FDA Signals Flexibility with COVID-19 Tests

A bipartisan group of experts in economics, health, technology, and ethics recommended that the U.S. scale up COVID-19 testing—5 million per day by June, 20 million per day by midsummer—in order to fully re-mobilize the economy.

Consistent with this, FDA has taken various steps to accelerate the availability of testing, as we have previously reported. Notably, in its Policy for Diagnostic Tests for Coronavirus Disease-2019 (last updated May 11), FDA describes circumstances under which CLIA-certified laboratories that develop and validate tests for coronavirus can use the tests before the agency has completed review of the lab’s EUA. 

But this policy does not apply to at-home tests, a caveat we analyzed here. In March, FDA warned that it had “not authorized any test” for at-home use, noting that the public health value of expanded COVID-19 testing is predicated on testing that is “safe and accurate.” This statement halted a cadre of startups that were gearing to launch such tests, such as Carbon Health, Nurx, and Everlywell.

Now, a couple of months later, FDA has signaled more openness to a variety of tests—those being (a) collected at home, (b) performed at point of care, and (c) used for asymptomatic patients. 

At-Home Tests

A patient hoping to take a COVID-19 test from the comfort of home—and thereby minimize the need for PPE—has at least three options. The first is manufactured by LabCorp. FDA re-issued an EUA to LabCorp to permit testing of samples collected by patients using a designated kit containing nasal swabs and saline. This was the first test approved for home collection; we shared the development here.

The second test approved for home collection is by Rutgers. Rutgers’ test is the only one authorized to use saliva samples to test for SARS-CoV-2, the strain of coronavirus that causes COVID-19. This saliva-based test is arguably less invasive than the nasal swab alternative.

The latest test to receive an EUA for home collection is from Everlywell—the same company that announced launch plans back in March. Everlywell’s test is first-of-its-kind in a third way: it is the first standalone at-home sample collection kit. In other words, the kit can work with multiple tests at multiple labs.

The points of distinction among these tests are summarized below:

Manufacturer

Sample Type

Test Type

LabCorp

Nasal

PCR Test (molecular)

Rutgers

Saliva

PCR Test (molecular)

Everlywell

Nasal

For use only with

IVD Tests (molecular)

 

All three EUAs, however, still require that the nasal or saliva sample be sent to a CLIA-certified lab for processing. The emergency authorization should not be construed as a general authorization to fully test oneself at home, without lab involvement. 

Furthermore, all three tests require a doctor’s order. The Everlywell kit, for example, may be used by individuals who have been screened using an online questionnaire reviewed by a healthcare provider. 

CLIA-Waived Tests (Point of Patient Care)

In another major step, FDA has approved at least four CLIA-waived tests. This means the tests can be performed at the point of patient care. They may be relatively more straightforward or otherwise less risky than other diagnostic tests. These tests include:

  1. Quidel’s antigen test;
  2. Abbott’s ID NOW molecular test;
  3. Mesa Biotech’s molecular test; and
  4. Cepheid’s molecular test.

Furthermore, Quidel’s EUA is the first for an antigen test—a new category of tests that detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. In contrast, molecular tests for viral RNA, typically PCR tests, received FDA’s earliest stamp of approval.

Tests for Asymptomatic Patients

FDA has also, for the first time, finally authorized a test that is intended for use by individuals without symptoms. The test, manufactured by Hologic, is the first for asymptomatic patients but the second for the firm, which was among the first handful of firms to receive an EUA for COVID-19.

For a complete list of COVID-19 tests that have received an EUA from FDA in light of the Public Health Emergency, please see its website

The Morrison & Foerster COVID-19 Task Force will continue to provide updates to consumer‑facing product manufacturers as FDA issues new guidance. Follow our Life Sciences and Product Liability blogs to stay informed.