Imviva Biotech Granted FDA IDE Authorization for Cancer Treatment Trial - ExecEdge

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Imviva Biotech Granted FDA IDE Authorization for Cancer Treatment Trial

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Imviva Biotech Granted FDA IDE Authorization for Cancer Treatment Trial

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By Karen Roman

Imviva Biotech said it has FDA authorization for its Investigational Device Exemption application to use Adaptive Biotechnologies’ clonoSEQ assay in the TENACITY-01 trial to treat leukemia/lymphoma and minimal residual disease.

This authorization enables the company to use test results for patient management, identify eligible patients for enrollment, and evaluate treatment response, it stated.

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“FDA authorization of our IDE is a significant step forward as we advance the TENACITY-01 clinical trial,” said Jan Davidson-Moncada, MD, PhD, Imviva Biotech Chief Medical Officer. “These insights can accelerate clinical decision-making and ultimately support improved patient outcomes by enabling earlier intervention and more personalized treatment strategies.”