Co-Diagnostics (CODX) said Friday it has withdrawn its application to the US Food and Drug Administration for its Co-Dx PCR COVID-19 test in favor of filing an enhanced test version for clearance.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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