3.6.14 Narrative

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FlowDx, a Clinical Cytometry Analysis Software Project is designed to create a new, more efficient, and more effective way of analyzing cells for the presence of cancer, HIV/AIDS, and other diseases, using a fully automated software system. Using Magnetic Gating, Probability Clustering, Artificial Neural Networks, and Support Vector Machines (SVM), Tree Star software will analyze the cell samples from patients at a much faster rate and with fewer false positives and negatives than the manual method now in use.

The FlowDx Project

• Fits the "translational medicine" model of the NIH Roadmap
• Reduces error in the diagnosis of cancer and other diseases
• Speeds results to physicians. Patients learn the outcome more quickly. Therapeutic intervention is faster.
• Accommodates large-scale research by allowing greater volumes of complex data to be much more quickly examined, compared, and quantified
• Reduces the expense of cell analysis by as much as 50%
• Conforms to 21CFR Part 11 guidance