NEW YORK (GenomeWeb) — Co-Diagnostics announced today that its Logix Smart Zika screening test has received CE-IVD marking, permitting its sale in the EU and other areas that recognize the designation.
The PCR-based test is designed to detect the presence or absence of the Zika virus in serum or plasma collected alongside urine from patients with suspected infection. It will be manufactured at the Salt Lake City, Utah-based firm's ISO 13485:2016-certified facility.
Co-Diagnostics noted that it does not intend to seek US Food and Drug Administration clearance for the test due to the low domestic rate of Zika incidents.
Earlier this year, the company received CE-IVD marking for its Logix Smart tuberculosis test. It is also developing a test to identify and distinguish between Zika, dengue fever, and chikungunya infection.