TP53 Clinical Trial Assay

Almac has developed a CLIA-compliant analytically validated Next Generation sequencing assay for the TP53 tumor suppressor gene, which is linked to many cancers. This clinical trial assay (CTA) is intended to detect germline and somatic DNA aberrations enabling determination of molecular eligibility to facilitate clinical trial enrollmenT.

This TP53 assay has been analytically validated for Fixed Formalin Paraffin Embedded (FFPE) solid tumor, lymph node & bone marrow samples. In addition, it utilizes a dual amplicon workflow which can effectively determine true variants from FFPE artifacts. 

The TP53 Assay is designed and developed in accordance with an ISO13485:2016 Quality Management System. This assay confidently confirms both Mutation Detected and Mutation Not-Detected status thanks to stringent individual base QC which is built into the QC software and has been developed in compliance with the IEC 62304 and ISO14971. Almac’s bioinformatics expertise can develop bespoke data filtering, annotation and reporting software on a per-project basis.

Key benefits

  • Detection of SNVs, small insertion and deletion events
  • Comprehensive coverage of the full coding sequence
  • Dual amplicon workflow and individual base QC ensures high-confidence Mutation Detected & Mutation Not Detected status from FFPE samples
  • Rapid turnaround time
  • Access to raw data
  • Powerful reporting and interpretation services

Future development

Almac is currently developing an RUO TP53 NGS assay suitable for use with ctDNA. For interested Biopharma clients, if required, Almac can extend this validation to make the assay CLIA compliant and suitable for prospective clinical testing.

Fact Sheet

TP53 Clinical Trial Assay

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Performance Specification

TP53 Clinical Trial Assay

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