Johns Hopkins University owns the patent for the PI3K biomarker and has previously granted an exclusive license to Qiagen’s wholly owned subsidiary DxS, presently Qiagen Manchester.

Qiagen said that the PI3K pathway is mutated in more cancer patients than any other, playing a significant role in colorectal, gastric, breast and endometrial tumors, among others. Drugs that inhibit PI3K are a significant focus of current cancer drug development.

Roche has an ongoing program to develop a real-time PCR assay that detects mutations in the PI3K oncogene. The assay will run on Roche’s cobas 4800 System. Roche intends to make the PI3K PCR assay available to internal and external pharmaceutical partners for use in clinical drug trials.

Paul Brown, president and CEO of Roche Molecular Diagnostics, said: “There is abundant clinical evidence that the PI3K biomarker will play a significant role in the future of oncology treatment. Diagnostic assays that detect mutations in PI3K will be an essential component of cancer drug development and personalised healthcare.

“Given the demonstrated predictive value of these biomarkers, developing assays that identify clinically relevant mutations is an area of high priority for Roche. By applying our vast, global experience in both cancer drug development and molecular diagnostics, we believe we can quickly generate new assays that will provide value to both drug developers and oncology medical professionals.”