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Foundation Medicine Says Tumor Mutational Burden Reporting Issue on CDx Test Is Resolved

NEW YORK (GenomeWeb) – Foundation Medicine said this week that it quickly resolved an issue regarding reporting of tumor mutational burden (TMB) by its FoundationOne CDx test that had surfaced in October.

According to a statement, the company discovered a reporting issue in late October that resulted in potentially inaccurate reporting of TMB. "[O]ur team quickly discovered during our routine curation of reports high TMB in an indication where it typically does not occur. As a critical component of our quality system, our team was able to halt testing temporarily, minimizing the impact to a limited number of FoundationOne CDx cases," the firm said.

The issue affected tests during a short period of time and "the root cause of the issue was quickly identified, addressed, and resolved," the company said. "Immediately following discovery, we informed physicians that their reports could include an incorrect test result."

Foundation Medicine also voluntarily informed the US Food and Drug Administration about the issue and the action it took to address and resolve it. As a result, the FDA last month listed the problem in its Medical Device Recall Database, noting that an incorrect TMB test result may have been reported for up to 800 physician reports. This listing will be updated once the FDA determines that the recall has been terminated, according to the firm.

Foundation Medicine noted that although TMB reporting is part of its FoundationOne CDx test, it is not associated with an FDA-approved companion diagnostic indication at the moment.

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