Notes

Slide Show

Outline

1	AMDM – IVD Focus XIV
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3	Seradyn Manufacturing Location
4	Seradyn Facilities - Indianapolis
5	Who Is Seradyn?
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7	Fisher Scientific International Inc.
8	Key Seradyn Assays
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10	Management of new therapeutic drugs will be an integral part of the long term treatment of patients Steps in Meeting Patients and Physicians Need
11	Seradyn, Inc. Quality System Design Control ISO 13485:2003 Certified QSR Compliant CADCAS Compliant TUV ISO Registrar FDA Registrations Contract Manufacturers
12	Overview of Product Development Process (F04-012)
13	The Novartis/Seradyn Partnership
14	The Novartis/Seradyn Partnership
15	Assay Development Goals
16	What Is the Kit Format?
17	Performance Evaluation Testing Typical Calibration Curve Linearity Accuracy Metabolites Method Correlation
18	Performance Evaluation Testing cont… Fresh vs. Frozen (Sample stability study) Analytical Sensitivity (LDD) Functional Sensitivity (LOQ) Interference Precision
19	Typical Calibration Curve
20	Metabolites
21	Metabolites
22	Samples: Fresh Kidney specimens from 111 individual patients Slope = 1.00 (0.90 to 1.09) y-int = -0.514 (-1.01 to 0.074) Corr Coef (R)= 0.95 R²= 0.91 N=111
23	Samples: Archived Heart specimens from 68 individual patients Slope = 1.05 (1.00 to 1.10) y-int = -0.69 (-0.93 to –0.41) Corr Coef (R)= 0.99 R²=0.98 N=126
24	Study with Fresh and Frozen Samples Purpose: To investigate any degradation of sample or lack of it by testing fresh and frozen samples side by side using the immunoassay. Sites: Cleveland Heart Center Ohio State University University of Wisconsin
25	Study with Fresh and Frozen Samples There was no trend in kidney sample degradation when stored frozen for 28 days or refrigerated for 2 weeks.
26	Study with Fresh and Frozen Kidney Samples cont…
27	Fresh vs. Frozen Study Kidney Patients cont… Graphical representation of each patient sample
28	Fresh vs. Frozen Study cont… Samples collected from 13 heart transplant patients at the Cleveland Clinic Samples returned to Seradyn for analysis same day of draw Samples aliquoted and tested at each time point Results compared to day 0 for percent recovery.
29	Fresh vs. Frozen Heart Patients Study cont…
30	Fresh vs. Frozen Study cont… Graphical representation of each patient sample.
31	Analytical Sensitivity (LDD) This was performed by running the zero calibrator N=20 times against a calibration curve then performing the following calculation:
32	Functional Sensitivity (LOQ)
33	Low and High Hematocrit Interference
34	Interfering Substances
35	Total Precision Each sample was assayed in duplicate 2 runs per day for 20 non-consecutive days. Recalibration was performed 3 times as needed. Data was collected and analyzed per NCCLS guidelines.
36	Assay Performance Specifications
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38	What Regulatory Filings Are Needed?
39	How Is the Assay Made Available?
40	Certican® Kit
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