New FDA Policy Significantly Limits Serological Testing

April 13, 2020By Jeffrey N. Gibbs & McKenzie E. Cato & Serra J. Schlanger

During the COVID-19 pandemic, there is widespread agreement that one of the most important steps the government can take is to enable widespread testing of patients.  Many experts have cited the lack of access to a sufficient number of tests as a fundamental flaw in the response to the unfolding pandemic.  Yet, FDA has announced a new policy that will exacerbate this problem.

In recent weeks, the FDA has taken multiple steps to facilitate access to COVID-19 testing.  For example, the agency has issued Emergency Use Authorizations (EUAs) to over 30 molecular tests.  On March 16, FDA issued a policy that also allowed laboratories to begin offering laboratory-developed tests (LDTs) for 15 days prior to submission of an EUA and during the pendency of FDA’s review of the EUA.  (As readers of the blog know, we have long been critical of FDA’s limitations on LDTs, but the topic of LDTs and COVID-19 is for another day.)

In that same document, FDA also allowed companies to begin offering point of care serological tests without prior FDA review, provided that the test is validated, the test report includes certain required disclaimers, and the company has submitted a notification to FDA.  The combined effect of these and other steps has been to increase access to COVID-19 tests.

The point of care serological test policy, in particular, allowed companies to proceed to market quickly with easy-to-use IgG and IgM antibody tests, which provide information about exposure to COVID-19.  However, FDA has started instructing companies that their review of the notification is required prior to commencing distribution, and that review is taking one to two weeks.  This will likely lead to a delay in the availability of additional point of care serological tests.

In addition, FDA recently issued a statement that significantly curbs the ability of serological tests to play a meaningful role in addressing the COVID-19 pandemic.

Given their ease of use, serological tests generally do not need to be used in labs.  Instead, they can be used at the point of care, including doctors’ offices, urgent care centers, and drive-through testing centers, providing rapid information about COVID-19 status to the health care provider and patient.  Allowing tests at the point of care greatly facilitates patient access, as compared to having samples sent to a laboratory and then awaiting test results.

While FDA’s policy on March 16 addressed the FDA status of serological tests, it was silent about the status of these tests under the Clinical Laboratory Improvement Amendments (CLIA).  CLIA is a separate law that governs laboratory testing.  Among other elements, CLIA requires that tests be performed in appropriately certified laboratories, unless the test is categorized as “waived.”  High-complexity tests can only be performed in those laboratories that are certified as high-complexity, which is a small minority of labs in the U.S.

FDA announced its new policy on serological tests as a response to a Frequently Asked Question (FAQ) on its website (see FAQ webpage here).  In the FAQ response, FDA states:

While FDA has indicated that [tests offered prior to or without an EUA] may be appropriate for use in clinical laboratories and by healthcare workers at the point of care, the policies in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not provide a CLIA categorization and do not override any CLIA requirements.  Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.

This language may be opaque, but the impact is not: serological tests offered by manufacturers under the policy discussed above can only be performed in high-complexity laboratories.  In other words, these tests – which are designed to be used at the point of care – can only be run in facilities that hold high-complexity CLIA certifications.  Serological test samples could be collected at the point of care, but they would need to be transported to a high-complexity certified laboratory for testing, which defeats the purpose of a simple, rapid test.  The result is reduced access to most serological tests.

In a separate FAQ, FDA clarified that tests that have been authorized for point of care use via an EUA will be considered CLIA-waived and could be used in settings like doctors’ offices or drive-through testing sites (so long as these settings have CLIA certification to perform waived tests).  As of today, there are only three EUAs in which FDA has authorized point of care use (the Xpert Xpress SARS-CoV-2 Test, Accula SARS-CoV-2 Test, and ID NOW COVID-19 Test).

Bizarrely and inconsistently, yesterday the Department of Health and Human Services touted a new policy that ostensibly expanded testing by pharmacists.  The statement says, “In an effort to expand testing capabilities, we are authorizing licensed pharmacists to order and administer COVID-19 tests to their patients.  The accessibility and distribution of retail and independent community-based pharmacies make pharmacists the first point of contact with a healthcare professional for many Americans.  This will further expand testing for Americans, particularly our healthcare workers and first responders who are working around the clock to provide care, compassion and safety to others.”

The tests that pharmacists are most likely to offer, though, are point of care serological tests without EUAs, which means they are high-complexity tests under CLIA.  Unless local pharmacies and chain pharmacies are part of high-complexity CLIA-certified labs, under FDA’s FAQ, they will not be able “to order and administer COVID-19 tests to their patients.”  In other words, what HHS gave with one hand, FDA took away with the other.

We appreciate that FDA cannot simply ignore CLIA.  However, given that FDA and other parts of the government have waived multiple requirements during this National Emergency, it is striking that FDA’s current policy – and by extension HHS’ – is to block serological testing for COVID-19 in the locations where it is most needed and would be most helpful.

Ultimately, responsibility for this disjointed, uncoordinated policy rests with HHS, since FDA, CLIA, and the new policy on pharmacies all are under HHS’ purview.  In the past couple weeks, HHS has issued enforcement discretion policies for a number of issues in response to the COVID-19 pandemic, including the Federal Anti-Kickback Statute, telehealth, community-based testing sites, and HIPAA.  To avoid roadblocks to serological testing access, HHS should issue a similar enforcement discretion policy related to test complexity limitations under CLIA.