Almac Group Announces Launch Of CLIA Validated Next Generation Sequencing Assay For P53 Mutations
P53 Considered Important Biomarker for Cancer Drug Discovery
Craigavon, UK – November 10, 2014 - Almac Group today 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.
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For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 203 6740 or e-mail: t.jervis@defacto.com.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
Almac Diagnostics is a division of Almac Group Ltd focusing on the discovery, development and delivery of novel prognostic and predictive tests. Almac Diagnostics partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.
Almac Diagnostics has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.
Visit www.almacgroup.com, e-mail info@almacgroup.com
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Craigavon, UK – November 10, 2014 - Almac Group today 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.
#END#
For media enquiries, please contact Tristan Jervis or Alex Heeley on +44 (0) 207 203 6740 or e-mail: t.jervis@defacto.com.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 30 years and now employs in excess of 3,500 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
Almac Diagnostics is a division of Almac Group Ltd focusing on the discovery, development and delivery of novel prognostic and predictive tests. Almac Diagnostics partners with the biopharmaceutical industry supporting the discovery, development and delivery of companion diagnostics.
Almac Diagnostics has a pipeline of oncology based tests in development in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.
Visit www.almacgroup.com, e-mail info@almacgroup.com
Help employers find you! Check out all the jobs and post your resume.