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Co-Diagnostics Plans to Seek FDA Clearance for Enhanced Version of COVID-19 Test
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Co-Diagnostics Plans to Seek FDA Clearance for Enhanced Version of COVID-19 Test
Feb 21, 2025 2:00 PM

04:42 PM EST, 02/21/2025 (MT Newswires) -- Co-Diagnostics ( CODX ) said Friday it has withdrawn its application to the US Food and Drug Administration for its Co-Dx PCR COVID-19 test in favor of filing an enhanced test version for clearance.

The decision followed talks with the FDA over "the ability to detect a potential deterioration of one component of the test, related to shelf-life stability," the company said.

"Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the...review process," the firm said.

The shares were rising past 5% in after-hours activity.

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