Tuesday, January 25, 2022

MolDx Updates FAQ's and Forms for Tech Assessments

MolDx has updated some of its technology assessment spreadsheets (January 6, 2022) and updated some of its Frequently Asked Questions/FAQs, today on January 25.

Find the home page here.

Find the tech assessments here.

Find the FAQ web page here.   Also as preprinted PDF here.

TECH ASSESSMENTS

Updated forms for "Checklist" and "Hereditary Cancer Testing" and especially see AV/CV for MRD (NEW), minimal residual disease.  They have two types of forms for "solid organ allograft rejection" which aren't labeled new, but are new to me.

FAQs

Unfortunately, MolDx does not highlight revisions in its FAQs, so you have to read all of them and guess what's new.   

The PDF version offered does not exactly match the online Q&A version.  The online version starts with a question, "What Can I Do to Facilitate Review?"   

Some of the advice includes "detailed information on orthogonal methods" and "clear description of Intended Use" and one comment I particularly enjoyed (just about LOL.)  That last was, "We recommend someone familiar with the validation complete the documentation."