The third major difference is the lack of any FDA approvals for the 21 gene assay as compared to the 5 FDA approvals for the 70 gene assay. Table 10 Comparison of the 70 gene assay versus 21 gene assay:- Feature 70 gene assay 21 gene assay Year First Published 2002 2002 Number of genes tested 70 16 (5 reference genes) Gene pool selected from 25,000 250 Nature of gene selection Scientific analysis to derive Committee selection process 70 key genes from whole of chosen genes genome Test type mRNA microarray RT PCR FDA approvals Five (plus one under Nil consideration) Tertiary Low, Intermediate Results Binary Low or High Risk – – & High Clinical utility Helpful binary test result for Unhelpful intermediate risk binary choice regarding category for binary choice chemotherapy regarding chemotherapy Validation Binary result validated Recurrence score not validated by FDA by FDA Cost effectiveness More cost effective Less cost effective – (primarily due to intermediate (no intermediate result) result) Patient specimen data Untreated patients 5 years of Tamoxifen
The third major difference is the lack of any FDA approvals for the 21 gene assay as compared to the 5 FDA approvals for the 70 gene assay. Table 10 Comparison of the 70 gene assay versus 21 gene assay:- Feature 70 gene assay 21 gene assay Year First Published 2002 2002 Number of genes tested 70 16 (5 reference genes) Gene pool selected from 25,000 250 Nature of gene selection Scientific analysis to derive 70 key genes from whole genome Committee selection process of chosen genes Test type mRNA microarray RT PCR FDA approvals Five (plus one under consideration) Nil Results Binary – Low or High Risk Tertiary – Low, Intermediate & High Clinical utility Helpful binary test result for binary choice regarding chemotherapy Unhelpful intermediate risk category for binary choice regarding chemotherapy Validation Binary result validated by FDA Recurrence score not validated by FDA Cost effectiveness More cost effective (no intermediate result) Less cost effective – (primarily due to intermediate result) Patient specimen data Untreated patients 5 years of Tamoxifen
1376-ApplicantConsultationProtocol-accessible.docx