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Japanese Regulators Approve Critical Path's Protein Biomarker Panel for Drug Toxicity Studies

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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.

The biomarker panel was developed by the Predictive Safety Testing Consortium, a public-private partnership launched by Critical Path in 2006 that includes sixteen global pharmaceutical companies.

The seven biomarkers in the panel are kidney injury molecule-1, albumin, total protein, β2-microglobulin, cystatin C, clusterin, and trefoil factor 3. PMDA agreed with the PSTC's claims that these protein biomarkers can add information for detecting drug-induced nephrotoxicty in preclinical rat safety studies when used with the current standard biomarkers, serum creatine and blood-urea nitrogen.

The agency also said that six of the biomarkers – KIM-1, albumin, total protein, ß2-microglobulin, cystatin C, and clusterin – outperformed the current standard biomarkers.

The PSTC submitted the panel to PMDA in August 2009, and the agency made its decision last month.

In 2008, the biomarkers received approval from the US Food and Drug Administration and the European Medicines Agency for limited use in nonclinical and clinical drug development. The PTSC detailed this regulatory submission and approval process in a paper published in the May issue of Nature Biotechnology.

The PMDA approval means the biomarkers are now qualified at the same level by all of the regulatory agencies comprising the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, which "which will significantly promote use of these biomarkers in a global setting," Critical Path said in a statement.

Additional guidelines regarding biomarker qualification are forthcoming this summer. As Federico Goodsaid, associate director for operations in genomics at FDA, told ProteoMonitor this May, over the last year the agency has been working to formalize the progressive qualification process under which it approved the PSTC submission in 2008 and will be releasing a draft guidance detailing the steps of the process this summer (PM 5/14/2010).

Also this summer, the IHC will be releasing guidelines covering the structure, content, and format of biomarker qualification submissions.

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