Co-Diagnostics Reports Its Logix Smart Flu A/B/COVID-19 Test Approved For Sale In Mexico
Co-Diagnostics Reports Its Logix Smart Flu A/B/COVID-19 Test Approved For Sale In Mexico
Co-Diagnostics, Inc. (NASDAQ:CODX), a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced today that its Logix Smart™ Influenza A/Influenza B/COVID-19 "ABC" Test has been approved for sale in Mexico by the Mexican Department of Epidemiology ("InDRE") after InDRE successfully concluded an independent evaluation of the test's sensitivity and specificity for use as an RT-PCR multiplex test in that market.
InDRE, which is analogous to the U.S. Centers for Disease Control and Prevention (CDC), is required to evaluate any test used to detect COVID-19 before the test may gain clearance to be sold into the Mexican healthcare market.
INDRE類似於美國疾病控制和預防中心,在獲得銷售到墨西哥醫療市場的許可之前,需要對任何用於檢測新冠肺炎的測試進行評估。
Dwight Egan, CEO of Co-Diagnostics, commented "Since being granted its CE marking last year, we have seen demand increase for our high-quality ABC multiplex diagnostic. We expect that the ability to accurately and reliably differentiate between influenza A/B and COVID-19 will grow in importance after predictions by experts like the CDC that reduced population immunity due to lack of flu virus activity last year may now result in a severe flu season.
Co-Diagnostics首席執行官德懷特·伊根(Dwight Egan)評論説:“自從去年獲得CE認證以來,我們看到對我們高質量的ABC多路診斷的需求有所增加。我們預計,在A型流感/B型流感和新冠肺炎流感之間準確和可靠地區分開來的能力將變得更加重要。預測美國疾病控制與預防中心等專家表示,去年由於流感病毒活動不足,人羣免疫力下降,現在可能會導致嚴重的流感季節。
"We believe that the Mexican approval and clearance in such an important healthcare market serves as further validation of the quality of our CoPrimer™ platform, and our commitment to increasing access to affordable, state-of-the-art diagnostics products around the world."
我們相信,墨西哥在這樣一個重要的醫療保健市場上的批准和批准進一步證實了我們的CoPrimer™平台的質量,以及我們在世界各地增加獲得負擔得起的最先進診斷產品的承諾。“
譯文內容由第三人軟體翻譯。