This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group.
CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from the market. Also, the FDA says 45 serology tests should no longer be distributed, and among those tests, 21 had been granted emergency use authorizations and 11 were removed voluntarily by the manufacturers.
NEW EVIDENCE PRODUCED BY FEDERAL RESEARCHERS indicates that a substantial number of COVID-19 serological tests that currently have a Food and Drug Administration (FDA) emergency use authorization (EUA) may fail to perform to the minimum requirements established by the FDA.
This situation is a cause of great concern for pathologists and clinical laboratory administrators throughout the country because of the huge—and steadily increasing—demand for accurate and reliable COVID-19 serological tests.
Yet, the latest findings of a federal research laboratory show that 73% of the COVID-19 serology tests with an FDA EUA reviewed to date fail to meet the requirements established by the FDA!
This is extremely bad news for clinical laboratories in the United States. They rely on the FDA to issue standards and clear diagnostic instruments and tests for market that perform reliably, accurately, and produce high-quality test results for use in clinical settings.
Moreover, labs are at risk for liability, malpractice and similar other legal claims if they produce lab test results that fail to meet the standards for accuracy and clinical care. For this reason, the FDA’s careful review and clearance of a medical device or a diagnostic test is meaningful and important for clinical laboratories, the physicians who order tests, and the patients being tested.
Since June 1, the FDA has twice released sets of performance data on COVID-19 serology tests with EUAs that were generated by independent evaluations conducted by the FDA and the National Cancer Institute (NCI). Based on the assessment of each test’s performance, the FDA then assigned a marketing status to those tests.
The first data release was on June 4. The FDA announced that, of the three COVID-19 serology tests evaluated, only one could continue to be marketed.
Eleven Tests Evaluated
The next data release came on June 19. The FDA and NCI had completed evaluations on a total of 11 tests and determined that only three can continue to be marketed under the EUAs the agency granted. This meant that eight of the tests reviewed—each of which had an EUA—could no longer be marketed.
These poor results from the FDA’s own review of COVID-19 serology tests with EUAs raise major concerns. Across the nation, many labs are negotiating to purchase and validate COVID-19 serology tests that have EUAs.
The fact that of the first 11 such tests reviewed by a federal laboratory, eight tests can no longer be marketed raises a valid point: can a clinical lab be confident that when it purchases a COVID-19 serology test with an EUA for use in patient care, the test will deliver accurate and reproducible results?
In truth, the fact that the majority of COVID-19 serology tests reviewed to date by federal researchers cannot be marketed is now the latest chapter in an ongoing series of bad decisions and missteps happening at the FDA.
Experts in diagnostics and laboratory medicine have publicly criticized the FDA for certain actions it has taken in its response to the COVID-19 pandemic. At a time when state governors and the president want to unleash the full potential of clinical labs to respond to the pandemic, certain of the FDA’s directives have been counter-productive in enabling the nation’s labs to deliver the large volumes of testing required to manage the pandemic.
The FDA’s release of research lab findings that 73% of COVID-19 serology tests reviewed failed to meet requirements is the latest chapter in a story that began with the COVID-19 outbreak earlier this year. The serological test part of this story began in March.
On March 16, the FDA issued rules allowing lab test manufacturers to market serological tests for the coronavirus with little or no agency review. At the time, the agency said it was granting “regulatory flexibility for developers offering such tests without FDA review and without an emergency use authorization (EUA).”
The test manufacturers needed to notify the agency that they had validated their serological tests and provide disclaimers about the limitations of the tests. “The FDA does not review the validation or accuracy of the data for these tests unless an EUA is submitted,” said the federal agency at that time.
No Performance Analysis
The suspension of FDA review for COVID-19 serological tests was designed to both shorten the time for such tests to reach the market and increase the number such tests available for purchase and use by clinical laboratories. But listing tests without a traditional review by the federal agency created exactly the problem predicted by critics.
They foresaw that the FDA’s relaxation of rules governing COVID-19 serology tests would allow companies—many without any operating history—to list a COVID-19 assay with the FDA, supported by minimal data, then offer it in the marketplace.
After the FDA opened the floodgates to test developers, more than 200 serological tests for the coronavirus were listed on the FDA’s registry and poured into the market in March and April. It meant clinical laboratories were on their own to determine which of these tests would be accurate and high quality and which would not.
Strong evidence that FDA officials realized the folly of issuing the relaxed rules for allowing COVID-19 serology tests into the market with review came just seven weeks later. On May 4, the agency reversed course and issued new guidance on serology testing. (See TDR, “FDA Replaces March 16 Serology COVID-19 Rules,” May 11, 2020.)
Poorly-Performing Tests from China
To the credit of the FDA, it is proceeding with an assessment of COVID-19 serology tests that are listed on its site. This work is being done at the Frederick National Laboratory for Cancer Research (FNLCR), a federal research and development center affiliated with the NCI.
Yet, it is a troubling fact that the first results of these evaluations show that eight of the 11 COVID-19 serology assays evaluated by FNLCR are to be removed from the market. These findings put a cloud over many of the COVID-19 serology tests still listed on the FDA’s site.
One expert on diagnostic testing told The Dark Report that the FDA and FNLCR testing program appeared to focus on the “poorly-performing tests coming from China and from other parts of Asia and being offered for sale in the United States.” He further noted that “the findings are unsurprising and should not be extrapolated to tests from known and reputable manufacturers.”
Have you bought any serology test kits whose quality you’re now concerned about? Please share your thoughts with us in the comments below.