The company’s decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test related to shelf-life stability.

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Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit an enhanced version of the test to address the matter raised in the 510(k) review process. 

After collecting clinical evaluation data to support the new test’s performance, the company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance.

A new submission also allows the company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will help create greater operational and manufacturing efficiencies. For example, it could consolidate manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform.

The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.

Price Action: CODX stock is down 14.9% at $0.60 during the premarket session on last check Monday.

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