Products
LUMA System
LUMA® Cervical Imaging System The LUMA Cervical Imaging System was developed to significantly improve the detection of high-grade precancerous cervical abnormalities that have the potential of becoming invasive cancer. Based on data from the National ALTS study, it is estimated that about 200,000 women with precancerous disease go undiagnosed each year.
The LUMA System provides a safe and effective method, that when used as an adjunct to colposcopy, will find at least 26% more high-grade precancerous disease than the gold standard colposcopy in women with ASC and LSIL Pap tests.
Cervical Cancer
In the U.S. alone, over $6 billion is spent annually on the screening, diagnosis and treatment of women with cervical cancer. Diagnosing cervical cancer is often a long and uncertain process, requiring repeat visits by anxious patients. Approximately three million colposcopy procedures are performed annually, with many repeat exams aimed at arriving at a definitive diagnosis. The U.S. colposcopy market alone is approximately $1 billion annually. The introduction of HPV-DNA testing is expected to be a catalyst for this market, increasing the number of colposcopy procedures performed each year. The LUMA System offers a reliable, easy-to-use diagnostic exam that provides rapid answers for clinicians and their patients by greatly reducing missed diagnosis and allowing for early-stage decision and treatment of cervical cancer precursors.
Cervical cancer is the sixth most common form of malignancy in U.S. women with 10,000 new cases per year. An additional 600,000 women are identified each year as having pre-invasive cervical cancer. Early detection of these precancerous conditions allows clinicians to treat patients more effectively, less expensively, and with fewer lasting health effects. Currently, women with abnormal Pap tests are diagnosed with a colposcope, a decades-old, low-powered binocular microscope technology, which provides only a limited visual assessment of the cervix. In fact, a recent large-scale National Cancer Institute-sponsored clinical trial demonstrated that colposcopy failed to detect 33% of high-grade precancerous lesions in women referred with questionable Pap results. LUMA's ability to detect close to 30% more ASCUS/LSIL cervical cancer precursors than colposcope alone provides clinicians with an extremely valuable tool in the fight against cervical cancer than colposcopy alone.
More than three million U.S. women have abnormal Pap tests each year, and they typically undergo a series of repeat, stressful and expensive diagnostic tests. For women with precancerous lesions, the long diagnostic cycle can allow the disease to progress and develop into invasive, life-threatening cancers. By providing a more definitive test, the LUMA System will allow clinicians to more effectively manage and treat millions of women who are at risk of cervical cancer.
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