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Almac validates novel test for ovarian cancer patients


2 June, 2014  
Almac Group Ltd’s Diagnostics Business Unit has announced the validated results of the ALM AADx assay, a gene expression test that identifies a subgroup of high grade serous ovarian cancer (HGSOC) patients that have a good prognosis following standard of care chemotherapy.
 
Significantly this good prognosis subgroup exhibited worse progression free and overall survival following the addition of bevacizumab within the ICON7 translational dataset. Patients whose tumours fell outside of this molecular subgroup exhibited a trend towards improved progression free survival
 
The molecular subgroup identified by this test is defined by absence of angiogenesis and represents 40% of the HGSOC population. The molecular subgroup was identified by Almac in collaboration with Professor Charlie Gourley from the University of Edinburgh and was initially reported at ASCO 2011. The current work represents an independent validation of the assay and was carried out in collaboration with the Medical Research Council in the UK.
 
Unsupervised hierarchical clustering by Almac found three molecular subgroups within HGSOC; one with angiogenic gene inactivation and immune gene upregulation (‘termed the immune’ subgroup ) with better overall survival rates; and two with angiogenic gene upregulation and a corresponding worse overall survival rate following standard of care first line chemotherapy.
 
These latest validation results were presented today at the 2014 ASCO Annual Meeting in Chicago by Professor Gourley
 
Almac developed a 63 gene test that can prospectively identify the good prognosis angiogenesis inactive subgroup and independently validated the test within the ICON7 translational data set. 
 
Almac is now seeking to perform additional validation studies of the test in HGSOC as well as in other cancer types. Almac believes that the test will also work for other anti-angiogenic compounds that function in a similar manner as well as for other diseases and has now engaged with the FDA & European Regulatory Authorities to bring this novel assay to market in 2015.
 
Prof Richard Kennedy, Almac & Queen’s University Belfast, stated, “This assay may help clinicians discuss the likely benefit from standard carboplatin and paclitaxel based chemotherapy with their patients and could inform discussions on other potential approaches to treatment for those with a predicted worse outcome
 
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 operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).
Almac’s diagnostics business unit focuses on the discovery, development and delivery of novel prognostic and predictive tests. Partnering with the biopharmaceutical industry, Almac support the discovery, development and delivery of companion diagnostics in addition to developing their own pipeline of oncology based tests in therapeutic areas including breast, colon, ovarian, prostate and lung cancer.
For more information on Almac’s advances in Multiplex Companion Diagnostics (MCDx) visit: