February 15, 2005, Atlanta, GA--SpectRx is partnering with Emory University (also of Atlanta) as part of a grant to Emory from the Georgia Research Alliance (GRA) to support U.S. Food and Drug Administration pivotal clinical trials for a noninvasive imaging cervical-cancer-detection device. The $64,700 matching grant will be used for the clinical trial of the SpectRx-developed technology at Atlanta's Grady Memorial Hospital under the guidance of Lisa Flowers of Emory University.
The device identifies cancers and precancers painlessly and noninvasively by analyzing light reflected from the cervix, creating 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 test does not require a tissue sample or laboratory analysis, and results are available immediately. To date, more than 1,000 women have been tested with prototypes of the devices. Research and commercialization of a product are being funded by grants from the National Cancer Institute (NCI; Bethesda, MD).
A prepivotal clinical study of the technology, sponsored by the NCI, indicated that the noninvasive test could reduce by 55% the number of unnecessary followup procedures as a result of false positive Pap-test results. The potential savings to the U.S. healthcare system could be as high as $181 million annually if the technology is widely adopted. According to published reports, cervical cancer is the third most common cancer among women worldwide. Globally, there are approximately 471,000 cases of cervical cancer diagnosed annually and approximately 233,000 deaths per year. Approximately 60 million Pap tests are performed annually in the United States. The company estimates the annual global market potential for a noninvasive cervical-cancer test to be more than $1.0 billion.
"This new technology offers the potential to overcome many of the barriers to early detection of cervical cancer that exist today," said Flowers. "It could eliminate the anxiety of waiting days for test results and many of the false positive results that are a burden on the patient and the healthcare system."
The Georgia Research Alliance, a partnership of industry, Georgia's leading research universities and state government, drives the state's strategy for turning world class science into economic advances. Launched last year, the Georgia Research Alliance Innovation Fund is designed to foster long-term partnerships between Georgia companies and the state's research universities. The primary criteria for selection as an Innovation Fund participant is the company's potential for developing new technologies that will boost the state's economy.