Almac and Lilly UK have entered into a partnership to develop a companion diagnostic for ALIMTA, with cisplatin, as a combination therapy for non-squamous non-small cell lung cancer.

The study focuses on evaluating Thymidylate Synthase (TS) as a predictive marker of response to Alimta in combination with cisplatin. A number of parallel exploratory analyses will be performed as alternative strategies to identify further potentially novel predictive biomarkers of response to the combination therapy. These include global gene expression profiling from FFPE tumour samples using the Almac Diagnostics Lung Cancer DSA™ research tool.

Paul Harkin, president of Almac Diagnostics explains;

     "Almac is focussed on enabling personalised medicine. Our core
      expertise is in the discovery and validation of both prognostic
      and predictive biomarkers. We have a specific expertise in the
      development of biomarkers from FFPE tissue and are very happy to
      announce this partnership with Lilly."

The project will involve a multi-centre, single arm Phase II study that will recruit patients diagnosed at stage IIIB/IV. Almac’s technical team will perform global gene expression profiling, microRNA profiling, SNP genotyping, qPCR validation as well as data analysis and project management of the study. The final endpoint will be the development of a companion diagnostic test that will select patients likely to benefit from treatment with ALIMTA.

Source: Almac Diagnsotics