May 5, 2020
Policy for diagnostic tests for COVID-19 during the public health emergency: immediately in effect Guidance for Clinical Laboratories, Commercial Manufacturers & Food and Drug Administration Staff
On April 15, 2020, FDA held its third town hall-style meeting where the in vitro diagnostics (IVD) community was invited to ask clarifying questions regarding the guidance on IVD testing FDA released on March 16, 2020, allowing emergency use authorization (EUA) for qualifying diagnostic tests for SARS-CoV-2.
The key takeaways from the town hall meeting on April 15, 2020, are listed below:
- A popular testing kit can suffer from unintended dilution when viral transport media (VTM) is used, which reduces the sensitivity of the assay. Abbott Laboratories is updating their labeling and instructions for use to prevent this issue for future testing. On April 21, 2020, FDA authorized an amendment to the ID NOW EUA "to remove nasal, nasopharyngeal or throat swabs eluted in viral transport media swabs in VTM as a specimen type."
- Certain brands of tests use bleach, which can combine with the guanidine thiocyanate found in some types of transport media to produce cyanide gas. A warning about this has been placed on the FAQ page.
- The first EUA was granted for a saliva-based test on April 10, 2020, to Rutgers Clinical Genomics Laboratory for use in a health care setting.
- As of April 15, 2020, there have been three serology EUAs issued, Cellex, Chembio Diagnostic System, and Ortho Clinical Diagnostics. These tests are authorized for use in Clinical Laboratory Improvement Amendments (CLIA)-designated high- and moderate-complexity laboratories.
- FDA reiterated that serology tests listed under Pathway D "are only for high complexity labs. They are not to be used with moderate complexity labs or in point of care near patient settings nor in a home."
- The interagency program for validating the accuracy of developer's tests against patient samples has commenced. FDA is looking into alternative EUA pathways for developers who participate in the program.
How Exponent Can Help
Exponent's multidisciplinary 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, pathway D, or Umbrella Pathway submission for COVID-19 diagnostics. Our offerings also include reviewing diagnostic data to assess the completeness of the package for EUA, Umbrella Pathway, or pathway D submission.