and a CCD camera. A computer provides control and data processing. Faupel says, however, that the "key spec" is the dramatically reduced cost of the technology. Ten years ago the $20,000 system would have cost $60,000 to $100,000. In fact, cost effectiveness is a major reason Guided Therapeutics has been able to secure approximately $6 million in six consecutive grants from the NCI, says Faupel.

In a single minute, LightTouch scans a matrix of equally spaced points over a one-inch diameter of the cervical area, acquiring individual spectra for each cell component. For cervical tissue reflectance measurements, light ranging from about 350 to 900 nm is applied. For tissue fluorescence measurements, light is bandpass filtered to limit exposure to 300 to 500 nm. Each wavelength is applied automatically under software control in a predetermined order and scan pattern. Alterations in fluorescence spectra indicate metabolic changes associated with disease, while abnormal reflectance and scattering highlight disease-induced structural changes.

The technology has already received a CE mark and is undergoing FDA premarket review. Guided Therapeutics anticipates a 2010 launch.

The technology can apply to detection of other forms of cancer, too, and since mid-2007 Guided Therapeutics has been collaborating with Konica Minolta Opto (Tokyo, Japan) to co-develop additional products for the detection of lung and esophageal cancer.

--Barbara G. Goode


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