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Automated Tissue Image Systems
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Automated Tissue Image Systems (ATIS) are computer-controlled automatic test equipment (ATE) systems classified as medical device and used as pathology laboratory tools (tissue-based cancer diagnostics) to characterize a stained tissue sample embedded on a bar-coded glass slide. After careful tissue sample preparation on to a slide, characterization of the sample is based on detection of cellular traits (color, shape, and numeration) observed in high-powered microscopic visual images (so-called bright-field microscopy).
A typical ATIS application includes measuring aggregate cellular activity or expression in a breast cancer tumor (carcinoma) biopsy to determine stage of disease for the appropriate course of treatment prescription. The technologies utilized in all the seven basic functions of Automated Tissue Image Systems are state-of-the-art and includes: Specimen Preparation; Image Acquisition; Image Analysis; Assessment Reporting; Data Storage Management; Network Communication, and System Self-Diagnostics.
Peripheral system equipment includes, but is not limited to, automated staining, hybridizing, pressurizing, and heating of the tissue sample. The integrated system software is complex and highly regulated, as is the entire system, by the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), under Code of Federal Regulations (CFR) Title 21. As such, stringent compliance to validation and verification (V&V) methods with respect to safety, efficacy, and documentation is paramount.
Automated Tissue Image Systems (ATIS) redefine typical Histology Laboratories (HL), in a similar way that ATE systems redefined manufacturing testing, by applying Lean Manufacturing (LM) & Six Sigma (SS) tools to the Histology Laboratory production floor. Production in this context fundamentally means turn-around time and diagnosis quality. Although there are exceptions, typical HL today do not utilize modern industrial manufacturing lean methods (concurrent engineering methods) that provide world class manufacturing environments in other industries, they (HL) lack LM/SS methodology, automation, and connectivity. ATIS provides the automation component of a modern, safe, effective, and efficient Histology Laboratory system.
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