Multimodal Spectroscopic Evaluation of Cervical Cancer.

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DESCRIPTION (provided by applicant): 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. We have developed non-invasive point-of-care devices to detect early cancerous conditions of the uterine cervix. In a Phase I funded effort we analyzed data obtained with early prototypes to determine device features most relevant to diagnostic performance. We also incorporated into the design device aspects found to be important from our experience with the clinical use of the early prototypes as well as feedback from marketing studies. Using data from 71 patient subjects enrolled for preliminary testing with the validation device we continue to show promising results. For the phase II effort we have proposed device claims that support our market positioning of the device and a comprehensive data accrual and clinical plan to validate our claims. Our phase II effort will conclude with a pivotal trial that includes the pre-production version of our validation device and an FDA PMA application.