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Developers anxious to get COVID-19 diagnostics to the public face a range of practical challenges. That was the feedback from diagnostics developers participating in a recent conference call conducted by the US Food and Drug Administration.

The 6 March town hall offered technical advice to labs that are developing molecular diagnostics to detect COVID-19, including tips on how to apply a recent guidance document, issued by US regulators, that allows companies to make their lab-developed tests (LDTs) available to health providers and hospitals under an Emergency Use Authorization (EUA) while awaiting FDA clearance.  (Also see "COVID-19: FDA Eases Approval Policy By Allowing LDT Use Under ‘Immediately In Effect’ Guidance" - Medtech Insight, 1 Mar, 2020.)

“This policy strikes the right balance so we can continue to ensure valid science prior to clinical testing and follow up with a critical independent check from the FDA, while quickly expanding test capabilities in the US,” Timothy Stenzel, director of the Office of Health Technology for In Vitro Diagnostics and Radiological Health in the FDA’s device center, said during the webinar.

Many of the questions during the webinar centered on a COVID-19 assay method developed by the Centers for Disease Control and Prevention (CDC), which was the first test to detect the virus to reach US patients. The CDC is allowing other sponsors to refer to its testing reference materials during the development process.

But, agency officials warned, these tests must hew as closely as possible to the CDC version to be covered under the same EUA. For example, developers can’t use substitute materials without FDA authorization, even though those used in the CDC test may not be readily available. And if a new COVID-19 test uses a different method to extract the virus from samples, the sponsor would need to provide a bridging study to show that the data is equivalent.

In addition to working with the FDA, sponsors should also communicate with state and local public health departments as early as possible during the test development process. That helps ensure both the departments’ test validation capability and the manufacturer’s compliance with state and local regulations, FDA officials said.

“It’s too early to speak about what happens after the EUA. But during previous outbreaks, there’s been no rush to pull tests from market.” – Timothy Stenzel

The agency is developing a template for rapid antibody testing and encouraged diagnostics developers to contact them with ideas or validation approaches for that. Similarly, the agency is looking at the possibility of nasal swab specimen collection that would allow potentially infected individuals to stay at home rather than risking additional exposure to others by going to health care facilities.

Alternate testing methods, such as imaging scans, have not yet been deemed effective for COVID-19 detection, but are still being explored, said Brittany Goldberg, a senior medical officer in the FDA’s Division for Microbiology Devices.

“We’re still learning more,” Goldberg said. “I have not seen CAT scans distinguishing between COVID and other lung infections, but we’ll see what happens.”

Because of the potential delays in bringing alternate tests to market, the FDA anticipates the EUA will stay in place for some time.

“It’s too early to speak about what happens after the EUA,” Stenzel said. “But during previous outbreaks, there’s been no rush to pull tests from market.”

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