Co-Diagnostics, Inc. Receives CE Mark for Zika Screening Test
Company’s Logix Smart™
The CE mark confirms that the test meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), allowing sales of the product to commence as an IVD with the CE marking included. The Logix Smart Zika Test uses polymerase chain reaction (“PCR”) technology to detect the presence or absence of the Zika virus in serum, plasma, collected alongside with urine, from patients suspected to be infected. While not lethal itself, studies have directly linked Zika with cases of microcephaly, a neurological disease that affects the brain development of fetuses. The WHO has raised the priority for R&D investments for Zika in their 2018 annual review of diseases.
Mr. Egan continued, “Co-Diagnostics’ patented CoPrimer™ design platform, on which this test is built, has been shown to drastically reduce the occurrence of ‘primer-dimers,’ the often-occurring phenomenon that leads to false positives in PCR diagnostics. The groundbreaking multiplexing capabilities of CoPrimers is also being used to facilitate the development of another diagnostic test to identify and distinguish between Zika, dengue fever, and chikungunyua, three diseases with a high degree of comorbidity in regions where they are prevalent. We have already seen very promising verification results for this multiplexed screening test and look forward to being able to announce news related to its regulatory clearance in the near future, further augmenting our Company’s molecular diagnostics product offerings in underserved markets of the world.”
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as "believes," "expects," "estimates," "intends," "may," "plans," "will" and similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions.Forward-looking statements in this release include statements regarding the (i) use of funding proceeds, (ii) expansion of product distribution, (iii) acceleration of initiatives in liquid biopsy and SNP detection, (iv) use of the Company’s liquid biopsy tests by laboratories, (v) capital resources and runway needed to advance the Company’s products and markets, (vi) increased sales in the near-term, (vii) flexibility in managing the Company’s balance sheet, (viii) anticipation of business expansion, and (ix) benefits in research and worldwide accessibility of the CoPrimer technology and its cost-saving and scientific advantages. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances.Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.
Co-Diagnostics Investor Relations
Lytham Partners, LLC
Joe Diaz, Robert Blum and Joe Dorame