Absent FDA Guidance on Sequencing-Based Tests, Personalized Rx Experts Weigh in with Ideas | GenomeWeb

By Turna Ray

It's a given that technology moves faster than regulation, but when it comes to the US Food and Drug Administration's framework for laboratory-developed tests, the pace of progress has been particularly slow.

Four months after the FDA announced its intent to regulate LDTs, the agency has yet to put any meat on the bones of its plan to base forthcoming regulations on the intended use and the risk of a given test, and FDA officials have reiterated that they are keeping all ideas on the table.

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Feb
25
Sponsored by
Omicia

This webinar will demonstrate how ACMG's recommended variant scoring and classification rules may be applied to standardize reporting on sequencing test results within and across institutions. 

Mar
03
Sponsored by
Agilent Technologies

This webinar will discuss the use of a hybrid capture-based FFPE DNA sequencing methodology with the potential for advancing precision oncology studies. 

Mar
17
Sponsored by
Qiagen

This webinar will discuss Qiagen's approach to address two challenges facing NGS in the clinical research setting: lack of seamless workflow for routine clinical research use and truly relevant content to guide clinical research activities.