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SALT LAKE CITY - Co-Diagnostics , Inc. (NASDAQ:CODX), a molecular diagnostics company with a market capitalization of $22.51 million, has withdrawn its 510(k) application for the Co-Dx™ PCR COVID-19 Test following discussions with the U.S. Food and Drug Administration (FDA). The decision comes after the FDA provided feedback concerning the shelf-life stability of a test component. According to InvestingPro data, the company is currently trading at $0.70 per share, with analysts anticipating a sales decline in the current year.
The company had a constructive dialogue with the FDA and has opted to pursue an enhanced version of the test that addresses the regulatory concerns. Co-Dx has expressed satisfaction with the test’s clinical performance and intends to collect additional clinical evaluation data to support the new test’s application for 510(k) Over-The-Counter (OTC) clearance. InvestingPro analysis shows the company maintains a strong liquidity position with a current ratio of 6.92, though it’s currently experiencing rapid cash burn.
Co-Dx’s strategy is to further develop and commercialize its Co-Dx PCR platform, which includes ongoing innovations to the PCR Pro instrument. The updated COVID-19 test is part of a broader suite of diagnostics that Co-Dx plans to introduce, including tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.
The submission withdrawal allows Co-Dx to integrate recent developments from its PCR platform into the COVID-19 test, which the company believes will improve operational and manufacturing efficiencies. This includes consolidating manufacturing processes to use the next generation of test kits and instruments across all tests on the at-home and point-of-care platform.
The Co-Dx PCR platform, encompassing the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and associated tests and software, remains under review by the FDA and/or other regulatory bodies and is not yet available for sale.
This move aligns with Co-Diagnostics’ commitment to ensuring the highest quality and reliability of its diagnostic solutions. The company has not specified the timeline for the resubmission of the enhanced test for FDA clearance. The information regarding this development is based on a press release statement from Co-Diagnostics. For investors seeking deeper insights, InvestingPro offers comprehensive analysis with 8 additional ProTips and detailed financial metrics in its Pro Research Report, helping investors make informed decisions about companies like Co-Diagnostics that show unique market behavior with a beta of -0.64.
In other recent news, Co-Diagnostics, Inc. has received a notice of non-compliance from Nasdaq regarding its minimum bid price requirement. The company’s stock has been trading below the required $1.00 minimum bid price for the past 30 consecutive business days. Despite this notice, there is no immediate risk of delisting, as Co-Diagnostics has until July 9, 2025, to regain compliance. If the company fails to meet the requirement by the deadline, it may be granted an additional 180 days, provided it meets other listing standards. Co-Diagnostics is considering various options, including a reverse stock split, to address this issue. The company’s management has expressed its intent to closely monitor the stock’s closing bid price. This situation highlights the importance of regulatory compliance for maintaining investor confidence. The developments will be closely observed by investors and market participants.
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