[heavy] FDA issued two draft guidelines for in vitro diagnosis of NGS

Recently, the National Institutes of Health announced that it has invested US$55 million in precision medical programs and established a national precision medical research program with at least 1 million volunteers. The FDA has published two draft NGS in vitro diagnostic guidelines.

Guideline 1: Guidelines for the in vitro diagnosis of genetic diseases based on NGS

The first guide is entitled "Guidelines for the In Vitro Diagnosis of Genetic Diseases Based on NGS" and is divided into eight parts, including the preface, background, scope, classification of NGS tests for hereditary diseases, pre-marketing review, and elements involved in genetic disease NGS testing. Recommendations, amendments, and other resources for the design, development, and validation of genetic diseases for NGS testing.

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This guide will provide design, development, and validation guidance for NGS testing of hereditary diseases; test developers can follow this guide to prepare for the launch of the test; the recommendations in this guide apply to the detection of hereditary diseases, regardless of the outcome It can be applied to both patients and medical staff, but additional recommendations and management are needed when the test results are directed to the consumer.

This guideline does not apply to NGS testing for diagnostic purposes only, nor to screening, microbial genetic testing, risk prediction, cell-free DNA testing, fetal testing, preimplantation genetic testing, tumor genome testing, RNA sequencing Or tests for the purpose of diagnosis, as these tests have other features not covered by the guide.

Classification and pre-market review of genetic diseases for NGS testing

To date, the FDA has learned about some of the monogenic diseases, disease specificity, targeted detection, and NGS testing. However, the FDA has not classified the NGS test for hereditary diseases, so this type of test is automatically classified as Class III in the law. There is no legal market management to review the notification of NGS testing before listing. Therefore, the draft guide considers the classification of NGS-based genetic disease tests as Class II tests and exemption from pre-market notifications. In the long run, the FDA considers how to make these guidelines a standard specification and whether it can waive the pre-market notification requirements through special FDA management. According to the guidelines, such tests must be approved by the FDA before they can be marketed.

Elements involved in genetic disease NGS testing

NGS-based clinical testing typically involves reagents, consumables, instruments, and software. Different detection targets correspond to different reagents, consumables, instruments and software, so different NGS inspections have different design schemes and workflows.

Guidance on the design, development and validation of genetic diseases for NGS testing

The guide states that developers should first identify the indications for testing as this determines the direction of detection; developers should proactively determine the type of study and thresholds when determining appropriate detection performance. After the design and development of the test is completed, a test should be performed to verify that the predefined effect is achieved. If one of the verification results does not meet the requirements, the test must be modified and re-verified until the verification results reach the predefined performance. The design, development and verification are a cycle and should be kept intact at all times. In the process, developers should document all test actions, decisions, and results, as well as the reasons for performing these tests.

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