Continuity of care heuristic model for sequential HPV testing over 3 tests with limited or extended genotyping

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1 Continuity of care heuristic model for sequential HPV testing over 3 tests with limited or extended genotyping Jeff Andrews, MD, FRCSC Worldwide Medical Director for Women s Health & Cancer BD Diagnostic Systems, BD Life Sciences Sparks, MD, USA

2 Disclosures Full-time employee of BD

3 The first hrhpv test result

4 The first hrhpv test result: underlying explanations

5 The first hrhpv test result: preceding explanations Copyright protected by Jeff Andrews, BD

6 hrhpv negative results, serial rounds Copyright protected by Jeff Andrews, BD

7 hrhpv negative results, serial rounds, 5-year CIN3+ risks by P. Castle, at al Ann Intern Med % 0.10% 0.08% 0.06% 0.04% 0.02% 5-year risk of CIN % 1st 2nd 3rd 5-year risk CIN % 5-year risk CIN % 5-year risk CIN % Castle P, et al. Effect of Several Negative Rounds of Human Papillomavirus and Cytology Co-testing on Safety Against Cervical Cancer: An Observational Cohort Study. Ann Intern Med. 2018;168(1):20-29.

8 hrhpv positive results, serial rounds Copyright protected by Jeff Andrews, BD

9 NILM-hrHPV positive results, serial rounds, 5-year CIN3+ risks by NJ Polman, at al Br J Cancer year risk CIN3+ 0.2% 5-year risk CIN3+ 2.0% Polman NJ et al. HPV-positive women with normal cytology remain at increased risk of CIN3 after a negative repeat HPV test. Br J Cancer. 2017;117(10):

10 hrhpv positive results, serial rounds Copyright protected by Jeff Andrews, BD

11 hrhpv with partial genotyping only, 3 serial tests, 8 possible result sets Test year 2 years 3 years 4 years 6 years Test 2-12mo Test 3-12mo Pos Pos Pos Pos Pos Neg Test 2-3yr Test 3-12mo Test 3-3yr Pos Neg Pos Pos Neg Neg Neg Pos Pos Neg Pos Neg Copyright protected by Jeff Andrews, BD LBC Triage to Colpo or Colposcopy 12-month Explanation(s) follow-up infections with new genotypes All after persistence new infection or reactivation 16/18 Other 12 after infection persistence or new infection All after infection Return to screening paradigm Screen in 3 years Screen in 3 years Screen in 3 years Neg Neg Pos new infection 16/18 Other 12 Neg Neg Neg no evidence of infection Screen in 3 years

12 hrhpv with genotype-specific tracking, 3 serial tests, 14 possible result sets 0 1 year 2 years 3 years 4 years 6 years Test 1 Test 2-12mo Test 3-12mo Test 2-3yr Test 3 Test 3-3yr Treatment at Colpo Colpo +/- treatment Use planned cotest result to triage to Colpo or 12mo Pos Pos-same Pos-same persistence 16,18,45 31,33,52,58 35,39,51,56,59,66,68 initial persistence, followed by clearance, & by new all GTs; assumes Pos Pos-same Pos-diff infection colpo clearance, new infection, Pos Pos-diff Pos-same then peristence 16,18,45 31,33,52,58 35,39,51,56,59,66,68 clearance, new infection, all GTs; assumes Pos Pos-diff Pos-diff clearance, new infection colpo Pos Pos-same Neg after peristence Copyright protected by Jeff Andrews, BD Use planned cotest result to triage to 12mo or screen all GTs; assumes colpo Pos Pos-diff Neg after two infections all GTs Pos Neg Pos-same reactivation 16,18,45 31,33,52,58 35,39,51,56,59,66,68 Pos Neg Pos-diff clearance, followed by new infection all GTs Pos Neg Neg after infection Screen Neg Pos Pos-same persistence 16,18,45 31,33,52,58 35,39,51,56,59,66,68 Neg Pos Pos-diff clearance and new infection all GTs; assumes colpo Neg Pos Neg after infection all GTs Neg Neg Pos new infection all GTs Neg Neg Neg no evidence of infection Screen Return to screening paradigm

13 Thank you Co-author: Charles Cooper, MD Acknowledgement: I stood on the shoulders of these giants ideas: Patti Gravitt, PhD Henry Kitchener, MD, FRCOG Johannes Berkhoff, PhD Phil Castle, PhD Mark Schiffman, PhD

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