Quintiles announces comprehensive suite of PI3K biomarker assays

Quintiles today announced a comprehensive suite of biomarker assays to help biopharmaceutical companies investigate the phosphoinositide 3-kinases (PI3K) cancer survival pathway, the focus of numerous anti-cancer therapies under development. 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.

“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 biopharma companies understand this pathway, and now believe that Quintiles has the most comprehensive suite of PI3K biomarker assays available.”

Quintiles Global Central Laboratories is the only central lab with a comprehensive set of tissue analysis tools, including proprietary assays focused on the PI3K pathway, further enhancing its reputation as a leader in developing novel biomarker assays to support the clinical development of targeted therapies and other advances in personalized medicine.

"P13K is an important target for many biopharmaceutical companies and will be the subject of many discussions at the American Society of Clinical Oncology annual meeting," said Sarah Bacus, Ph.D., Senior Vice President and Chief Scientific Officer, Translational Medicine Oncology, Quintiles. "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 biopharma companies understand this pathway, and now believe that Quintiles has the most comprehensive suite of PI3K biomarker assays available."

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.

Understanding a tumor's PI3K molecular profile can support the development of multiple targeted therapies in addition to PI3K inhibitors, such as Akt inhibitors, insulin-like growth factor 1 (IGF-1R) inhibitors and epidermal growth factor receptor (ErbB) inhibitors.

Quintiles' suite of PI3K biomarker assays includes:

• PTEN IHC: a patent-pending immunohistochemistry (IHC) biomarker assay developed by Quintiles to measure the amount of phosphatase and tensin homolog (PTEN) expression in human tumors. Loss of PTEN expression or mutation of PTEN indicates an activated PI3K pathway.
• PI3K FISH: a novel Fluorescence In Situ Hybridization (FISH) test for clinical development, which Quintiles is the only global central laboratory to validate. Amplification of the PI3K gene indicates an activated PI3K pathway.
• PTEN FISH: a biomarker assay validated by Quintiles that detects whether the PTEN gene has been lost through deletion.
• PI3KCA mutations by real-time PCR: a polymerase chain reaction (PCR) analysis performed by Quintiles that can quickly profile the most common PI3KCA mutations so that patients can be screened and randomized into clinical studies rapidly, anywhere in the world. Mutation of the PI3KCA gene indicates an activated PI3K pathway.
• PI3KCA mutations by pyrosequencing: a next-generation sequence analysis technology that Quintiles is among the first in the industry to offer. This technology analyzes more than a dozen PI3KCA mutations, spanning both common and rare variants, and is ideal for exploratory studies or analyzing patient tumor samples where even rare mutations are critical to detect.

Today, at labs in the United States, Scotland and China, Quintiles develops and performs novel biomarker tests analyzing genes and proteins that affect cancer cell growth and mutation. These tests identify the genomic and proteomic changes that occur in a patient's cancer and help researchers uncover the optimum individual treatment plan. This type of personalized medicine supports therapies that are safer, more effective and increase the likelihood of positive treatment outcomes.

With a recently opened facility in Japan, Quintiles has the world's largest global network of sites certified by the College of American Pathologists, with wholly owned facilities in the U.S., Europe, South Africa, India, China and Singapore, and a tightly controlled network of affiliate laboratories in Argentina and Brazil. The network recently expanded its anatomical pathology capability in China.