Question · Q3 2025
Rick asked about the planned December plant shutdown for routine maintenance, including its timeline for reopening, and whether any biopsies collected before the temporary pause were not yet sent to manufacturing, requiring potential re-biopsy.
Answer
CEO Vishwas Seshadri confirmed the shutdown from mid-December to early January for mandated FDA maintenance and recalibrations. SVP, Chief Technical Officer, and Chief Scientific Officer Brian Kevany reiterated the schedule. Vishwas Seshadri clarified that no biopsies were collected but not sent to manufacturing during the pause, as the company proactively halted collections to avoid patient inconvenience until the assay issue was resolved.
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