Analytical validation - performance characteristics - Almac TST-170
Research type
Research Study
Full title
Analytical validation of the performance characteristics of the Almac TST-170 IUO assay
IRAS ID
232478
Contact name
Richard Kennedy
Contact email
Sponsor organisation
Almac Diagnostics Ltd
Duration of Study in the UK
0 years, 4 months, 26 days
Research summary
The objective of this research study is to analytically validate the performance characteristics of the Almac TST-170 IUO assay, a diagnostic test that has been designed to evaluate a variety of alterations within 170 genes which are associated with tumour development. The Almac TST-170 IUO assay is a qualitative assay intended to detect genomic aberrations in formalin fixed paraffin embedded solid tumor tissue. The assay detects aberrations from both DNA and RNA to facilitate patient selection based on the presence or absence of molecular markers in a trial agnostic setting (please note that separate ethics application(s) will be made for any future clinical trials). The purpose of this study is to analytically validate the performance characteristics of the Almac TST-170 IUO assay to ensure that the assay it is fit for intended use. There is an increasing emphasis on the evaluation of multiple genetic alterations which are known to drive tumor development. The adoption of multigene panels which evaluate multiple genetic alterations into clinical diagnostic laboratories allows for multiple tests to be carried out using a single assay. These tests provide clinicians with the opportunity to evaluate multiple genes in patients with known or suspected malignancies, offering the potential for patients to receive treatment which is targeted to their specific malignancy.
The research will ensure that the Almac TST-170 IUO assay (a next generation sequencing test for 170 genes) is analytically valid i.e. provides robust results. Validation will be performed across a representative set of the 170 genes and include both the bench work in the laboratory and also the analysis of the data.REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
17/LO/1369
Date of REC Opinion
4 Aug 2017
REC opinion
Favourable Opinion