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The Disruption Series: Decreased Hurdles to COVID Diagnostics

How the pandemic is changing regulatory pathways

This is the sixth piece in the Lionbridge Disruption Series, a collection of commentary from life sciences experts on how the industry is changing as a result of the COVID-19 crisis.

FDA Policy Changes to Accelerate Coronavirus Diagnostic Testing

In March, the FDA released a policy for diagnostic tests for coronavirus to guide clinical laboratories, commercial manufacturers and FDA staff during the COVID-19 pandemic. Diagnostic tests for detection or diagnosis of the novel coronavirus (SARS-CoV-2) can be granted an Emergency Use Authorization (EUA) by the FDA.

This enables rapid development, manufacturing and distribution of tests under a public health emergency. Section 564 under the Federal Food, Drug and Cosmetic Act allows the use of unapproved medicinal drugs and devices under specific circumstances during emergencies such as the current pandemic.

Despite the extreme urgency of being able to detect and test for coronavirus, the validation of diagnostic assays remains important also under a pandemic such as COVID-19. A false negative result of a COVID-19 test can have consequences not only for the patient but also for public health in general. A patient who believes themselves not to be infected may unknowingly pass the virus on to dozens of others, magnifying the effect of an incorrect test. A false positive, on the other hand, can take precious hours away from contact trackers’ efforts as they try to retrace the patient’s step and determine whom to contact about exposure.

While test validation is not waived by the FDA, the policy does allow manufacturers to develop and distribute SARS-CoV-2 test kits before submission to the agency. (That submission  is expected within 15 business days after validation of the test.) The submission of the EUA request to the FDA should include fact sheets for healthcare providers and patients, as well as instructions for use and proposed labeling/package inserts. Test kits that have received a Letter of Authorization under the EUA program will then be listed on the FDA webpage, along with both fact sheets and Instructions for Use.

Remove Language Barriers for Labeling and Fact Sheets

Content intended for patients or healthcare professionals may require expedited translations for test kits being distributed internationally or to non-English speaking audiences. Lionbridge is uniquely positioned to support any global distribution of test kits because of our scale, our expertise in translating labeling and patient content for medical devices, and our industry-leading breadth of language solutions.

For more on our languages and regions of expertise, talk to someone on our team.

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Pia Windelov
Pia Windelov