GENETIC TESTS - OTHER

Primary DI

D-AlmacTP53CTAv384

Basic UDI-DI Code

B-AlmacTP53CTAv384

Reference

Almac TP53 Clinical Trial Assay (CTA) v3

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Almac Diagnostic Services Limited

The Almac TP53 CTA v3 is a qualitative in vitro diagnostic next generation sequencing (NGS) assay. It uses genomic DNA (gDNA) isolated from macrodissected formalin-fixed paraffin-embedded (FFPE) solid tumour and lymph node tissue resections and biopsies, and FFPE bone marrow biopsies and fresh-frozen (FF) bone marrow aspirate (BMA) and peripheral blood (PB). The assay identifies single nucleotide variant (SNV), small insertions and deletion events within the 5-prime untranslated region (UTR), all coding exons, part of the 3-prime UTR and all intron exon boundaries of TP53 isoform a (nm_000546.5). The assay does not differentiate between somatic or germline mutations. If the patient is considered high risk of having a germline TP53 mutation they should be referred to a formal genotype testing service. This Assay is intended for laboratory professional use only, with testing to be performed in a single laboratory site at Almac Diagnostic Services Ltd 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).