28th June 2021 Product update: rapidvirology staff writer
CE-Marking for Extraction-Free Direct Saliva SARS-CoV-2 Test
Co-Diagnostics, Inc. has announced that its Logix Smart™ SARS-CoV-2 DS (Direct Saliva) has obtained regulatory authorization to be sold as an in vitro diagnostic ("IVD") for the diagnosis of COVID-19 in markets that accept CE markings, and is now available for purchase from the Company's Utah-based ISO-13485:2016 certified facility.
Co-Diagnostics' Logix Smart DS test kit is designed to detect the presence of the RdRp and E genes of SARS-CoV-2 directly from minimally processed human saliva samples while eliminating RNA extraction of the samples, a costly and time-consuming process required by most PCR tests. Co-Diagnostics believes that eliminating the extraction process has the potential to increase throughput and lower costs of not only COVID-19 testing but also any other pathogen for which the Company develops a direct saliva test.
Dwight Egan, Chief Executive Officer of Co-Diagnostics, commented, "We are pleased to announce that this new, simplified PCR testing method is now available as an IVD in any country that accepts a CE marking as valid regulatory approval to aid in the ongoing battle against the COVID-19 pandemic, which we anticipate will drive demand for diagnostics as normalization testing protocols are established. We believe that the need for testing will especially persist in countries where vaccination rates lag substantially behind those of the United States.
"The direct saliva technical advance represents one of the important innovations that the Company has developed since the pandemic began. Our unique CoPrimer™ technology utilized in this test design received initial patent protection in 2018, which was further strengthened by an additional patent last year. In combination with this technology, direct saliva testing will play a key role in our ongoing centralized lab initiative, as well as our forthcoming at-home and point of care testing strategies. As a Company, we are particularly pleased with the dedication and hard work performed by our scientific, laboratory, and regulatory staff that has culminated in this significant achievement.
"The quality of our tests and technology have been consistently borne out both here in the United States and in over 50 countries internationally as Co-Diagnostics has been chosen by prestigious laboratories who specialize in providing highly accurate PCR testing. We believe this CE marking is a critical indicator of our goal to bring high quality, affordable molecular diagnostics to nations across the world, where our distributors and customers have come to depend on the quality, accuracy, and affordability of our diagnostic products, and of our commitment since the earliest days of the pandemic to remain on the forefront of the fight against COVID-19."
The CE Marking for the Logix Smart DS CE-IVD Test confirms that it meets the Essential Requirements of the European Community's In-Vitro Diagnostic Medical Device Directive (IVDD 98/79/EC), permitting export and sales of the product as an IVD to commence immediately in the European Community. Many other global markets also accept a CE marking as valid regulatory approval following routine local product registration, which allows sales of the Company's IVD into these areas as well.
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Date Published: 28th June 2021
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Note: This content has been edited by a rapidvirology.com staff writer for style and content.