By Katherine Hamilton
Co-Diagnostics withdrew its application to the Food and Drug Administration for a Covid-19 test.
The Salt Lake City diagnostics company said Friday it plans to submit an enhanced version of the test, known as Co-Dx PCR COVID-19 Test. Co-Diagnostics is seeking 501(k) review, which looks at whether a device is safe and effective.
The decision to withdraw is based on discussions Co-Diagnostics had with the FDA about the ability to detect a potential deterioration of one component of the test, related to shelf-life stability, it said. Co-Diagnostics plans to address the issue before re-submitting, it said.
The company aims to collect clinical evaluation data on a new test's performance before submitting it.
Write to Katherine Hamilton at katherine.hamilton@wsj.com
(END) Dow Jones Newswires
February 21, 2025 16:32 ET (21:32 GMT)
Copyright (c) 2025 Dow Jones & Company, Inc.
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