CEO SUMMARY: Guided Therapeutics, Inc. of Norcross, Georgia is working to develop proprietary technology into an improved method for detecting cervical cancer. It wants to give ob-gyns and other physicians an instrument system that can be used in the office to provide real-time results to patients. The procedure will be non-invasive and it will determine results by using both morphological and biochemical analysis.
IT IS UNIVERSALLY RECOGNIZED that the Pap test, originally developed by Dr. Georgios Papanikolaou in the early 1940s, has been the most successful screening test in the history of medicine.
Because of the Pap smear, cervical cancer deaths in the United States and other developed countries have fallen dramatically. But, as a screening test, pathologists are all too familiar with the problem of the false positives and false negatives generated by the conventional Pap test’s relatively low levels of sensitivity and specificity.
Improving upon the conventional Pap smear continues to be a goal of several biotech companies. One of those firms is Guided Therapeutics, Inc., a subsidiary of SpectRx, Inc., based in Norcross, Georgia.
Guided Therapeutics is developing a device for detecting cervical cancer that ob-gyns can use in their offices. The device is designed to provide several benefits. First, it would be a patient-friendly, non-invasive procedure and require no tissue sample or laboratory analysis. Second, it would improve accuracy of diagnosis while the patient is still in the office, providing peace of mind to the patient with a negative diagnosis, or immediate start of treatment for patients with positive diagnoses. Third, the device is designed to be used as a colposcope. This would allow the ob-gyn to be reimbursed for appropriate procedures that incorporate the instrument.
Guided Therapeutics wants its new diagnostic device to significantly improve patient care, streamline and boost practice productivity, and contribute to enhanced practice revenues for ob-gyns and other physicians who treat women. Guided Therapeutics has begun the clinical studies needed to support a Pre- Market Application (PMA) with the Food and Drug Administration.
Guided Therapeutics is using spectral analysis technology in its product. The device “uses proprietary technology to identify cancers and precancers painlessly and non-invasively by analyzing light reflected from the cervix.”
According to the company, “the device creates an image of the cervix that highlights the location and severity of disease. 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.”
Key Patent Was Granted
In December, Guided Therapeutics received a patent for a key component of its technology, which measures both biochemical and structural changes in tissue. The company developed the technology through work partially funded by research and commercial development grants from the National Cancer Institute. This technology combines morphological analysis of the cell structure with biochemical detection supported by advances in genetic and molecular diagnostics. To date, approximately 1,600 women have undergone testing with prototypes of the device.
“We envision the device will first be used as an adjunct to the Pap smear test,” said Bill Wells, Director of Communications at SpectRx. “Physicians would use it to winnow through the false positives and false negatives of Pap screening and reduce the number of unnecessary procedures.”
The as-yet unnamed device is similar to a colposcope, except that it will produce both a visual view of the cervix and a photonic view. “Using spectroscopy, the photonic technology analyzes the reflected light to distinguish biochemical and morphological changes in cells,” Wells said. “The light source has a broad spectrum similar to natural light.
“The cervical cancer screening tool will do real-time diagnosis of a cervix to detect cancer and precancers,” Wells said. “Using this diagnostic information, the ob-gyn would be able to treat the patient, refer for treatment, or if no cancer or precancer is detected, then he or she would be able to offer immediate relief of concern to the patient. That contrasts with Pap testing, where results are generally not known for several days.
“Since the device can be used as a colposcope, it will lend itself to reimbursement,” Wells continued. “And, from a competitive perspective, we hope it would replace the colposcopy tools now in use. But, of course, the colposcope has an established market and this is a new product that would face all the usual challenges any new product would face.”
While analyzing the cervix for bio-chemical and morphological abnormalities, the device would produce an image on a computer screen that could be stored and shared with other physicians. The image also could be archived, thus allowing a physician to analyze results over time.
This year, Guided Therapeutics will complete collecting data on how the device works and submit the results to the FDA in its Pre-Market Application (PMA). “Our current timetable is to have the product on the market in the United States in 2007,” noted Wells.
Like other companies developing technology to improve the detection of cervical cancer, Guided Therapeutics recognizes the potential for a successful product to generate significant sales volume. It hopes that a diagnostic procedure that is non-invasive, provides the patient with an immediate result, and makes money for the ob-gyn will catch on quickly. These would all be improvements over current cervical cancer detection methods.