The Critical Path Institute said this week that the Japanese Pharmaceuticals and Medical Devices Agency has approved its seven-protein biomarker panel for use in detecting drug-induced kidney damage.

The decision is the first ever biomarker qualification decision by the PMDA and means that the panel is qualified for voluntary use in nonclinical safety studies and that data generated using the panel can be submitted to the agency on a case-by-case basis for use in monitoring drug-induced renal toxicity in humans, Critical Path said in a statement.

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