AV - Almac TP53 Next Generation Sequencing CTA for BI
Research type
Research Study
Full title
Establishment of Performance Specifications and Quality Control Procedures of the Almac TP53 Next Generation Sequencing Clinical Trial Assay for Boehringer Ingelheim
IRAS ID
234895
Contact name
Richard Kennedy
Contact email
Sponsor organisation
Almac Diagnostics Ltd
Duration of Study in the UK
0 years, 4 months, 16 days
Research summary
The purpose of this study - Almac aim to develop and analytically validate Almac’s Tumour protein 53 (TP53) Next generation Sequencing (NGS) assay and Abbott Molecular’s mouse double minute 2 (MDM2) Fluorescent in situ hybridisation (FISH) assay as clinical trial assays (CTAs) for use in planned trials in patients with non-small cell lung carcinoma (NSCLC), bladder cancer, glioblastoma, sarcoma and solid tumors with brain metastases including lymph node tissue. Almac have developed and validated a NGS test utilising the commercially available TruSight Tumour 26 (TST26) reagents (Illumina) in conjunction with a set of TP53-specific oligonucleotides. Almac are currently transitioning their TP53 CTA to a new chemistry. The validation of the Almac TP53 CTA using Illumina’s new chemistry will incorporate all requirements necessary for its implementation in planned retrospective and prospective clinical trials. This updated test will be referred to as the Almac TP53 CTA Version 2 (v2).
REC name
London - Dulwich Research Ethics Committee
REC reference
17/LO/1658
Date of REC Opinion
22 Sep 2017
REC opinion
Favourable Opinion