Co-Diagnostics Withdraws FDA Application for Covid Test

Dow Jones

Feb 22, 2025

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)

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Co-Diagnostics is seeking 501(k) review, which looks at whether a device is safe and effective. \n\n\n  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. \n\n\n  The company aims to collect clinical evaluation data on a new test's performance before submitting it. \n\n\n \n\n\n  Write to Katherine Hamilton at katherine.hamilton@wsj.com \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  February 21, 2025 16:32 ET (21:32 GMT)\n\n\n  Copyright (c) 2025 Dow Jones & Company, Inc.","kind":"highlight","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"-1","news_tag":"policyRegulatory","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":true,"code":"91000000","status":"200"}}}