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

Reuters

09/11

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.

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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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