FDA Plans Public Workshop on High Throughput Sequencing Devices

The FDA will hold a public workshop April 1 to discuss the clinical and public health uses and performance validation of high throughput sequencing devices for microbial identification and detection of antimicrobial resistance markers.

While high throughput sequencing allows for identification and differentiation of a large number of microbial pathogens using a single sample, it presents a number of regulatory challenges, a Friday Federal Register notice says.

To address those challenges, the agency is seeking stakeholder feedback on the following:

• Identification of areas in which high throughput sequencing could be used as a diagnostic tool for infectious diseases and antimicrobial resistance markers from human specimens or clinical isolates;
• Development  and adaptation of standards for the microbial genome sequencing process, best practices for sample/library preparation, variant identification, genome annotation, output de-convolution, results interpretation, and reporting;
• Development of quality criteria to establish accurate reference databases and methods for curating and maintaining these databases; and
• Creation of a comparator paradigm for high throughput sequencing as the reference method to augment or replace existing methods.

Registrants will receive a draft of the FDA’s proposal for performance evaluation of high throughput sequencing devices prior to the workshop, the agency says. Results of the workshop will be translated into a draft guidance document, available on regulations.gov under docket no. FDA-2014-D-0191.

The meeting will take place from 9 am. To 4:30 pm. At the FDA’s White Oak, Md., campus. View the meeting notice at www.fdanews.com/ext/resources/files/03/03-10-14-Sequencing.pdf. — Lena Freund

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