Almac Group announced that it has launched a CLIA validated next generation sequencing test for P53 mutations. The P53 test can be run on formalin fixed paraffin embedded (FFPE) samples enabling patient stratification for early phase trial enrichment studies and potential companion diagnostic development. It has been developed using the Illumina technology.
Almac has extensive expertise in developing multiplex diagnostics and have many multiplex RNA and DNA assays running in early phase trial enrichment studies in their UK based CLIA laboratory. Several trials have already been run in which P53 was important for stratification and in order to meet this customer need Almac developed the comprehensive P53 sequencing assay.
The test covers all coding regions and upstream regulatory regions of P53 and provides detail on specified mutations as well as a significant amount of sequence data that allows the potential discovery of other clinically relevant mutations. The way the test has been designed allows CLIA reporting to be carried out on each client’s specific mutations of interest using annotation and filtering software developed by Almac for the CLIA test. In addition to the variants of interest, all the sequence data can also be released for discovery studies.
The test will be run in in Almac’s CLIA certified and CAP accredited clinical testing laboratory and is available now for general use. The test has been specifically developed to support early phase trial enrichment studies and can be run with a one week turnaround time where required.
“We have developed and launched this test as a response to an obvious customer demand. P53 is an important oncogene that is linked to many cancers and there are a significant number of new therapies in the pharma pipeline for which P53 is being used as a biomarker. Next generation sequencing was an ideal approach for an assay of this complexity and the Illumina technology is an excellent platform on which to deliver such a test,” said Professor Paul Harkin, President of Almac’s Diagnostic business unit.