Co-Diagnostics Inc. Achieves CE-Mark Regulatory Clearance for Logix Smart® ZDC Test, Enabling European Market Access for Zika, Dengue, and Chikungunya Diagnostics

Reuters

Sep 11

Co-Diagnostics Inc. Achieves CE-Mark Regulatory Clearance for Logix Smart® ZDC Test, Enabling European Market Access for Zika, Dengue, and Chikungunya Diagnostics

Co-Diagnostics Inc., a molecular diagnostics company, announced a significant milestone in regulatory approval for its Logix Smart® ZDC Test. The test, which received CE-marking regulatory clearance in 2019, is designed to detect and differentiate Zika, dengue, and chikungunya viruses using the company's patented Co-Primers technology. This approval allows the test to be marketed as an in vitro diagnostic in regions accepting CE-marking, pending local registration. Additionally, Co-Diagnostics' Indian joint venture, CoSara Diagnostics Pvt Ltd, received clearance in October 2021 to manufacture and sell the SaraGene™ Dengue and Chikungunya Multiplex RT-PCR test in India. These advancements underscore the company's progress in expanding its diagnostic solutions globally.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Co-Diagnostics Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA70813) on September 11, 2025, and is solely responsible for the information contained therein.

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

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Achieves CE-Mark Regulatory Clearance for Logix Smart® ZDC Test, Enabling European Market Access for Zika, Dengue, and Chikungunya Diagnostics","media":"Reuters","content":"<html xmlns=\"http://www.w3.org/1999/xhtml\" xmlns:newsg2=\"http://iptc.org/std/nar/2006-10-01/\" xmlns:xhtml=\"http://www.w3.org/1999/xhtml\"><head><title>\n      Co-Diagnostics Inc. Achieves CE-Mark Regulatory Clearance for Logix Smart® ZDC Test, Enabling European Market Access for Zika, Dengue, and Chikungunya Diagnostics\n    </title></head><body><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n        Co-Diagnostics Inc., a molecular diagnostics company, announced a significant milestone in regulatory approval for its Logix Smart® ZDC Test. The test, which received CE-marking regulatory clearance in 2019, is designed to detect and differentiate Zika, dengue, and chikungunya viruses using the company's patented Co-Primers technology. 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Achieves CE-Mark Regulatory Clearance for Logix Smart ZDC Test, Enabling European Market Access for Zika, Dengue, and Chikungunya Diagnostics. Co-Diagnostics Inc., a molecular diagnostics company, announced a significant milestone in regulatory approval for its Logix Smart ZDC Test. The test, which received CE-marking regulatory clearance in 2019, is designed to detect and differentiate Zika, dengue, and chikungunya viruses using the company's patented Co-Primers technology. This approval allows the test to be marketed as an in vitro diagnostic in regions accepting CE-marking, pending local registration. Additionally, Co-Diagnostics' Indian joint venture, CoSara Diagnostics Pvt Ltd, received clearance in October 2021 to manufacture and sell the SaraGene Dengue and Chikungunya Multiplex RT-PCR test in India. 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