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Month: September 2015

FDA’s Recent Letter to Pathway Genomics

The FDA’s Recent untitled letter to Pathway Genomics regarding their alleged direct-to-consumer marketing of the CancerInterceptTM Detect highlights the increased scrutiny facing lab-developed tests.

More information can be found here. The letter itself can be found here.

Author Robert YoungPosted on September 25, 2015February 17, 2017Categories NewsTags FDA, Genomics, LDT, Pathway

Coming Soon…

Coming Soon…


  • Quality Costs of Laboratory Information Management Systems
  • Insights into validation Open Source Software in a Regulated Environment
Author Robert YoungPosted on September 2, 2015February 17, 2017Categories NewsTags LIMS, Quality Management

Recent Posts

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