> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# AdvaMedDx Comments on FDA Viral Mutation Impact Guidance
- URL: https://www.fdaweb.com/advameddx-comments-on-fda-viral-mutation-impact-guidance/
- Published: 2021-04-29T12:00:00.000Z
- Updated: 2026-09-14T16:57:00.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5149218

AdvaMedDx says its members develop *in vitro* diagnostic tests that facilitate evidence-based medicine, improve quality of patient care, enable early detection of disease, and reduce overall healthcare costs. In [comments](https://downloads.regulations.gov/FDA-2020-D-0987-0067/attachment%5F1.pdf?ref=fdaweb.com) on an FDA guidance, *Policy for Evaluating Impact of Viral Mutations on Covid-19 Tests*, the association says its members “anticipate virus mutations and, when designing tests, strive to target multiple areas of the viral genome, focusing on those sites that are least likely to mutate, in an effort to ensure such tests work for variants.”

The letter contains overall recommendations on these topics: FDA/industry partnership, appearance of sequences in public databases may not directly correspond with prevalence and level of clinical concern, utilization of *in silico* analysis, transparency and flexibility in protocols and reporting results, and different types of assays trigger different considerations.

It also has recommendations specific to molecular tests, antigen tests, T-cell tests, and serology tests.