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Co-Diagnostics COVID-19 Test Independently Validated By US-based Distributor

September 3, 2020

NEW YORK, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Wellstand Health, LLC, a wholesale distribution and technology solutions company, announced the results of an independent validation study of Co-Diagnostics Logix Smart™ COVID-19 Test kit, a reverse transcriptase polymerase chain reaction (RT-PCR) test that uses samples swabbed from the nose, pharynx, or saliva.  The study tested 93 samples of COVID-19 and 93 samples of Influenza B, with results showing 100% sensitivity, 100% selectivity, and a Limit of Detection (LOD) of less than 1.2 viral genome copies per microliter (ul).

Wellstand Health identified the Logix Smart™ COVID-19 test as one of the most promising tests to address national and global testing needs. Its patented CoPrimer™ technology, which has demonstrated the ability to reduce amplification errors by a factor of 2.5 million, coupled with use of a single genetic target, makes it ideal for multiplexed solutions. In addition, the test is universal for most open-platform qPCR machines and other equipment. However, the test’s performance was challenged by certain outside parties. In response, TNG Dx contacted Co-Diagnostics, Inc. to offer its independent validation and assessment of the Logix Smart™ test.

Wellstand Health contracted Dr. Meghan Lockard, an independent consultant in New York City who has advised companies in the life sciences and health technologies, to validate the test’s metrics and help determine if the test could be used to develop a protocol for large scale, asymptomatic screening by increasing the existing test’s throughput 10-fold while reducing its cost commensurately. Dr. Lockard’s work confirmed the test’s performance characteristics and even found the LOD to be much lower than that outlined in the test’s submission to the FDA for emergency use authorization.  More importantly, Dr. Lockard’s protocol makes it feasible to support running millions of tests per day with accurate results even if patient samples have low viral loads.  

The results of Dr. Lockard’s findings will be published in a press release to follow in the coming days.  

Dr. Lockard commented, “At the beginning of the pandemic, we did not know anything about this novel virus.  We did not know that so many patients would be asymptomatic, or what viral loads would be pathologically relevant, a topic that is still surrounded by controversy.  It seems that Co-Diagnostics did the responsible thing and reported a very conservative level of detection in their FDA filing.”  1.2 copies per microliter was the lowest concentration Dr. Lockard assayed, and additional tests are currently underway to rigorously determine whether the LOD may even be lower.

Dr. Lockard further remarked, “The Logix Smart COVID-19 RT-PCR test performs well and I believe clinical testing programs should feel confident in its immediate adoption.  The test can also enable alterations in testing pipelines that fundamentally improve throughput and cost.”

She continues, “We will immediately begin working with outside labs to validate our findings for large-scale asymptomatic sampling. This test could be one of the key technologies to large-scale testing strategies where 99% or more of patient samples may be negative. A testing program like this is necessary to ensure public safety as we reopen businesses, schools, and public institutions.”

Co-Diagnostics reports to have the capacity to manufacture up to 3 million tests per week and thinking ahead, procured substantial inventory to meet the country’s needs.  The Company states that they have yet to be affected by supply chain issues.

About Dr. Meghan Lockard

Dr. Meghan A. Lockard earned her Ph.D. from the Rockefeller University in New York City, conducting her thesis in the laboratory of Dr. Cori Bargmann. In business, Dr. Lockard is an independent advisor specializing in early phase startups, small businesses, and non-profits in the life sciences and health tech space. She has advised companies on the development of a vaccine for fentanyl, soft robotic catheters to map atrial fibrillation, and AI for melanoma diagnosis, to name a few. Dr. Lockard teaches at Fordham University, Lincoln Center. She is on the editorial board for the journal Intelligence-Based Medicine, a scientific journal focused on applications of machine learning and AI in clinical practice. Prior, Dr. Lockard worked at Los Alamos National Laboratory's Advanced Measurement Science Group in the Bioscience Division, where she co-patented two inventions. Dr. Lockard is currently engaged as a science advisor for Wellstand Health.

About Wellstand Health, LLC

Wellstand Health, LLC is a wholesale distribution and technology solutions company formed to address unmet needs related to the Coronavirus pandemic. Wellstand Health combines leading scientific talent with sales and execution capabilities. Its partners have vast experience across numerous verticals, including Healthcare, Manufacturing, Food and Beverage, Aviation, Retail, Energy, Manufacturing, Retail, Financial Services, and Real Estate. Wellstand Health can be reached for comment at contact@texasnyg.com

About Co-Diagnostics, Inc.

Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a state-of-the-art diagnostics technology. The Company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

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