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TEST:
AYVAKIT® CDx test

Type:
Other Approval
Related tests:

Details

Evidence
The AYVAKIT® CDx test kit is based on a real-time PCR fluorescent probe, specific primers, Taqman probes, and highly specific Taq enzymes to detect gene mutations. This enables the test kit to detect mutations with higher specificity and sensitivity in DNA samples. As a proprietary companion diagnostic for AYVAKIT®, the CDx kit can be used to effectively detect PDGFRA D842V gene mutation in GIST patients, providing accurate molecular diagnosis for targeted drug application which may translate into durable clinical benefits for these patients.
Cancer:
Gastrointestinal Stromal Tumor
Gene:
PDGFRA (Platelet Derived Growth Factor Receptor Alpha)
Drug:
Ayvakit (avapritinib)
Method:
PCR
Approvals
Date
Cancer
Gene
Drug
By
09/27/23
Other Approval