Understanding the PI3K pathway is essential in developing new medicines to inhibit or block this pathway, thereby cutting off a metabolic function needed for certain cancers to survive.

Quintiles’ suite of PI3K assays can help researchers determine if the PI3K pathway has been ‘activated’ in a particular cancer patient, indicating that an investigational therapy targeting the PI3K pathway may be appropriate for that patient.

Quintiles’ PI3K biomarker solutions are also useful in exploratory studies to retrospectively determine a tumor’s PI3K molecular profile.

Quintiles’ suite of PI3K biomarker assays includes PTEN IHC – a patent-pending immunohistochemistry (IHC) biomarker assay, PI3K FISH – a novel Fluorescence In Situ Hybridization (FISH) test for clinical development, PTEN FISH – a biomarker assay to detect whether the PTEN gene has been lost through deletion, PI3KCA mutations by real-time PCR – a polymerase chain reaction (PCR) analysis and PI3KCA mutations by pyrosequencing – a next-generation sequence analysis technology.

Quintiles Global Central Laboratories claimed that it is the only central lab with a comprehensive set of tissue analysis tools, including proprietary assays focused on the PI3K pathway, to develop novel biomarker assays to support the clinical development of targeted therapies and other advances in personalized medicine.

Sarah Bacus, SVP and chief scientific officer of translational medicine oncology at Quintiles, said: “P13K is an important target for many bio pharmaceutical companies and will be the subject of many discussions at the American Society of Clinical Oncology annual meeting.

“Understanding this pathway will help support the clinical development of targeted therapies to this pathway and advances in personalized medicine. We anticipated the need for a toolset to help bio pharma companies understand this pathway, and now believe that Quintiles has the most comprehensive suite of PI3K biomarker assays available.”