Qiagen NV, of Venlo, the Netherlands, said a clinical development program is underway with Novartis AG, of Basel, Switzerland, to develop a companion diagnostic to guide the use of BYL-719 (alpelisib) in combination with fulvestrant to treat men and postmenopausal women with PIK3CA-mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer. Qiagen expects the test to be available for clinical labs upon potential regulatory approval of BYL-719, which has completed the phase III SOLAR trial in individuals with HR+/HER2- advanced breast cancer.