Validation Resources

AMP maintains the following list of validation resources as a service to our membership and the molecular pathology community. AMP does not certify that the information contained within the linked external resource pages is complete, accurate, and/or free of commercial bias. If you identify an additional resource for inclusion or find a broken link please contact AMP. Please be advised that by clicking on an external resource link below you are leaving the AMP website.

AMP Validation Guidelines & Best Practices

• Guidelines for Validation of Next-Generation Sequencing-Based Oncology Panels: A Joint Consensus Recommendation of the Association for Molecular Pathology and College of American Pathologists
• Standards and Guidelines for the Interpretation and Reporting of Sequence Variants in Cancer: A Joint Consensus Recommendation of the Association for Molecular Pathology, American Society of Clinical Oncology, and College of American Pathologists
• Determining and Validating Germline Variant Confirmation Criteria – A Companion AMP White Paper to Recommendations for Next-Generation Sequencing Germline Variant Confirmation: A Joint Report of the Association for Molecular Pathology and National Society of Genetic Counselors – May 2023
  • Tables 2-5
• Molecular Diagnostic Assay Validation - September 2014 AMP White Paper

Next-Generation Sequencing (NGS) Validation Templates (referenced in AMP report Jennings et al., 2017)

• Performance Characteristics from Mixing Studies to Detect Different Types of Variants
• Performance Characteristics from Mixing Studies to Detect Copy Number Variations and Translocations
• Method and Template for Documenting and Describing Studies Performed in the Validation Phase

Inter-laboratory Exchange of De-identified Residual Patient Samples

• AMP Member Community for peer-to-peer requests (sAMPle Exchange)

FDA Approved/Cleared Molecular Diagnostic Tests

FDA maintains on its website lists of nucleic acid-based tests and companion diagnostic tests. Links to those web pages are below.

• Nucleic Acid Based Tests
• Companion Diagnostic Devices

If you find that the URLs have changed, or the links are broken, please notify AMP and FDA.

Cell Repositories/ Reference Materials

• American Type Culture Collection (ATCC)
• Coriell Cell Repositories
• European Collection of Authenticated Cell Cultures (ECACC)
• Genetic Testing Reference Materials Cordination Program (GeT-RM)
• German Collection of Microorganisms and Cell Cultures
• Japanese Collection of Research Bioresources
• Medical Device Innovation Consortium 
• Riken Bioresource Center

Sources of Higher Level Controls (Certified Reference Materials (CRM), Standard Reference materials (SRM))

• Institute for Reference Materials and Measurements
• National Institute of Biological Standards and Controls
• National Institute for Standards and Technology
• National Genetics Reference Laboratory Manchester
• World Health Organization- International Reference Materials

Commercial Sources of Reference Materials (alphabetical order)

This is intended as a list of commercially available stand-alone reference materials available for purchase. AMP does not support or endorse any of the companies or products listed below, but is providing this provider list as a service to the community. If we have omitted your company please contact us.

• Acrometrix
• Advanced Biotechnologies
• Anchor Molecular
• Asuragen
• Diagnostic Hybrids
• Horizon Discovery
• Invivoscribe
• LGC Standards
• Maine Molecular Quality Controls
• Molecular Controls
• QIAGEN Marseille (formerly Ipsogen)
• Qnostics
• SensID GmbH
• Seracare Life Sciences
• Vircell Microbiologists
• Zeptometrix