The US Food and Drug Administration (FDA) has issued an updated guidance (March 16, 2020) to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers to achieve more rapid and widespread testing capacity in the US. Roche, Thermo Fisher Scientific and Abbott are among several companies receiving Emergency Use Authorization from the FDA for their diagnostics tests for COVID-19.

FDA issues updated guidance on COVID-19 diagnostics

The FDA issued an updated guidance (March 16, 2020) to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers to achieve more rapid and widespread testing capacity in the US.

The FDA’s original guidance for developing COVID-19 diagnostic policy was applicable only to laboratories that were certified to perform high-complexity testing consistent with requirements under the Clinical Laboratory Improvement Amendments (CLIA). Under its updated guidance, the agency does not intend to object to commercial manufacturers distributing and labs using new commercially developed tests prior to the FDA granting an Emergency Use Authorization (EUA), under certain circumstances. EUA authority allows FDA to facilitate the availability and use of medical countermeasures needed during public health emergencies.

The FDA said that it is aware that numerous commercial manufacturers are developing tests for coronavirus with the intention of submitting an EUA to the FDA. Due to the public health emergency, the FDA says it does not intend to object to the distribution and use of these tests for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. As noted in the guidance, the FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated by the manufacturer.

The updated policy also provides recommendations for test developers who may wish to develop serological tests for use during this coronavirus outbreak. Serological tests measure the amount of antibodies or proteins present in the blood when the body is responding to a specific infection.

The FDA says that while it recognizes that serology tests are less complex than molecular tests and are solely used to identify antibodies, which limits their effectiveness for diagnosis, it does not intend to object to the distribution and use of serology tests to identify antibodies to SARS-CoV-2 where the test has been validated, notification is provided to the FDA, and warning statements are included with the tests, for example, noting the test has not been reviewed by the FDA and results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

The updated guidance also puts in place a policy for states to take responsibility for tests developed and used by laboratories in their states, similar to the action the FDA granted to the New York State Department of Health. States can set up a system in which they take responsibility for authorizing such tests and the laboratories will not engage with the FDA.

Since the beginning of the novel coronavirus outbreak in January 2020, the FDA says (as of March 16, 2020) that more than100 test developers have sought FDA guidance with the development and validation of tests they plan to bring through the EUA process. Additionally, the FDA says that more than 40 laboratories have notified it that they are testing or intend to begin testing soon (as of March 16, 2020) under the FDA’s new policy for laboratory-developed tests for COVID-19.

Roche, Thermo Fisher, Abbott Gain Authorization for COVID Diagnostic Tests

Several companies, including Roche, Thermo Fisher, and Abbott have received Emergency Use Authorization (EUA) from the FDA for the diagnostic tests for COVID-19.

Roche has received EUA from the FDA for its cobas SARS-CoV-2 test, which is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease. The test applies is used in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria for testing. Hospitals and reference laboratories can run the test on Roche’s automated cobas 6800 and cobas 8800 Systems, which are available in the US and globally.

Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 test, provide test results in three and half hours. Upon authorization, Roche says it will have millions of tests a month available for use on the cobas 6800 and 8800 systems.

The CE-IVD test is also available in markets accepting the CE mark (a certification mark that indicates conformity with health, safety, and environmental protection standards for products sold within the European Economic Area) for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.

Thermo Fisher Scientific reported on March 13, 2020 that it had received EUA for its diagnostic test that can be used by Clinical Laboratory Improvement Amendments (CLIA) high-complexity laboratories in the US to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19, and not for any other viruses or pathogens. The authorized test uses Applied Biosystems TaqPath Assay technology and is designed to provide patient results within four hours of a sample being received by a lab. The estimated time-to-result also includes time for sample preparation and instrument analysis.

Thermo Fisher also provided an update (as of March 16, 2020) on its anticipated production rate. The company currently has 1.5 million tests available to ship under the EUA label and expects to quickly ramp up to reach 2 million tests per week. Based on availability of raw materials and an installed instrument base, the company expects to scale production up to 5 million tests per week during the month of April. The available tests will initially be distributed to approximately 200 labs in the US and Thermo Fisher says it will continue to work in partnership with government agencies and private partners to expand access.

The EUA test is optimized for use on the company’s Applied Biosystems 7500 Fast Dx Real-time PCR instrument, which is covered under the EUA and already used in clinical laboratories worldwide.

Also, Abbott has received an EUA from the FDA for its molecular test for COVID-19. The company says it is immediately (as of March 18, 2020) shipping 150,000 Abbott RealTime SARS-CoV-2 EUA tests to existing customers in the US. The tests are used on the company’s m2000 RealTime System. Abbott says it will be working with health systems and government authorities to deploy additional m2000 systems where they are needed.

The FDA also granted EUA to Hologic for its Panther Fusion SARS-COV-2 Assay, and Laboratory Corporation of America (LabCorp) for its COVID-19 RT-PCR test.

Source:  FDA (guidance), FDA (Thermo Fisher Scientific), FDA (Holigic and LabCorp), Thermo Fisher Scientific, Roche, and Abbott