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  "notes": "The slide outlines a clear path from clinical testing at UT Southwestern to an FDA 510(k) filing by Q3 2022.",
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      "text": "Studies will document Symphony performance versus standard of care",
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      "text": "*Including Regulatory pathways ( (510(K) or de novo), to be determined with FDA, or any other alternative paths including EUA = Emergency Use Authorization, RUO = Research Use Only, LDT = Lab Developed Test",
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      "text": "Testing Program: Reference Range Study, Cut-Off Value Study, Cut-Off Validation Study, Analytical Testing. Testing Sites: UT Southwestern Medical Center, Zale Lipshy Pavilion Hospital, William P. Clements Jr. University Hospital, Parkland.",
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      "text": "Milestone: Initial Testing Program at UT Southwestern (Underway), UT Southwestern Testing Program results form the basis of FDA Pre-submission application (January 2022), Conduct an expanded Testing Program (Q1-Q3:2022), File an FDA 510(K) application for the use of IL-6 in sepsis (Q3: 2022)",
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