Roche obtained a worldwide, co-exclusive license to the PI3K biomarker from Qiagen. The firm will leverage the biomarker in the development of real-time and endpoint PCR diagnostic assays. Qiagen’s wholly owned U.K.-based subisidary, DxS, negotiated its exclusive global license to the PI3K biomarker from Johns Hopkins University in February.
Roche says work is already ongoing to develop a real-time PCR assay for PI3K mutations for use on its cobas®4800 system. The firm plans to make the assay available for its in-house drug development programs and to external pharmaceutical partners for use in clinical trials.
DxS already has a PI3K mutation test kit available for research use in Australia. The kit detects four PI3K mutations in exons 9 and 20. It combines the firm’s ARMS® (Amplification Refractory Mutation System) technology with the Scorpions® real-time PCR platform.
Roche believes ample published research supports the utility of PI3K as a marker to predict an individual patient’s response to cancer therapy. “There is abundant clinical evidence that the PI3K biomarker will play a significant role in the future of oncology treatment,” states Paul Brown, president and CEO at Roche Molecular Diagnostics. “Diagnostic assays that detect mutations in PI3K will be an essential component of cancer drug development and personalized healthcare."
Roche’s oncology therapeutics pipeline includes a small molecule PI3K inhibitor PG7422, which is undergoing Phase I trials for the treatment of solid cancers. Roche’s Genentech is also developing PI3K inhibitors as part of its oncology pipeline. GDC-0941 is being evaluated in Phase I trials against metastatic breast cancer and metastatic non-small-cell lung cancer in combination with targeted drugs including Avastin® and Tarceva®. A dual PI3K/mTOR dual inhbitor, GDC-0980 is in Phase I development as a potential treatment for solid tumors and non-Hodgkin’s lymphoma.