Almac Group has launched a CLIA validated next-gen sequencing test for P53 mutations, a biomarker for cancer drug discovery. Developed using the Illumina technology, 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. 
  
The test covers all coding regions and upstream regulatory regions of P53 and provides detail on specified mutations as well as sequence data that allows the potential discovery of other clinically relevant mutations. The test was designed to allow 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. Additionally, all the sequence data can be released for discovery studies. 
 
The test will be run in Almac’s CLIA certified and CAP accredited clinical testing lab and is available now for general use.
 
“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.