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Roche launches CE-marked Cobas PIK3CA Mutation Test

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The Cobas PIK3CA mutation test is a real-time PCR test for the qualitative detection and identification of 17 mutations in exons 2, 5, 8, 10, and 21 in the gene encoding the catalytic subunit of PIK3CA in DNA isolated from formalin-fixed, paraffin-embedded tissue and is intended to identify patients with metastatic breast cancer whose tumors harbor these mutations. The test processes up to 30 samples per run on the Cobas z 480 analyzer and provides results in less than eight hours. Specimens are processed using the Cobas DNA Sample Preparation Kit to isolate genomic DNA from FFPET human specimens.

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