Noninvasive multiphoton imaging of subcellular structures with color contrast for rapid detection of skin cancers

Nonmelanoma skin cancer (NMSC) represents the most common form of cancer in the human body. The method for diagnosing and treating NMSCs requires a skin biopsy that is processed and stained for analysis on a standard optical microscope. This process is painful for patients, and the invasiveness of biopsy introduces a delay into NMSC detection, which contributes to patient morbidity and adds substantial cost to the healthcare system. EnSpectra Health, Inc (Enspectra) aims to address the unmet clinical need for a better method to detect NMSCs earlier. This Phase IIB application builds on the progress of awarded Phase I and Phase II projects (NCI, 2R44CA221591-02A1). In Phase I of this grant, EnSpectra demonstrated the feasibility of a portable, skin-imaging microscope for human clinical studies (Aim 1), developed software for data acquisition, image processing, and improved user interface (Aim 2), and demonstrated in 5 human subjects with basal cell carcinoma (BCC) the ability to detect pathologic features of BCC (Aim 3). EnSpectra has created the first fiber coupled multiphoton microscopy (MPM) system for in vivo imaging of skin cellular anatomy. In Phase II of this grant, EnSpectra advanced the development of its portable, skin-imaging microscope (Aim 1), developed a library of slide images of targeted skin diseases comparing MPM to traditional histology (Aim 2), and is on track to complete in vivo human performance testing (Aim 3) prior to the Phase II end date. The completion of the Phase II aims will enable EnSpectra to build clinical evidence in to support a 510(k) submission for United States Food and Drug Administration (FDA) clearance. In this Phase IIB proposal EnSpectra will accomplish two aims: Aim 1) Develop and manufacture 8 portable, skin-imaging microscopes for commercial readiness (12 months), Aim 2) Conduct clinical trial to support reimbursement body of literature (24 months).