Almac Advances Cancer Biomarker for Companion Diagnostics

Almac has announced plans to make its ALM AADx assay, a gene-expression test developed by its Diagnostics Business Unit, available for clinical use in 2015. Further validation of the test in ovarian cancer is on track for completion by the end of this year following the first validated results for a patient cohort, released in May at the American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago. The assay can function with companion diagnostics.  

The test, once clinically available, would serve ovarian cancer patients, demonstrating likely treatment outcomes, which will enable personalized care plans and provide clinicians with better data to prescribe appropriate drug regimens. In some patients, the use of certain drugs may produce adverse outcomes, and this test will help to better identify these cohorts and potentially improve life expectancy. The results, already presented at ASCO, identified a molecular subgroup of high grade serous ovarian cancer (HGSOC) patients – defined by the absence of angiogenesis and representing 40% of the HGSOC population – that showed good prognosis following standard of care chemotherapy. However, these patients also exhibited a worse progression free and overall survival following the addition of bevacizumab within the ICON7 study translational dataset. By contrast, patients whose tumors fell outside of this molecular subgroup, exhibited a trend toward improved progression free survival. The work was carried out in collaboration with the Medical Research Council in the UK.

Almac says that the test will work both for other anti-angiogenic compounds, functioning in a similar manner, as well as for other cancer types. The company is actively engaged with the US Food and Drug Administration and European regulatory authorities and aims to obtain both FDA approval for the US and CE-IVD marking in Europe to bring the AADx assay to market in 2015.

Source: Almac

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