Cervical Cancer is the second most common type of cancer in women worldwide and the leading cause of cancer related mortality in women in developing countries. Early detection and diagnosis can saves lives and reduce the burden on the national healthcare system. We have built a non-invasive research-prototype point-of-care device to detect early cancerous conditions of the uterine cervix. We have tested this prototype in a multi-center pre-pivotal study accruing data from more than 600 women for training our algorithm. We have now started our pivotal study using an FDA reviewed protocol and have collected data from 702 subjects as of this writing. We will also test a pre- production version of our device in this pivotal study. This device, which has now been designed and built as part of a fast track SBIR grant 4R44CA110149, is a cost and size reduced, portable, rugged and more user-friendly than the research prototype. It is identical to the commercial device without incurring the tooling costs necessary to enter the production phase. The current pivotal study data accrual from 720 subjects is funded by our prior Phase II grant award 2R44CA086626. However the FDA has recommended changes in our claims and claim benchmarks resulting in an increase in subject accrual to justify a PMA submission. In this Phase II continuation effort, we will accrue data from an additional 930 subjects. This additional accrual will give us the 1500 subject data required by FDA to meet our claim benchmarks. Upon completing this additional accrual we will continue with the remaining aims of our original grant award viz. validate the algorithm on all pivotal data and prepare and submit the clinical PMA application to the FDA. Cervical cancer is the second most common type of cancer in women worldwide and one of the leading causes of cancer related deaths in women in developing countries. Like all cancers, it is preventable if detected and treated early. Currently, the major obstacles to detection and treatment are inaccurate and painful tests and delays in obtaining results. Spectroscopic diagnosis has the potential of removing all of these obstacles. Thus it not only improves care and quality of life for women suffering from this cancer but also reduces the burden that this cancer poses on health care costs worldwide. ? ? ?
