FDA issues draft guidance on next generation sequencing for infectious disease diagnostics

The US Food and Drug Administration (FDA) issued new draft guidance meant to establish the necessary performance characteristics for genetic sequencing tests used to diagnose infectious diseases.

Due to the complexity of these tests, FDA is proposing to regulate them as complete systems that encompass all processes from specimen collection through obtaining clinical results.

NGS Tests for Infectious Disease
In recent years, FDA has been working to develop its regulatory approach to so called next-generation sequencing (NGS) tests, which have the potential to revolutionize diagnostic testing.

Unlike traditional diagnostics that look for the presence of one, or several, biomarkers or genes, NGS-based tests can scan an entire genome for numerous variations or mutations that can identify specific strains of a disease or help guide treatment.

NGS-based tests for infectious diseases also differ from tests that sequence a patient’s own genome, as they are used to detect pathogens infecting a patient.

“Next generation sequencing has the capability to replace previous methods with a single approach to accomplish what might have required several different tests in the past,”FDA writes. “In contrast to human sequencing diagnostics, infectious disease sequencing diagnostics generally require rapid and actionable results, sometimes within hours, as delayed or incorrect initial diagnoses can result in fatalities.”

These tests also differ from other diagnostics due to the variety of specimens they can be used for, such as blood, stool or urine, as well as an array of diseases they can detect. According to FDA, these factors make it impossible to conduct “straightforward pre-analytical, biochemical, or bioinformatics processes” when characterizing NGS-based tests for infectious disease.

“Each unique specimen type may require a different nucleic acid extraction procedure, a different library preparation protocol, and even a different bioinformatics algorithm to generate the final clinical result,FDA writes.

Regulatory Oversight
FDA says it plans to regulate NGS-based tests for infectious diseases as Class II devices using a “one system” approach.

FDA yole

Read more:


Source: Regulatory Affairs Professionnals Society