News & Events

• November 13, 2015
  

  C-Path’s Polycystic Kidney Disease Outcomes Consortium Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD

  November 13, 2015 C-Path’s Polycystic Kidney Disease Outcomes Consortium Secures EMA Qualification Opinion for Enrichment Biomarker in ADPKD TUCSON, Ariz., November 13, 2015 – The Critical Path Institute (C-Path) announced today that the European Medicines Agency (EMA) rendered a positive qualification opinion to C-Path’s Polycystic Kidney Disease Outcomes Consortium (PKDOC) for total kidney volume (TKV) as a prognostic......
• August 30, 2015
  

  Critical Path Institute’s Polycystic Kidney Disease Outcomes Consortium Secures FDA Qualification for Enrichment Biomarker in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

  August 31, 2015 Critical Path Institute’s Polycystic Kidney Disease Outcomes Consortium Secures FDA Qualification for Enrichment Biomarker in Autosomal Dominant Polycystic Kidney Disease (ADPKD) TUCSON, Ariz., August 31, 2015 – The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration (FDA) has issued a qualification decision in the form of a......
• June 1, 2015
  

  Critical Path Institute Secures Regulatory Support For Autosomal Dominant Polycystic Kidney Disease (ADPKD) Biomarker

  TUCSON, Ariz., June 1, 2015 — The Critical Path Institute (C-Path) announced today that the U.S. Food and Drug Administration (FDA) has issued a Letter of Support to C-Path’s Polycystic Kidney Disease Outcomes Consortium (PKDOC) for the use of total kidney volume (TKV) as a prognostic biomarker to select patients for clinical trials of new therapies for Autosomal Dominant Polycystic Kidney Disease (ADPKD).
  ADPKD is a debilitating genetic disease affecting more than 600,000 Americans and 12 million people worldwide. It is characterized by progressive enlargement of the kidneys due to the formation and growth of cysts. TKV is a measurement of the impact of ADPKD on the size of the kidneys and is believed to be predictive of a future decline in kidney function