Qiagen Korea said on Monday that its companion diagnostic (CDx) -- screening PIK3CA gene in patients suitable for prescribing Novartis’  breast cancer treatment Piqray (ingredient: alpelisib) -- started receiving reibmursement from July 1.

The insurance coverage will benefit postmenopausal patients with advanced breast cancer who are hormone receptor (HR+) positive and human epithelial growth factor receptor 2 (HER2-) negative. 

Tissue specimens will be primarily used for the diagnostic test but the use of plasma specimens is authorized when tissue samples are not available. For example, tissue samples are difficult to obtain from cervical and upper thoracic spine lesions, pelvic bones, peritoneum, pleura, and mediastinal lymph nodes.

Early diagnosis at a reasonable price is expected to help improve the survival time of patients with advanced breast cancer, Qiagen Korea said.

The PIK3CA gene mutation is estimated to be present in about 40 percent of advanced breast cancer patients and is also found in endometrial and ovarian cancers in addition to breast cancer.

The PIK3CA CDx genetic test uses DNA extracted from breast tumor tissue or plasma to qualitatively detect 11 genetic variants within exon 7, exon 9, and exon 20 by real-time polymerase chain reaction (PCR). The qualitative test will be performed on the Rotor-Gene Q MDx medical device, Qiagen's automated solution.

"With the reimbursement of the PIK3CA Kit, patients with advanced breast cancer will be able to diagnose their disease and start treatment earlier and at an affordable price," said Qiagen Korea CEO William Lin. "We will continue to optimize diagnostic solutions to provide personalized healthcare solutions.”