The Almac Group Ltd 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, unveiled last month at ASCO’s annual meeting.
Following this meeting, Almac has experienced a significant volume of enquiries from Pharma companies seeking to develop companion diagnostics strategies.
The test, once clinically available, should have a revolutionary and highly beneficial impact for 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.
Almac is currently engaged with the FDA to ensure that this assay is brought to the market in a timely manner with the appropriate regulatory approval in place.
Almac’s announcement comes ahead of this year’s BIO International Convention in San Diego (23-26 June) where the company will be unveiling their intention - alongside Arlene Foster, Northern Ireland’s Minister of Enterprise, Trade and Investment - to bring this technology to the global healthcare market to improve the management of ovarian cancer patients initially but to also transition into other cancer types.
Professor Paul Harkin, President and Managing Director of Almac’s Diagnostic Business Unit commented: “Almac is delighted to be taking a prominent position in the industry’s drive to develop novel, ground-breaking biomarkers and companion diagnostics that meet the gaps and pressing needs of the market. Indeed, we are pleased with the successful development of our AADx test and very much look forward to bringing it to the market for clinical use in ovarian cancer next year, and are confident of validating its applicability to a range of other cancer types.”
The results, already presented at ASCO 2014 in Chicago by Professor Gourley, 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 tumours fell outside of this molecular subgroup, exhibited a trend towards improved progression free survival.
The work was carried out in collaboration with the Medical Research Council in the UK. This key discovery marks the emergence of Almac as a major player in personalized medicine and in particular as a leader in the development and validation of the next generation of multiplex companion diagnostic (MCDx) tests.
Almac is confident 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 has now engaged actively with the FDA & European Regulatory Authorities and aims to obtain both FDA Approval for the US and CE-IVD marking in Europe to bring this novel AADx assay to market in 2015.
Alastair Hamilton, Chief Executive of Invest Northern Ireland, remarked: “We are very pleased that Almac is playing such a leading role in the discovery and development of novel companion diagnostic tests for cancer treatment. This is a prime example of how investment in research and development can lead to commercial and export opportunities.
He continued: “We have supported Almac over the years as it has invested in R&D, and it is great to see the company grow and get recognized on the world stage as a leading diagnostics company. I wish the company continued success as it becomes a world leader in such a global marketplace.”
Alan Armstrong, CEO, Almac Group commented: “We are delighted to be contributing our scientific expertise and know-how to the discovery and development of new biomarkers and companion diagnostics that make a real difference to healthcare and the treatment of diseases such as ovarian cancer. Indeed, we are thrilled with the success to date of our AADx assay and look forward to enabling clinicians and patients to benefit from the test through its clinical use in 2015 and beyond.”