Roche identified that a customer outside of the united states was using a non-commercial egfr tissue asap version (cobas® egfr tissue asap v1.0.0.1512), which is a pre-launch version that was never commercialized.The customer should have been using the commercial tissue asap version: cobas® egfr tissue p1 ap version 1.0.0.1560 (launched 2015).In the customer¿s data, 6 samples were identified with a "mutation detected" result for the ex20ins mutation using the non-commercial tissue asap (v1.0.0.1512); if the customer was using the commercialized tissue asap (v1.0.0.1560), the questioned results would have been reported as "no mutation detected" for the ex20ins mutation.No impact is expected for other egfr mutations reported by the cobas® egfr mutation test v2, including ex19del, g719x, s768i, t790m, and l861q.It is to be noted that the ex20ins "mutation detected" results were not reported out; rather, they were reported as "indeterminate".Also, the customer had the commercialized tissue asap (v1.0.0.1560) installed on its system in january 2022.The use of the non-commercial tissue asap is not likely to cause serious adverse health consequences.Customers were previously instructed in august 2021 to confirm ex20ins "mutation detected" results generated with the cobas® egfr mutation test v2 with another orthogonal method (e.G., sequencing or other pcr-based tests) before releasing the final test reports.If the confirmatory testing is performed as instructed at the customer¿s sites, the use of cobas® egfr mutation test v2 with the non-commercial tissue asap version v1.0.0.1512 for ex20ins mutation detection will be not likely to cause adverse events in the affected patient population.Current information suggests that this situation is unique to a single overseas country.The relevant roche affiliate organization will be notified to ensure all customers in that country are using the commercial asap and that any local copies of the non-commercial asap are quarantined and locally destroyed, immediately.--- added info in b6 and updated date of event to earliest run date.Added b14 analysis of production records and b11 historical data analysis.
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