Science talks. Collaborative partnerships make it happen.

Science talks. Collaborative partnerships make it happen. The LDT rule. It is here, it has been announced. There are many comments, blogs, websites, articles, webinars, panel sessions and posts published about it and it affects many. Therefore, I am grateful to notice that all affected stakeholders, have been, are and keep partnering in development of […]

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 […]