NEW YORK, NY / ACCESSWIRE / March 13, 2019 / Co-Diagnostics, Inc., (NASDAQ: CODX), expects to immediately begin commercializing their newly-CE marked test for Zika, dengue and chikunguna, according to news released last week.
The Co-Diagnostics release announced that their new Logix Smart ZDC test meets the essential requirements of the European Community's In-Vitro Diagnostic Medical Device Directive, allowing immediate export and sales of the product to markets that accept a CE mark as valid IVD regulatory approval, with the expectation that additional sales and distribution opportunities will be created following the granting of this approval across their target markets. These include several countries south of the US border in which they already have distribution agreements in place, and where local product registration requirements may already be pending.
Last week's announcement stated that the design, development, and validation of test was completed from start to finish in under 6 months, including the entire regulatory approval process. Taking a test from concept to commercialization in that amount of time certainly underscores their mission to applying their own platform for efficient, economical product development.
This multiplex test that identifies several targets at once also appears to be the most sophisticated of all Co-Diagnostics products approved for regulatory approval to date. Company CEO described this ''highly-specific diagnostic for three harmful diseases at once'' as being made possible thanks to the company's ''patented CoPrimer design platform enabling a massive reduction in false positives, which is especially important - but notoriously more difficult - in multiplexed assays of related pathogens.''
With the approval of this test, the company has released three products with CE markings since July 2018. If their infectious disease pipeline and sales prospects continue at this rate, their fundamentals alone will soon make the $2 price target set by H.C. Wainwright (whose analyst recently initiated coverage of CODX with a Buy rating) seem conservative.
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SOURCE: Co-Diagnostics, Inc.