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The problem

Every year, more than 5 million patients in the U.S. undergo biopsy procedures to get definitive diagnoses. The goal of the biopsy procedure is to get a sample that is representative of the suspected area. However, 1 in 5 patients have to get repeat procedures because the biopsies were not representative of the suspected area. Most biopsy procedures incorporate a rapid on- site evaluation (ROSE) technique for quality assurance of the sample. However, the current ROSE does not give a clear picture of the quality of biopsy because the technique only allows evaluation of less than 1% of the cells that have “fallen off” of the biopsy. As a result, ROSE is inaccurate 20% of the time, leading to costly and painful repeat procedures. Furthermore, ROSE depletes DNA content from the biopsies, impacting downstream molecular analysis and genetic sequencing. Specialized pathology personnel must be physically present to perform time- consuming and complicated steps for ROSE. Physicians need a more accurate and efficient tool to perform ROSE for quality assurance of biopsy samples

The solution: the I200 microscopy system

Instapath has engineered the I200 microscopy system to image intact biopsy samples without fixation, using simple fluorescent stains. The I200 renders digital images of biopsies within seconds of removal, enabling a more efficient workflow for performing rapid on-site evaluation (ROSE). Instapath also features centralized telepathology evaluation over a secure network, thereby increasing the productivity of highly specialized pathologists and technicians. Utilizing the I200 for ROSE increases the throughput of biopsy procedures and allows more patients to be treated per biopsy suite per day.

The I200 is a structured illumination microscopy (SIM) system optimally configured for clinical applications such as ex vivo biopsy imaging for ROSE. SIM works by optically sectioning fresh tissue to generate subcellular (1.3 micron) images of the intact tissue with high contrast. Fluorescent stains that do not affect downstream histology processing illuminate important pathological features. The frame rate of the I200 is 33 fps, meaning a typical biopsy takes less than 30 seconds to completely image. All images can be reviewed remotely via a zoomable interface.