TP53 Clinical Trial Assay

Almac has developed a CLIA-compliant analytically validated Next Generation sequencing assay for the TP53 tumour 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 enrolment.

This TP53 assay has been analytically validated for FFPE tissue using a dual amplicon workflow which can effectively determine true variants from FFPE artefacts. The TP53 Assay is designed and developed in accordance with ISO13485:2016 Quality Management System. This assay confidently confirms both Mutation Detected and Mutation Not-Detected status thanks to stringent individual base QC which are built into the QC software which 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

  • Dual amplicon workflow and individual base QC ensures high-confidence Mutation Detected and Mutation Not Detected status from FFPE samples
  • Rapid turnaround time
  • Access to raw data
  • Powerful reporting and interpretation services

Future development

  • Almac are currently performing RUO level validation of the assay to permit retrospective testing of peripheral blood and bone marrow aspirate samples. If required, Almac can extended this validation to make the assay CLIA compliant and suitable for prospective clinical testing.

Fact Sheet

TP53 Clinical Trial Assay

Download Fact Sheet

Performance Specification

TP53 Clinical Trial Assay

Download Performance Specification

*By submitting your information you acknowledge that you have read the privacy statement and you consent to our processing the data in accordance with that privacy statement. We may, from time to time, send you material relevant to your interests. If you change your mind at any time about wishing to receive material from us, you can send an email to info@almacgroup.com. Every email we send you will also include an unsubscribe link so you can unsubscribe from our marketing list.