Could FDA's Approach to Emergency Use Authorizations for Covid-19 Testing nod toward IVD reform?
- scottblomberg
- Oct 14, 2020
- 3 min read
Updated: Oct 21, 2020
The FDA has issued an unprecedented number of Emergency Use Authorizations (EUAs) for In Vitro Diagnostic (IVD) tests for Covid-19 (SARS-CoV-2). I reviewed the FDA's EUA list (Ref. 1) and noted the similar if not equal treatment from the agency for tests developed by IVD manufacturers such as Roche and Siemens and Lab Developed Tests (LDTs). As many are aware, these two sources for testing technology have been regulated differently in the United States and have been subject to considerable discussion regarding reform.
The FDA has regulated IVD manufacturers in a fashion similar to medical devices. Manufacturers IVD tests are classified by their CLIA complexity rating (low, medium, high, waived) which determines where the testing can be performed based on the qualifications of the lab performing the test. (The waived classification is reserved for tests that can be performed without certification such as glucose and pregnancy tests.) These tests require FDA 510(k) clearance to be marketed which only comes after review by the FDA. In the case of new testing parameters or technologies, the tests may be subjected to pre-market approval (PMA) though often are reclassified to only require a 510(k) under the De Novo process.
On the other hand, LDTs are not subject to FDA review. They are regulated by CMS (Centers for Medicare and Medicaid Services) under the Clinical Laboratory Information Amendments (CLIA). These labs are treated primarily in the same fashion as the hospital-based labs who are the typical consumers of the manufacturers' IVD tests. (Ref. 2)
The difference between these two processes is vast though the technological difference between the tests can be minimal. This has created a tension in the industry opening up the market to increasingly more LDT providers and their tests with a lower regulatory burden. At the same time innovations have been held back from the IVD manufacturers because of their relative high regulatory burden. Because of this there has been a movement over the past several years toward consolidation but this would require legislation.
As recently as March 2020, the VALID act (Ref. 3) was introduced in Congress, which would codify the consolidation of the regulatory process for these tests and thus reform the entire US IVD regulatory landscape. Since the State of New York (LDT) received the first EUA for its Real Time PCR test on March 15, 2020, the agency has added 280 tests with roughly 1/3 of those authorizations going to LDTs and 2/3 going to IVD manufacturers.
The list itself is organized as follows:
- 182 Individual Molecular Diagnostic Tests
- 35 Umbrella Molecular Diagnostic Tests for CLIA Certified (High Complexity) Labs
- 6 Individual Antigen Diagnostic Tests
- 56 Individual Serology Tests
- 2 Individual Tests for the Management of Covid-19 Patients
Many of the companies associated with the tests I routinely saw at the annual AACC conference. The American Association for Clinical Chemistry is considered the preeminent conference for the IVD world.
- 7 Siemens Tests
- 6 Abbott Tests
- 5 Roche Tests
- 4 Quest Diagnostics Tests
- 3 Tests each for BD, Diasorin, Biofire, BioMérieux, Beckman Coulter, Luminex
- 2 Tests each for GenMark, Hologic, Cepheid, Thermo Fisher, Bio-Rad, Helix OpCo, DiaCarta
- 1 Test each for 154 manufacturers or laboratories
Looking through this list, I am struck by seeing laboratories including 13 university-based labs and testing giant Quest Diagnostics grouped alongside IVD manufacturers. It appears that in executing the process for issuing EUAs, the FDA has already consolidated to a certain extent the regulations for LDTs and IVD manufacturers in a manner envisioned by the VALID act.
Given the pandemic and the current election year politics, the VALID act has not moved beyond its introduction on March 5, 2020 by Reps. Larry Bucshon (R-IN) and Diana DeGette, (D-CO) in the US House of Representatives and Sen. Richard Burr (R-NC) and co-sponsor Sen. Michael Bennet (D-CO) in the US Senate. It is unclear how much attention the bill would have received if there was no pandemic.
Reform is much needed by the industry. In a recent panel discussion for Advamed's Virtual MedTech Conference, Lesley Maloney, Genentech, International Regulatory Policy Lead - Digital Health said "The regulatory framework we have today is ill suited and outdated for the complexity of test development and the demands of personalized health care." I agree with her sentiment and am hopeful that after the election, we can see progress on this front.
References:
Comments