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-centre study at six sites in the United States 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 United States Food and Drug Administration and is currently available for investigational use only.
"The Cerviscan system has the potential to greatly improve the accuracy and speed with which we detect cervical disease", according to Dr. Alex Ferenczy, who presented the study at the conference. "This system can provide an immediate answer for both the patient and the physician. This rapid, accurate response could allow the physician to treat the patient during the same visit. The beauty of Cerviscan is that it provides a great means to improve compliance with therapy. This is very important because nearly one-third of patients fail to return for treatment of their cervical disease."
Dr. Ferenczy is a Professor of Pathology and Obstetrics & Gynaecology at McGill University and is Head of Gynaecologic Pathology and Colposcopy at the Jewish General Hospital, both in Montreal. He is also LifeSpex' medical advisor and chairman of its Clinical Advisory Board. Dr. Ferenczy has served as an editorial board member for multiple journals in the field of obstetrics, gynaecology, and gynaecologic pathology and is internationally known as one of the most senior and well-respected clinicians, colposcopists, and researchers in the cervical cancer field.
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 United States. 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 United States. 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.