NEW YORK (GenomeWeb) – Qiagen said today that it has initiated a clinical development program with Novartis for a molecular companion diagnostic to guide the use of a Novartis investigational PI3K inhibitor in certain breast cancer patients.
Specifically, the proposed CDx would guide use of Novartis' BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women with PIK3CA-mutated, hormone receptor-positive, EGFR receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer.
The Novartis drug candidate is in late-stage development, and Qiagen expects to provide its CDx to clinical laboratory partners who will then be ready to immediately offer it upon potential regulatory approvals.
Qiagen said the CDx will cover DNA extraction, detection of clinically relevant mutations, and final reporting. The test will be clinically validated using both formalin-fixed paraffin-embedded tissue and plasma samples, and will run on Qiagen's Rotor-Gene Q instrument, a component of the QiaSymphony family of automated molecular diagnostic platforms.
Currently, there are no US Food and Drug Administration-approved therapies targeting PIK3CA mutations in HR+/HER2- advanced breast cancer.
"Under our master collaboration agreement with Novartis, we are fast-tracking the development of a companion diagnostic for BYL719 to help close this gap," Jonathan Arnold, vice president and head of oncology and precision diagnostics for Qiagen, said in a statement. The new test will provide "clinically relevant information to aid physicians in choosing which patients to treat with BYL719" and will be "launch-ready for patient testing on 'day one' if approved by the FDA, in collaboration with a leading molecular pathology lab," he added.