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Data Summary

COBAS AmpliScreen HBV Test HBV Seroconversion Panel Results and HBV NAT Positive / Serology Negative Donors Larry Pietrelli Director, Clinical Affairs Roche Molecular Diagnostics. Data Summary. Today’s focus:

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Data Summary

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  1. COBAS AmpliScreen HBV Test HBV Seroconversion Panel Results and HBV NAT Positive / Serology Negative Donors Larry PietrelliDirector, Clinical AffairsRoche Molecular Diagnostics BPAC Meeting 7/21/05 COBAS® AmpliScreen

  2. Data Summary • Today’s focus: • Overview of the COBAS AmpliScreen HBV Test Performance on 40 HBV Seroconversion Panels Compared to HBsAg Tests • Clinical Study Summary of Donors Found HBV DNA Positive / HBsAg & anti-HBc Negative & Enrolled in Follow-up Studies BPAC Meeting 7/21/05 COBAS® AmpliScreen

  3. Seroconversion Panel TestsDetection of HBV DNA Prior to Ortho HBsAg Test System 3 On average, the COBAS AmpliScreen HBV Test detected HBV 15 days with Mini-pool Test and 20 days with Single Unit Test earlier than the Ortho HBsAg Test System 3. There was no case in which serological tests detected HBV prior to NAT. . BPAC Meeting 7/21/05 COBAS® AmpliScreen

  4. Seroconversion Panel TestsPanel #24 Detailed Test Results BPAC Meeting 7/21/05 COBAS® AmpliScreen

  5. Seroconversion Panel TestsPanel #40 Detailed Test Results BPAC Meeting 7/21/05 COBAS® AmpliScreen

  6. Seroconversion Panel TestsPanel #39 Detailed Test Results BPAC Meeting 7/21/05 COBAS® AmpliScreen

  7. Summary of COBAS AmpliScreen HBV Test vs. Ortho HBsAg ELISA Test System 3 with 39 HBV Seroconversion Panels • * One seroconversion panel was not included in the calculations which was detected by the COBAS AmpliScreen HBV Test 108+ days prior to the Ortho HBsAg ELISA Test System 3. BPAC Meeting 7/21/05 COBAS® AmpliScreen

  8. Clinical Trial Summary BPAC Meeting 7/21/05 COBAS® AmpliScreen

  9. Follow-up Study • Donor enrolled in the follow-up study were to return weekly for the first month and then monthly for 5 months for a total of 6 months • Testing was to include the following: • IgM anti-HBc • anti-HBc (total) • anti-HBs • HBsAg • HBV DNA BPAC Meeting 7/21/05 COBAS® AmpliScreen

  10. Potential Window Cases • 23 Donors were HBV DNA + / HBsAg - / Anti-HBc – - 14 were enrolled into the follow-up study - 2 confirmed Window Period cases • 12 presumed false positive due to persistently negative Anti-HBc, HBsAg and HBV DNA • 9 subject declined follow-up (calculated as false positive for sensitivity/specificity determination) BPAC Meeting 7/21/05 COBAS® AmpliScreen

  11. Follow-up Subject AA110001 26 year old male repeat donor with no know risk factors BPAC Meeting 7/21/05 COBAS® AmpliScreen

  12. Follow-up Subject DA120001 49 year old female, repeat donor, health care worker, previously vaccinated BPAC Meeting 7/21/05 COBAS® AmpliScreen

  13. Additional Window Cases Detected Post Clinical Study • Three of the five sites continued screening for HBV under the IND after conclusion of the Clinical Study • Three additional window period cases identified BPAC Meeting 7/21/05 COBAS® AmpliScreen

  14. Follow-up Subject LA150001 27 year old male repeat donor, multiple high-risk male sexual partners BPAC Meeting 7/21/05 COBAS® AmpliScreen

  15. Follow-up Subject LA150002 29 year old male repeat donor, only possible risk factor was acupuncture once a week for 8 weeks prior to donation BPAC Meeting 7/21/05 COBAS® AmpliScreen

  16. Follow-up Subject LA151303 50 year old male repeat donor BPAC Meeting 7/21/05 COBAS® AmpliScreen

  17. Conclusions from the Window Period Cases Identified • Four of the five window period cases seroconverted to HBsAg positivity. Time from first minipool NAT positivity to HBsAg Positivity Ranged from 7 to 17 with a median of 11 days. • One donor who was previously vaccinated against HBV failed to seroconvert. • 12 donors were negative for all markers at the end of the 6 month follow-up period and were classified as false positive BPAC Meeting 7/21/05 COBAS® AmpliScreen

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