Medical device manufacturer, Roche Diagnostics, has issued a medical device safety alert concerning its cobas EGFR Mutation Test, v2 CE- IVD and cobas cfDNA Sample Preparation Kit.
According to the manufacturer, several mutations (L858R, Exon 19 deletion, T790M) inconsistently generated "No Mutation Detected" (i.e. False Negative) results with the cobas EGFR Mutation Test, v2 when utilising the cobas cfDNA Sample Preparation kit during internal studies using contrived plasma specimens.
There is no impact when using the cobas DNA Sample Preparation Kit with the cobas EGFR Mutation Test, v2 to test formalin-fixed paraffin-embedded tumour (FFPET) tissue samples.
Patients with a false negative result for the mutations may be denied the prospect of prolongation of disease control and survival (8-12 months).
The manufacturer will update the Instructions for Use (IFU) for the cobas EGFR Mutation Test, v2 and cobas cfDNA Sample Preparation Kit to revise the handling of the eluate for plasma specimens prior to amplification and detection. Users are advised to follow the revised instruction until the updated IFU become available.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 18 April 2016