A First Look at a New Review Paradigm

Monday, April 14, 2014

FDA celebrated April Fool's day by hosting a free public workshop entitled "Advancing Regulatory Science for High-Throughput Sequencing Technologies for Microbial Identification and Detection of Antimicrobial Resistance Markers." 

The objective for this program was (1) to obtain feedback on possible studies to evaluate high throughput sequencing (HTS) devices as an aid in microbial diagnostics and (2) to gain a better understanding for clinical implementation strategies for these new products. In order to provide focus to this discussion, FDA issued a discussion paper on this topic and developed a series of questions for public presentation.

Some two dozen speakers and panelists were selected to lead the discussion. The program appeared to be largely driven by government (FDA, NIH, CDC, Military) participants although outside guests included academics from Harvard, Washington's Children's Medical Center, and the Lawrence Livermore National Laboratory.

A central premise was that HTS devices were likely to present regulatory challenges to the traditional FDA mechanism for validation of new IVDs. New paradigms are needed to reduce the burden encountered during the clinical evaluation of new targeted multiplex assays for microbial diagnosis.

At the heart of the discussion was the proposal for a new comparator paradigm that could enable the use of HTS technologies as a single comparator to determine the specific microbial composition of a clinical specimen. Such a paradigm would presumably aid in determining clinical truth for multiplexed nucleic acid based assays.

The cornerstone for the approach being considered is a public database that is populated with sequence entries that meet an acceptable level of quality. This database would serve as the comparator to verify results obtained during the clinical evaluation of HTS devices and would potentially establish the clinical performance of these devices. One of the sessions focused on what type of meta-data would be included in such a database.

The good news is that FDA is thinking ahead for novel approaches address novel technology. Without doubt this initiative seems quite out of the box. 

The bad news is that the workshop raised more questions than answers and there are many outstanding issues to address before such a new approach can become a reality. FDA said they welcome comments on approaches

So the proverbial check is very much in the mail. 

FDA did provide a useful summary of a thoughtful day of discussion (hats off to Uwe Scherf for pulling this off!). But at the end of the day the advice was practical but familiar. For those interested in moving forward with products now "start talking with FDA."

FDA is seeking input on the draft white paper that was distributed. The link to the discussion paper, workshop overview and further links to the recorded Webcast can be found here


Tags: FDA, Policy, Public Statements

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