Tempus seeks FDA premarket approval for xT-Onco assay

2019 04 27 00 03 6781 Dna Sequence Shadow 400

Tempus has submitted a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its xT-Onco broad-panel DNA sequencing assay.

In addition to premarket approval, the submission includes companion diagnostic claims, tumor profiling claims, and microsatellite instability status, using DNA isolated from formalin-fixed paraffin embedded tumor tissue specimens and matched normal specimens.

The assay will be performed at Tempus' next-generation sequencing lab in Chicago.

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