On February 17th, 2021 the Biden Administration announced an expansion of the Federal strategy to test the population for SARS-CoV-2 with a three pronged approach:
- Expand COVID-19 testing for schools and underserved populations ($650 Million);
- Ramp up the domestic manufacturing of testing supplies and raw materials ($815 Million); and
- Increase genomic sequencing of the virus to better prepare for the threat of variants ($200 Million).
Each of these goals requires significant and targeted investment at all levels of the diagnostics supply chain from testing locations to finished device manufacturers to the suppliers of raw materials.
The administration has set aside a total of $1.665 billion dollars across all three initiatives. The $650 million dollar investment into new testing is intended to translate into 25 million new tests delivered monthly to regional hubs across the US that are under the auspices of DoD and HHS. It is not clear from the administration’s announcement what the total number of tests that are expected to be realized by this investment, but the news is still overwhelmingly positive for manufacturers still working their way through the EUA process. This initiative puts an emphasis on targeted testing of the population that will occur outside the traditional laboratory setting. This is consistent with a shift in FDA’s focus for diagnostic tests from CLIA Lab runs assays to non-laboratory sites such as Point-of-Care and Home Use. HPM recently released a blog post on FDA’s changing priorities (“Beware EUA Deprioritization”)
The lion’s share of the monies ($815 million) is slated for domestic manufacturing of testing materials. Specifically, filtered pipette tips, nitrocellulose, and injection molded reagent container closures. This additional investment is heartening news as many manufacturers have experienced delays in device development over the last 12 months that are directly traceable to the ability to source samples, reagents, controls, and basic testing supplies. The infusion of federal money toward domestic manufacturing may favor EUAs that bolster the domestic supply chain.
The final pool of monies ($200 million) is slated to address an ever-increasing concern for the pandemic which is the mutation of the SARS-CoV-2 virus and the rise in new mutant strains that may impede our march toward herd immunity and a return to normalcy. This increased funding for virus sequencing may aid in the rapid identification of new variants and allow for the development of multi-valent vaccines or boosters to maintain the efficacy of the vaccination program. This money will likely not impact the EUA work that the Center for Devices and Radiological Health is doing in the review of new diagnostic EUAs.
This announcement comes amidst a series of public notices and statements from FDA regarding their concern with genetic mutations of the virus impeding the performance of diagnostic tests. On February 4th 2021, FDA provided a “Coronavirus (COVID-19) Update” where the agency stated:
For diagnostics, we have been monitoring for new mutations, identifying and working with developers of tests whose performance may be adversely impacted by them, and communicating with the public when helpful information becomes available. At this time, we believe the risk that the currently known mutations will impact overall testing accuracy of molecular tests is low. Moving forward, we are considering expanding the role of in silico monitoring by sponsors prior to and following authorization to assess for mutations that impact the performance of the test, test designs to minimize the impact of new mutations and ways to label authorized products to be transparent about what we know the test can detect.
This update was followed-up later in the month on February 22nd, 2021 with a new policy “Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests.” With issuance of this policy statement, FDA is putting industry on notice that due to the rise of mutations, post-authorization monitoring of assay performance will be a key consideration for an EUA. In this policy FDA states:
During FDA’s review of an EUA request for a COVID-19 test, FDA intends to consider the performance of the test across all known variants, as well as the developer’s plans for post authorization monitoring.
For industry, the only way to keep up with new mutations is to run an analysis through a sequence database, like the one maintained by the National Center for Biotechnology Information (NCBI). It is expected that this increased funding will improve the quality of databases that are used to monitor the pandemic and that industry uses to evaluate inclusivity of their tests.
In this policy update, FDA also gives granular feedback to industry on FDA’s expectations for developers of molecular diagnostic tests. However, the feedback for developers of Serology and Antigen tests is high level with more feedback from the Agency being promised in future updates to the EUA templates. In light of FDA’s policy, companies with pending EUAs or those who are in the process of preparing their submissions to FDA should be proactive and develop plans for the evaluation of mutations as FDA has applied new thinking and requirements retroactively to EUA reviews.