PIK3CA-11 mutations 12.5% AF cfDNA
PIK3CA Mutations: Key Insights for Detection and Treatment PIK3CA mutations are critical in hormone receptor-positive, HER2-negative breast cancer, occurring in about 40% of cases, mainly in Exons 9 and 20. These mutations are also common in endometrial, colon, and other cancers. Detecting these mutations is vital for personalized treatment. The Qiagen therascreen® PIK3CA RGQ PCR Kit, FDA and CE-IVD approved, identifies mutations in tumor tissue and circulating tumor DNA (cfDNA) with a sensitivity of 12.5% for PIK3CA-11 mutations. Alpelisib (PIQRAY®) has also been approved for patients with PIK3CA-mutated advanced or metastatic breast cancer.
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This kit in detail
- Personalized Treatment Options
- Targeted Therapy Selection
- Companion Diagnostic Approval
- Comprehensive Testing
PIK3CA mutations play a significant role in various cancers, particularly in hormone receptor-positive, HER2-negative breast cancer, where they occur in about 40% of cases, mainly within Exons 9 and 20. These mutations are also prevalent in endometrial, colon, urinary tract, cervical, and large intestine cancers.
Importance of Detection
Detecting PIK3CA mutations is crucial for personalizing treatment plans. The Qiagen therascreen® PIK3CA RGQ PCR Kit, approved by the FDA and CE-IVD, identifies these mutations in tumor tissue and circulating tumor DNA (cfDNA) with a sensitivity of 12.5% for PIK3CA-11 mutations.
The FDA has approved alpelisib (PIQRAY®) in combination with fulvestrant for postmenopausal women and men with PIK3CA-mutated advanced or metastatic breast cancer. The therascreen® PIK3CA RGQ PCR Kit serves as a companion diagnostic test, ensuring the selection of appropriate candidates for targeted therapies.
Reference Set of Control
The Reference Set of Control designed for the therascreen® PIK3CA RGQ PCR Kit aligns with the assay protocol, enhancing test accuracy and patient outcomes.
Conclusion
PIK3CA mutations are critical in guiding treatment decisions for hormone receptor-positive, HER2-negative breast cancer. Utilizing advanced diagnostic tools like the Qiagen therascreen® PIK3CA RGQ PCR Kit empowers healthcare providers to offer personalized care and improve patient outcomes. Discussing PIK3CA testing with a healthcare provider can significantly impact treatment strategies for those diagnosed with breast cancer.
| 1 | PIK3CA-C420R + PIK3CA-E545A |
| 2 | PIK3CA-Q546R + PIK3CA-E542K |
| 3 | PIK3CA-H1047L + PIK3CA-E545D |
| 4 | PIK3CA-H1047R + PIK3CA-E545G |
| 5 | PIK3CA-H1047Y + PIK3CA-E545K |
| 6 | PIK3CA-Q546E |
| 7 | incl. Wildtype (Ashkenazim son cfDNA Cat. No.: SID-000003 |
Datasheets and regulatory documentation
Everything your quality team needs for evaluation and procurement.
Frequently paired with this kit
Other assays and instruments lab teams add alongside the PIK3CA-11 mutations 12.5% AF cfDNA.
Plasma 2x (human-tech) DNA free dilution buffer
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