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NF-800 is a novel diagnostic optical imaging probe composed of an anti-HER-2 Nanofitin conjugated to the near-infrared fluorophore IRDye800CW. Nanofitins are small (approx. 7 kDa), hyperstable antibody mimetics derived from the Sac7d protein of *Sulfolobus acidocaldarius*. NF-800 specifically targets the Human Epidermal Growth Factor Receptor 2 (HER-2) at an epitope distinct from those targeted by Trastuzumab and Pertuzumab, allowing for potential use in patients already receiving these standard-of-care antibodies. Due to its small size, NF-800 exhibits rapid biodistribution and renal clearance, providing high-contrast tumor imaging shortly after administration. It is intended for non-invasive detection of HER-2 expression, therapy monitoring, and fluorescence-guided surgery (FGS) to assist in the identification of tumor margins and lymph node involvement.
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