The public health emergency caused by the SARS-CoV-2 outbreak precipitated a significant upheaval for industries around the world. Pivotal stakeholders dedicated to the health and safety of the global population worked diligently to find solutions to tackle the novel COVID-19 virus and its effects. Global health organizations collaborated with healthcare experts to develop a range of diagnostic solutions and treatments that were regulated, effective, and usable for widespread applications.
In late 2019, SARS-CoV-2 began to spread, traversing the world with breakneck speed, and causing staggering infection rates.1 Governing bodies, healthcare professionals, manufacturers, and other stakeholders searched for solutions to this global health and safety risk.
Healthcare professionals (HCPs) and frontline workers leaned on personal protective equipment (PPE) to slow and reduce the spread of infections; however, the meteoric increase in resource demand was unprecedented, and the international supply chain could not immediately meet the rising needs. The global infrastructure was under extreme pressure, driving diagnostic developers to bring COVID-19 testing solutions, processes, and devices to the market.
The initial need was to determine how best to detect a COVID-19 infection in an individual. Tests fell into three broad categories2:
To commercialize diagnostic tests in the United States, developers were required to adhere to the FDA’s emergency use authorization (EUA) policy. EUAs permit the FDA to facilitate access to unapproved medical products or unapproved uses of approved medical products in public health emergencies. The EUA policy and framework had originally been finalized in January 2017, and the new COVID-19 circumstances required substantial revisions to accommodate the quickly evolving pandemic and enable rapid life-saving actions.3
The FDA initially prioritized laboratory-based tests and point-of-care (PoC) tests, to better inform decision-making. At-home testing—both prescription and over the counter (OTC) tests which relied on self-collection and self-testing—were integral in mitigating the spread of disease.4–6
The FDA’s initial response and desire to bring at-home testing to the market caused an unintended flood of unverified claims, falsified data, and illegitimate tests to be distributed to the public.7,8 As a result, hundreds of products were pulled, and more than 60 warning letters (as of March 2022) were issued.9 Additional considerations and reviews were required for authorization of home-based diagnostics due to the range of potential risks and issues that could arise10:
To help diagnostic developers navigate the EUA process, templates for preparation, submission, and authorization have been made available, on the heels of The New England Journal of Medicine citing, “the importance of authorizing medical products independently, of the basis of sound science, and not permitting market entry of tests without authorization.”10–12 The article then goes on to highlight the fruitful collaboration opportunities for public-private research, allowing accurate tests with independent assessment of assays to be available to the public.
By ensuring all stages and actions were completed in accordance with FDA guidelines and/or EUA requirements, diagnostic developers overcame the testing and regulatory challenges, from preclinical stages to study design and testing and through submission and filing.
Efficient clinical trial design was a key driver of these authorizations, factoring in medical and stakeholder needs while simultaneously building evidence-development strategies to provide a solid foundation for market accessibility.
Precision helped to bring many EUAs to market with diagnostic development support, innovative technologies, and a significant inventory of biospecimens that continue to support COVID-19 assay development programs.
1. World Health Organization. Coronavirus disease (COVID-19) pandemic. https://www.euro.who.int/en/health-topics/health-emergencies/coronavirus-covid-19/novel-coronavirus-2019-ncov. Accessed 7 June 2022.
2. Food and Drug Administration. In vitro diagnostics EUAs. https://www.fda.gov/medicaldevices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medicaldevices/vitro-diagnostics-euas. Last updated 17 March 2021. Accessed 7 June 2022.
3. Food and Drug Administration. Emergency use authorization of medical products and related authorities: Guidance for industry and other stakeholders. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/emergency-use-authorization-medical-products-and-related-authorities. Last updated 17 October 2018. Accessed 7 June 2022.
4. Centers for Disease Control and Prevention. Guidance for SARS-CoV-2 point-of-care and rapid testing. https://www.cdc.gov/coronavirus/2019-ncov/lab/point-of-caretesting.html. Last updated 19 January 2022. Accessed 7 June 2022.
5. Shuren JE. Food and Drug Administration. Coronavirus (COVID-19) update: FDA issues authorization for Quidel QuickVue at-home COVID-19 test. https://www.fda.gov/newsevents/press-announcements/coronavirus-covid-19-update-fda-issues-authorizationquidel-quickvue-home-covid-19-test. Published 1 March 2021. Accessed 7 June 2022.
6. Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes first COVID-19 test for self-testing at home. https://www.fda.gov/news-events/pressannouncements/coronavirus-covid-19-update-fda-authorizes-first-covid-19-test-selftesting-home. Published 17 November 2020. Accessed 7 June 2022.
7. Hale C. FDA leaders recount flaws in 2020’s open-door policy for COVID-19 antibody tests. https://www.fiercebiotech.com/medtech/fda-leaders-recount-flaws-2020-s-opendoor-policy-for-covid-19-antibody-tests. Published 16 February 2021. Accessed 7 June 2022.
8. Food and Drug Administration. Template for manufacturers of molecular and antigen diagnostic COVID-19 tests for non-laboratory use. https://www.fda.gov/media/140615/download. Published 29 July 2020. Accessed 7 June 2022.
9. Food and Drug Administration Warning Letters. https://www.fda.gov/inspectionscompliance-enforcement-and-criminal-investigations/compliance-actions-andactivities/warning-letters. Current as of 7 June 2022. Accessed 7 June 2022.
10. Food and Drug Administration. Policy for coronavirus disease-2019 tests during the public health emergency (revised). https://www.fda.gov/regulatory-information/searchfda-guidance-documents/policy-coronavirus-disease-2019-tests-during-public-healthemergency-revised. Accessed 7 June 2022.
11. Food and Drug Administration. Emergency use authorization. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatoryand-policy-framework/emergency-use-authorization#covidinvitrodev. Current as of 7 June 2022. Accessed 25 March 2022.
12. Shuren J, Stenzel T. The FDA’s experience with Covid-19 antibody tests. https://www.nejm.org/doi/10.1056/NEJMp2033687. Published online 18 February 2021. Accessed 8 March 2022.
Jo-ann Fabia Gonzales is an experienced regulatory affair professional with more than 20 years of experience in biotechnology. Her career has a rich focus on medical devices and IVD regulatory support.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
