Almac Announces Launch of CLIA Validated Next Generation Sequencing Assay
News Nov 13, 2014
Almac Group has 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 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.
Advanced Prostate Cancer: EMA Approves Abiraterone Combined With Hormone Therapy as First-line TreatmentNews
The prostate cancer drug abiraterone has been approved by the European Medicines Agency in combination with standard hormone therapy for use as a first-line treatment for advanced prostate cancer.READ MORE
New Simple Test Could Help Cystic Fibrosis Patients Find Best TreatmentNews
In a significant step toward personalized medicine for cystic fibrosis, a minimally-invasive technique shows promise as a fast, inexpensive indicator to help more patients access new treatments.READ MORE
Cancer Cells Prevent Immune Cells from Producing Cancer Killing ChemicalsNews
Researchers have identified a substance released by pancreatic cancer cells that protects them from attack by immune cells called macrophagesREAD MORE
Comments | 0 ADD COMMENT
3rd Annual NGS Data Analysis and Informatics Conference
Feb 08 - Feb 09, 2018
3rd Annual Genome Editing & Engineering Conference
Feb 08 - Feb 09, 2018