FDA in Need of Data, Warns Against Using Tests/Test Materials in Unintended Ways

FDA Warns Against Research Use Only Materials Being Used Inappropriately

July 27, 2020

On July 15, 2020, the U.S. Food and Drug Administration (FDA) held its weekly town hall-style meeting where the in vitro diagnostics (IVD) community was invited to ask clarifying questions about the guidance on IVD testing last updated on May 4, 2020, allowing emergency use authorization (EUA) for qualifying diagnostic tests for SARS-CoV-2.

The key takeaways are listed below:

  • The FDA discourages complete test kits labeled as Research Use Only (RUO) being sold or given to clinical labs. RUO kits may be supplied to researchers, though the FDA encourages developers with RUO kits to submit an EUA to avoid improper use as a clinical diagnostic. The FDA is encouraging labs to select their kits from manufacturers present on either the notified or authorized lists by the Agency, rather than using RUO materials. The notified and authorized lists can be found on the FDA website. The FDA encourages adherence to the guidance concerning RUO materials.

  • If a developer wants to add a claim for testing asymptomatic patients to their previously authorized test, they would have to include a study on the sample type of choice using at least 20 consecutively collected positive specimens and at least 100 consecutively collected negative specimens. Contrived samples are not acceptable for this purpose, and a certain percentage of the positive specimens collected must come from asymptomatic patients. The results obtained by the developer’s test would need to be compared to the results obtained on the same sample set when testing using an authorized high-sensitivity assay. Additional details are now available in the Molecular Diagnostic Templates.

  • Serology tests are not currently used for immunity screening because the developer would have to claim that antibody presence equals immunity. Data proving immunity has not yet been generated.

More information:

How Exponent Can Help

Exponent’s multi-disciplinary team of biotechnology, medical device, and pharmaceutical industry professionals develop safety information for products and processes that comply with all pertinent standards, regulations, and best practices. With expertise in risk communication and FDA assessments, Exponent can assist in FDA label preparation and Pathway B or D submission for COVID-19 diagnostics. Our offerings also include reviewing diagnostic data to assess the completeness of the package for EUA or Pathway D submission.

The FDA held town hall-style meetings for the in vitro diagnostics community can ask questions to clarify the FDA's recently issued guidance for developing diagnostic tests for SAR-CoV-2. To read more on the key takeaways from each meeting and how Exponent can help, please see the links below:

July 9, 2020 - FDA Continues to Fight Back Against Under-Performing COVID-19 Diagnostic Assays

July 9, 2020 - Supply Shortages Spark New Concerns as the FDA Receives Record Numbers of In Vitro Diagnostic EUA Applications

June 1, 2020 - Accuracy Issues Still Plague Developers While FDA Looks to At-Home Testing

June 1, 2020 - FDA Publishes List of Developers Who Can No Longer Legally Market Their COVID Test

May 18, 2020 - FDA Focusing on Accuracy for In Vitro Diagnostics for COVID-19

May 5, 2020 - FDA Holds Third Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

April 30, 2020 - FDA Discusses First Authorized Home Collection Kit

April 17, 2020 - FDA Holds Second Town Hall Meeting to Clarify Emergency COVID-19 Diagnostics Development Guidance

April 13, 2020 - FDA Holds Town Meetings to Clarify Recent COVID-19 Diagnostics Development Guidance

April 13, 2020 - FDA Releases Updated Guidance on Diagnostics Testing as Response to COVID-19 Crisis