Co-Diagnostics Completes Submission of CE Mark Registration for Tuberculosis Screening Test
Company’s Logix Smart™ MTB Test to be available for purchase with
CE mark in
The technical file dossier includes a description of the test to support conformance to the CE marking standards, which will confirm that the test meets the Essential Requirements of the European Community’s In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC). The registration process is expected to be complete by the end of July, at which point sales of the product may commence as an IVD with the CE marking included. The Logix Smart MTB Test detects DNA of mycobacteria tuberculosis (MTB) complex members and functions via real-time polymerase chain reaction (PCR) to detect and amplify the IS6110 and MPB64 regions of the MTB genome.
Symptoms of tuberculosis may be mild or non-existent early on, and many affected people seek a diagnosis too late after the disease has advanced, which is then more difficult to treat and more likely to be fatal. In some regions, cost prohibits residents from seeking a tuberculosis diagnosis.
Mr. Egan continued, “The key component to battling tuberculosis is an
early, accurate, and affordable diagnosis. We are confident that the
time we have taken to ensure this test meets our high standards of
quality and performance will allow us to better meet the global demand
for detection of a disease with 99.9% of infections occurring outside of
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.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