Roche received complaints from customers reporting the generation of false mutation detected results for the exon 20 insertion (ex20ins) mutation when using the cobas® egfr mutation test v2.During in-house testing using customer-provided ffpet samples, an ex20ins false mutation detected result was reproduced for one out of 8 ffpet samples, which was processed following the validated sample preparation method from the instructions for use.Although the majority of cases reported were from users using ffpet samples, the generation of false mutation detected ex20ins results with plasma specimens was reported in one case.A false mutation detected ex20ins result could lead to harm under specific scenarios.Consignees have been notified of the issue with instruction to follow the instructions for use for sample input requirements.Additionally, if an ex20ins mutation detected result is generated with the cobas® egfr mutation test v2, customers must confirm the result with another method (e.G., sequencing or other pcr-based tests).
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A customer from greece alleged a false positive result with 1 patient sample using the cobas® egfr mutation test v2.The alleged sample was initially tested with the cobas® egfr mutation test v2 and generated a "mutation detected" result for exon20ins.The same sample was retested using next generation sequencing (amoydx essential ngs panel kit with illumina nextseq) assay and generated a mutation detected result for ex20 (nm_005228.5, exon20, c.2347_2348insg) which is a different mutation than the exon20ins mutation detected by cobas® egfr mutation test v2.The cobas egfr assay result was not reported to the patient and no harm was alleged.
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