Diagnostics for the early detection and prevention of colon cancer
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1 Diagnostics for the early detection and prevention of colon cancer Cologuard Test Crosswalk Proposal July 14 th, 2014
2 Colorectal cancer: the second-leading U.S. cancer killer Annual U.S. cancer mortality 159, ,830 new U.S. cases Colorectal 40,430 39,590 29,480 50,310 50,310 U.S. deaths 4,020 14,270 Cervix Ovary Prostate Pancreas Breast Lung 1 Source: ACS Cancer Facts & Figures 2014; all figures annual
3 Major opportunity to improve colorectal cancer screening The most preventable, yet least prevented cancer. Journal of the National Cancer Institute 2 Source: Itzkowitz SH, J Natl Cancer Inst. (2009)
4 Detection and removal of polyps prevents cancer years 2 Pre-cancerous polyp Stages of colon cancer 3 Source: 1) Winawer et al., Gastro (1997) 2) Zauber et al., N Engl J Med (2012)
5 Cologuard TM Overview Cologuard is a non-invasive colorectal cancer screening test developed in concert with the Mayo Clinic Stool is analyzed for 11 biomarkers and produces a single, positive/negative result based on an optimized logarithmic algorithm that weights the individual scores Performance established in 10,000 patient clinical study published in the New England Journal of Medicine 1 GXXXX Colorectal cancer screening; stool-based DNA and fecal occult hemoglobin (e.g., KRAS, NDRG4 and BMP3) For Investigational Use Only. The performance characteristics of this product have not been established. 4 Source: 1) Imperiale, et al., N Engl J Med (2014)
6 Cologuard TM Components for Crosswalking G-Code GXXXX Collection Kit + 2 DNA Methylation Markers NDRG4 and BMP3 + 7 DNA Mutation Markers All KRAS mutations Codons 12 & 13 + DNA Normalization Marker Beta Actin + Fecal Hemoglobin Marker FIT + Algorithm = Cologuard TM 5
7 Recommended CPT Codes for Crosswalk Cologuard TM Component Collection Kit 2 DNA Methylation Markers (NDRG4 and BMP3) 7 DNA Mutation Markers (All KRAS) DNA Normalization Markers (Beta Actin) Fecal Hemoglobin (FIT) Algorithm CPT Code for Crosswalk N/A PML/RARalpha, (t(15;17)), (promyelocytic leukemia/retinoic acid receptor alpha) (eg, promyelocytic leukemia) translocation analysis; common breakpoints (eg, intron 3 and intron 6), qualitative or quantitative KRAS (v-ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, variants in codons 12 and 13 N/A Blood, occult, by fecal hemoglobin determination by immunoassay, qualitative, feces, 1-3 simultaneous determinations N/A 6
8 Comparison of Cologuard TM Methylation (NDRG4 & BMP3) and Tier 1 Code Cologuard TM Methylation Sample for DNA Purify specific target DNA from sample Blood or bone marrow sample Purify mrna from sample Bisulfite convert DNA for methylation analysis Purify converted DNA Perform 3-color Quantitative QuARTS reaction with targets (BMP3, NDRG4 and ACTB) and calibrators Calculate target concentrations (BMP3, NDRG4 and ACTB) Combine result with other biomarkers and report result Perform 2-color Quantitative RT- PCR with target and calibrators (control mrna) Calculate target concentration (PML/RAR translocation) Report result 7
9 Proposed crosswalk captures the individual components of the Cologuard test Cologuard TM Component Crosswalk Rationale Proposed Payment (CLFS 2014 NLA) Collection Kit N/A Included N/A 2 DNA Methylation Markers (NDRG4 and BMP3) 7 DNA Mutation Markers (All KRAS) DNA Normalization Markers (Beta Actin) Fecal Hemoglobin (FIT) ML/RARalpha KRAS N/A FIT Similar based on steps involved in methylation Code directly describes steps involved Quality assurance marker not separately paid by CMS Code directly describes steps involved $ $ N/A $21.70 Algorithm N/A Included N/A Total $
10 APPENDIX 9
11 Detailed Description of Cologuard Assay Collect sample for DNA Collect sample for hemoglobin Purify Specific target DNA from sample Bisulfite convert DNA for methylation analysis Wash DNA for KRAS Purify converted DNA Perform 3-color Quantitative QuARTS reaction with targets (BMP3, NDRG4 and ACTB) and calibrators Calculate target concentrations (BMP3, NDRG4 and ACTB) Purify DNA Perform 3-color Quantitative reaction with targets (7 KRAS mutations and ACTB) and calibrators Calculate target concentrations (KRAS and ACTB) Perform Quantitative ELISA assay for Hb with calibrator Calculate Hb concentration Calculate Cologuard score and report result Positive or Negative 10
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