Technical Assessment Forms

Published 08/31/2022

Download Technical Assessment Forms (PDF)

TA Form Required Test

GEN-CQ-003
Technical Assessment Submission Checklist

All tests submitting a Technical Assessment

GEN-PF-001
Technical Assessment (TA) Summary Form

Tests with results that are either novel or proprietary technology and/or algorithms.

Tests that require an evaluation of clinical utility or clinical validity that is not already established in existing policies or standards of care.

NGS-PF-004
Analytical Validity, Clinical Validation Summary Worksheet, NGS Solid Tumors

NGS “Targeted” Panel

NGS “Comprehensive Genomic Profile” – Solid Tumor

NGS-PF-005
Analytical Validity, Clinical Validation Summary Worksheet, Myeloid Malignancies

NGS “Targeted" Panel

NGS “Comprehensive Genomic Profile” – Hematopoietic malignancy

NGS-PF-006
Analytical Validity, Clinical Validation Summary Worksheet, NGS in Inherited Cancer Testing

UPDATED as of August 31, 2022

Inherited Cancer Testing

NGS-PF-002
Analytical Validity – Performance Specifications for Comprehensive Genomic Profiling Checklist, Somatic and Germline
 

NGS “Comprehensive Genomic Profile” – Solid Tumor

NGS “Comprehensive Genomic Profile” – Hematopoietic malignancy

Whole Exome Sequencing

Whole Genome Sequencing

MRD-PF-016
 Analytical Validity, Clinical Validity Summary Worksheet, MRD

Minimial Residual Disease (MRD) Testing

MRS-PF-020
 Analytical Validity, Clinical Validity Summary Worksheet, MRS

Molecular Testing for Risk Stratification (MRS)

Example: Biomakers

MID-PF-019
Analytical Validity, Clinical Validation Summary Worksheet, Syndromic Infectious Disease Panels

Molecular Testing for Syndromic Infectious Disease (MID)

PGX-PF-007
Pharmacogenomics Submission Form

Pharmacogenomics (PGx) tests

ALLO-CQ-003
Technical Assessment Submission Checklist and Questionnaire for Solid Organ Allograft Rejection

Molecular Testing for Solid Organ Allograft Rejection

ALLO-PF-009
Allograft Rejection Performance

Molecular Testing for Solid Organ Allograft Rejection

GEN-PF-010
Gapfill Worksheet

Required for tests that must be priced by Palmetto GBA