CRAIGAVON, NORTHERN IRELAND, 21 Jan 2014 – Almac’s Diagnostics business unit today announced the publication of its breast cancer chemotherapy response assay in the Journal of the National Cancer Institute (JNCI).
The article entitled “Identification and Validation of an Anthracycline/Cyclophosphamide– Based Chemotherapy Response Assay in Breast Cancer” led by Almac’s Medical Director, Professor Richard Kennedy gives detail on the development and initial validation of a predictive gene signature for chemotherapy response in breast cancer.
Breast Cancer is the world’s most common cancer among women with one in eight diagnosed in their lifetime. Although modern chemotherapy reduces the risk of recurrence for some patients, not everyone benefits. At present there is no means of identifying those patients who will and will not respond to first line therapy. Almac’s objective in the development of this assay was to provide a means of identifying those breast cancer patients more likely to respond to standard of care chemotherapy treatment.
The assay was developed by Almac in collaboration with Queens University, Belfast and the Mayo Clinic, Rochester, USA. Almac carried out microarray analysis of patient samples and identified a molecular subgroup with a deficiency in DNA damage repair, termed DDRD for DNA Damage Repair Deficient. Almac then developed a 44 gene classifier capable of prospectively identifying this molecular group in patient tumour samples.
The DDRD signature was then initially validated in a neo-adjuvant breast cancer cohort. In the neo-adjuvant setting the assay predicted complete pathologic response with an odds ratio of 3.96, meaning those patients that were DDRD positive were almost four times more likely to respond to treatment compared to patients that were DDRD negative. In the adjuvant setting, a DDRD positive result predicted 5 year relapse free survival with a Hazard Ratio 0.37 compared with test negative patients.
“The publication of this data represents a significant milestone for Almac as we transition this assay into the clinic. The publication of these results combined with our recent out-licensing of the assay to Genomic Health for use in breast cancer patients, highlights the quality of the science being carried out here in Almac” said Professor Paul Harkin, President and Managing Director of Almac’s Diagnostics business unit.
The test has been developed and validated exclusively using formalin fixed paraffin embedded (FFPE) tissue using Almac’s own proprietary Breast Cancer DSA®.
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 3,300 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with US operations based in Pennsylvania, North Carolina and California.
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 media@almacgroup.com
Contact: De Facto Communications
Tristan Jervis
T.Jervis@Defacto.com
T: 00 44 207 861 3019
M: 00 44 771 363 8396
Contact: Almac
Austin Tanney
austin.tanney@almacgroup.com
T: 00 44 2838 337575
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