FDA Continues to Fight Back Against Under-Performing COVID-19 Diagnostic Assays

The List of Tests Barred From Market in the US Is Growing, as Is the Guidance From the FDA Around Potentially Lethal Mislabeled VTM and Different EUA Regulations

July 9, 2020
In June 2020, the FDA held weekly town hall-style meetings 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:

  • Any viral transport media (VTM) that uses guanidinium thiocyanate cannot be used in conjunction with diagnostic platforms that use bleach due to the potential formation of cyanide gas. The FDA became aware of this issue several weeks ago and warned consumers of the dangers. Some VTM manufacturers are distributing VTM without proper labeling, making it difficult for consumers to know what ingredients they contain. The FDA is working with the manufacturers to correct the problem and requests anyone seeing improper labeling of VTM please contact them, either via MedWatch or by emailing CDRH-EUA-templates fda.hhs.gov.

  • For any direct detection assay with accuracy metrics below what is expected for molecular tests, currently 95%, the FDA is requiring language be added to the instructions for use stating that a negative result should be considered a “presumptive negative.” Direct antigen tests fall into a different category and are required to demonstrate at least 80% sensitivity relative to a high-sensitivity molecular test.

  • As of June 24, 2020, the FDA has removed 50 tests from the market for inaccuracy and performance issues. A list of the tests that have been removed is available on the FAQ page. Removal by the FDA means consumers will no longer be allowed to purchase those tests, nor will those tests be allowed to enter the country via importers.

  • If a facility has received EUA authorization and wants to add additional manufacturing sites under the EUA, they do not need to submit a separate EUA for the new manufacturing sites. They can work with their lead reviewer to add the additional manufacturing sites and gather the additional information necessary to make those new manufacturing sites fully authorized.

  • The FDA has added guidance to the EUA molecular diagnostic templates for validation testing for commercial manufacturers and laboratories who wish to make claims regarding pooling of samples or performance in asymptomatic populations.

  • Additional guidance has been released for COVID-19 reporting requirements. All seeking to develop tests are encouraged to take into account these requirements.

  • The FDA is experiencing a large volume of submissions. Priority review is being conducted on EUA applications that have data supporting their applications and those tests that are deemed to be of the greatest public health importance, including point-of-care testing, home-collection, home-testing, and high-throughput tests. Additionally, any EUA applications that are not eligible to market under the notification pathway are also being prioritized if they have data to review, such as those with claims regarding performance in pooled samples or asymptomatic populations.

  • The FDA strongly encourages all developers to use their EUA templates when preparing an application. This facilitates a streamlined review at the FDA.

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 - 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