Bothell, WA -- LifeSpex, Inc. has announced the results of a major new study on cervical cancer management which showed that LifeSpex' Cerviscan system found significant high-grade cervical disease missed by expert colposcopy. The study was presented recently at the 2nd International Conference in Cervical Cancer in Houston, Texas, a conference sponsored by the M.D. Anderson Cancer Center and the National Cancer Institute.
Colposcopy is the widely-used standard method for detecting cancer and its precursors on the cervix of women found to have an abnormal Pap test. Colposcopy has been reported in other studies to miss as much as 55 percent of high-grade cervical disease. If not found and treated early, high-grade cervical disease can lead to invasive cervical cancer which has a very high mortality rate. Early detection of cancer enables a higher quality of care and greatly limits the massive costs of late-stage treatment and long-term care.
In a large, multi-center study at six sites in the U.S. and Canada, the safety and effectiveness of Cerviscan was studied on 222 patients with a previous abnormal Pap test. When used together, the combination of Cerviscan and high magnification colposcopy detected 95 percent of high-grade cervical disease compared to an 82.5 percent detection rate in this study for colposcopy alone. Cerviscan detected 71 percent of the high-grade cervical disease missed by colposcopy. The findings demonstrated that Cerviscan, when used alone or with colposcopy, can play an important role in the early detection of high-grade cervical disease.
Cerviscan also showed an overall performance of 88 percent for sensitivity, which measures the ability to correctly identify disease, and 80 percent for specificity, which measures the ability to identify the absence of disease. By comparison, in several recent comparable studies colposcopy has shown a 72 percent sensitivity and a 69 percent specificity.
Cerviscan is a small, inexpensive instrument developed by LifeSpex, Inc., which has the potential to detect pre-cancerous disease at the point-of-care before it can progress to invasive cervical cancer. Cerviscan testing is easily performed in a physician's office and does not require invasive sampling or laboratory analysis. A woman could receive a Cerviscan exam and get an answer regarding her disease status within minutes. LifeSpex estimates that the worldwide market for a non-invasive cervical cancer detection method is $3-4 billion. The Cerviscan system has not yet been approved by the U.S. FDA and is currently available for investigational use only.
The Cerviscan system incorporates advanced biophotonic technology to provide a "virtual" biopsy of cervical tissue. This light-based system reads fluorescent signals from cervical tissue and uses proprietary software to provide the physician with an objective map of diseased areas of the cervix and preferred locations for biopsy. By contrast, the colposcopy procedure is a subjective, visual examination of the cervix using a high-power microscope that requires extensive training and a large volume of patients to acquire and retain expertise.
Even in expert hands, colposcopy may fail to detect high-grade cervical disease particularly if the lesions are small. Colposcopy relies on the use of multiple biopsies which are expensive, painful and can take 10 to 14 days to provide an answer. There are approximately 2.5 million colposcopy exams performed per year in the U.S.
LifeSpex plans to conduct additional clinical studies that will be used as the basis for a Pre-Market Approval (PMA) submittal to the U.S. FDA for approval to market Cerviscan in the U.S. The company will begin these studies later this year and expects to have Cerviscan in the market in approximately two years.
LifeSpex, Inc. is a medical device company using advanced biophotonic technology to detect cancer in its earliest stages. The company's proprietary Evoked Tissue Florescence (ETF) technology provides a broad platform for identifying cancer and pre-cancerous disease in both screening and diagnostic applications.
LifeSpex is focusing initially on the cervical cancer market but also intends to develop new products for skin, oral, colon, lung and other cancers. The company is supported by a strong group of financial and strategic healthcare investors including Vanguard Ventures, Johnson & Johnson Development Corporation (JJDC), Ascent Medical Technology Fund and Centennial Ventures.
For more information, visit www.lifespex.com