Proposed LDT Rule and Patient Considerations

Two females looking in the same direction

The LDT rule. I am going to keep this blog brief, because there are many posts on several media already, all with many thoughts and considerations. What I blog about today, is looking at it from patient perspective. As FDA points out in their proposed rule (PR), “an LDT to be an IVD that is […]

FDA Pilot Program Lab Developed Companion Diagnostics

Laboratory Research with data graphics

Today the FDA published a pilot program using minimal performance criteria for companion diagnostics. When reading it, I regard this could benefit patients and labs. FDA seems to be looking into no more one-drug-one test using minimal performance criteria. I certainly applaud this; it’s about care and well-being of patients. Reading the guidance, it seems […]