GENETIC TESTS - OTHER

Primary DI

D-TP53CTAv3ADX170836V

Basic UDI-DI Code

B-TP53CTAv3ADX170836V

Reference

Almac TP53 CTA v3 ADX17083

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

No Longer On The Market

Manufacturer

Almac Diagnostic Services Limited

The Almac TP53 CTA v3 ADX17083 is a qualitative in vitro diagnostic next generation sequencing (NGS) clinical trial assay (CTA). It uses genomic DNA (gDNA) isolated from formalin-fixed paraffin embedded (FFPE) samples from solid tumour and lymph node resections and biopsies, to identify non-synonymous single nucleotide variants (SNVs), small insertions and small deletions within the coding sequence of TP53 isoform a (CCDS11118.1; nm_000546.5). The assay is intended to be used to determine the TP53 status of subjects participating in clinical trials evaluating the clinical safety and efficacy of BI 907828. The assay does not differentiate between somatic or germline mutations and therefore, if the patient is considered high risk of having a germline TP53 mutation they should be referred to a formal genetic testing service. This Assay is intended for laboratory professional use only, with testing to be performed at Almac Diagnostic Services Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) accredited laboratories located at 19 Seagoe Industrial Estate, BT63 5QD, UK, using Illumina MiSeq systems

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).