Theranos FDA Clearance and Milestone Announcement
Theranos, Inc. achieved a significant milestone with FDA clearance for its test system targeting herpes simplex 1 virus IgG. The company's breakthrough finger stick technology and associated test system underwent rigorous review and validation, paving the way for a new era in preventive health care. The detailed breakdown of the study numbers and submissions for FDA approval showcase the meticulous precision and reproducibility of Theranos' innovative approach. Demonstrating lack of cross-reactivity against various samples, Theranos has set a high standard in clinical performance and field robustness.
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Presentation Transcript
HSV-1 510k Approval Company Meeting 07.02.15 this presentation and its contents are theranos property and confidential. 1 1 theranos confidential theranos confidential
Major milestone for Theranos and national preventive health care landscape PALO ALTO, Cal. (July 2, 2015) Theranos, Inc. today announced that it has received the U.S. Food and Drug Administration s (FDA) clearance of its test system and test for herpes simplex 1 virus IgG. 2 2 theranos confidential theranos confidential
Theranos receives FDA clearance and review and validation of revolutionary finger stick technology, test, and associated test system K143236 3 3 theranos confidential theranos confidential
Study Breakdown Just the Numbers 13,754 cartridges run 17,208 man-hours worked (est.) 1,100,320 minutes of protocol run time 78 4s devices used 4,506 CTNs (Capillary Tubes and Nanotainer Tubes) collected 2,750 teaspoons of fluid pipetted 146 documents submitted to FDA 2,931 pages submitted to FDA = 1 enormous FDA clearance ! 4 4 theranos confidential theranos confidential
Studies Submitted for FDA Approval Precision and Reproducibility Cross-reactivity and Interference Reagent and Analyte Stability Matrix Comparison Clinical Performance Field Robustness Studies 5 5 theranos confidential theranos confidential
Studies Submitted for FDA Approval Precision and Reproducibility CV within devices: 9% CV across devices: 12% CV across reagent lots: 11% CV across CTNs: 9% CV across CTN lots: 6% CV across operators: 10% 6 6 theranos confidential theranos confidential
Studies Submitted for FDA Approval Demonstrated lack of cross-reactivity against the following types of samples: Cross-reactivity CMV (IgG) CMV (IgM) Chlamydia trachomatis (IgG) HCV/HBV (IgG) VZV IgG Measles IgG HIV-1 (IgG) Toxoplasma IgG Candida albicans Ag N. gonorrhea Systemic Lupus Epstein Barr Virus (IgG) Epstein Barr Virus (IgM) HPV Rubella (IgG) HSV-2 (IgG) HAMA samples Treponema pallidum Rheumatoid Factor (RF) Anti-nuclear antibody (ANA) Sjorgens Syndrome 7 7 theranos confidential theranos confidential
Studies Submitted for FDA Approval Demonstrated lack of interference from following substances: Interference Heparin Levodopa Methyldopa+1.5h20 Metronidazole Phenylbutazone Doxycycline Acetylsalicylic acid Rifampicin Acetaminophen Hemoglobin Bilirubin Intralipid Acetylcysteine Ampicillin-Na Ascorbic acid Ca-Dobesilate Cyclosporine Cefoxitin 8 8 theranos confidential theranos confidential
Studies Submitted for FDA Approval Matrix Comparison (venous plasma, serum, fingerstick plasma, fingerstick whole blood): 9 9 theranos confidential theranos confidential
Studies Submitted for FDA Approval Clinical Performance in Intended Use Population (adults) Reference POS EQ NEG Total POS 137 0 2 139 Theranos EQ 1 0 1 2 NEG 5 1 113 119 Total 143 1 116 260 95% Interval Confidence Estimate 95.1% (137/144) Sensitivity 90.3 - 97.6 97.4% (113/116) Specificity 92.7 - 99.1 10 10 theranos confidential theranos confidential
Studies Submitted for FDA Approval Clinical Performance in Intended Use Population (pregnant subjects) Reference POS EQ NEG Total POS 188 1 4 193 Theranos EQ 0 1 0 1 NEG 2 2 100 104 Total 190 4 104 298 95% Interval Confidence Estimate 97.9% (188/192) Sensitivity 94.8 - 99.2 95.2% (100/105) Specificity 89.3 - 98.0 11 11 theranos confidential theranos confidential
Studies Submitted for FDA Approval Clinical Performance in Intended Use Population (fingerstick samples) Reference POS EQ NEG Total POS 105 0 2 107 Theranos EQ 0 0 0 0 NEG 3 0 68 71 Total 108 0 70 178 95% Interval Confidence Estimate 97.2% (105/108) Sensitivity 92.2-99.1 97.1% (68/70) Specificity 90.2-99.2 12 12 theranos confidential theranos confidential
Comparison of Theranos HSV-1 IgG assay performance with other cleared assays Bio-Rad Roche DiaSorin Theranos Sensitivity (%) 96.3 96.9 90.3 97.2 Specificity (%) 90.1 91.3 94.2 97.1 13 13 theranos confidential theranos confidential
Studies Submitted for FDA Approval Field Robustness Studies Ambient temperature and humidity Device placed on a titled table-top Sample integrity: hemolysis, clotting, bubbles, short fills Cartridge handling: dropped cartridge, expired cartridge, stored sideways, re-used etc 14 14 theranos confidential theranos confidential
Took Contributions, Late Nights and Weekends from All Teams to Make this Happen: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. Regulatory ELISA Comp Bio Supply Chain CTN manufacturing Systems Integration (SIV) Device Engineering Software Device Manufacturing Reagent Manufacturing Cartridge Manufacturing Phlebotomy and Field Operations 15 15 theranos confidential theranos confidential
We especially congratulate these standout contributions: Laura Hyland: study lead Jessica Pfeilsticker: study lead Uyen Do: specimen lead Sani Hadziahmetovic: software and submission Aaron Lau: cartridges and tips Alphonso Nguyen: cartridges and tips Yiching Siwinski: protocol troubleshooting Tim Kemp: software and hazard analysis Tim Smith: hazard analysis Gina Catalano: regulatory filing Amy Ta: specimen sourcing Nick Menchel: field study coordination Ryan Karpel: field study coordination Tiffany Shu, Kelly Low, Ciara Miranda, Brianna Doyle, Amelia Cooke, Jose Arias, Diane Sosa, Serena Stewart, Benny Morel: sample collection 16 16 theranos confidential theranos confidential
