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Co-Diagnostics, Inc. (NASDAQ: CODX) is a pioneering molecular diagnostics company based in Sandy, Utah. The company is renowned for its unique, patented technology that significantly enhances the speed, performance, and cost-efficiency of DNA testing for a variety of diseases compared to traditional methods. Co-Diagnostics focuses on the development, manufacturing, and commercialization of its proprietary technologies through sales, development, and licensing agreements.
Co-Diagnostics’ core technology is protected by multiple patents and trade secrets, enabling revolutionary approaches in molecular diagnostics. These innovations have been utilized to develop a range of assays in the infectious disease sector, demonstrating the technology's exceptional capabilities. The company's patented inventions stem from advanced mathematical models designed by Dr. Brent C. Satterfield.
The firm’s product portfolio includes diagnostic tests for diseases such as tuberculosis, Zika, hepatitis B and C, malaria, dengue, and HIV. These tests utilize the detection and analysis of nucleic acid molecules (DNA or RNA) to provide accurate and efficient diagnostics. Co-Diagnostics also leverages its proprietary technology to create tests for its Co-Dx PCR platform, which includes at-home and point-of-care solutions.
One of the notable collaborations of Co-Diagnostics is its joint venture with CoSara Diagnostics Pvt Ltd in India. This partnership has led to regulatory clearance from India’s Central Drugs Standard Control Organization (CDSCO) for multiple diagnostic tests, including the SARAPLEX™ Influenza Multiplex (IFM) Test Kit, which differentiates between Influenza A and B strains.
Recently, Co-Diagnostics announced significant milestones, such as the opening of new manufacturing facilities in Salt Lake City, Utah, and Ranoli, India. These facilities will enhance the production of the company’s novel Co-Dx PCR Pro™ instrument and test cups, as well as the Co-Primers™ chemistry that is vital for its PCR diagnostic tests. The Salt Lake City facility, inaugurated with support from local dignitaries and business leaders, marks a critical step in expanding the company's production capabilities.
The company’s forward-looking strategies include submitting an Emergency Use Authorization (EUA) to the FDA for the Co-Dx PCR Pro™ instrument, mobile app, and COVID-19 test. This submission is part of Co-Diagnostics’ effort to decentralize PCR diagnostics and extend its reach to at-home and point-of-care settings. The company is also developing tests for tuberculosis, multiplex respiratory infections, and HPV, among others.
Co-Diagnostics’ financial performance and strategic initiatives are regularly discussed through conference calls and webcasts, involving key executives such as CEO Dwight Egan and CFO Brian Brown. The company remains committed to innovation and growth, aiming to provide accessible and high-quality diagnostic solutions worldwide.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced that its joint venture, CoSara Diagnostics Pvt Ltd, received approval from India's CDSCO to manufacture and sell the Saragene™ Dengue and Chikungunya Multiplex RT-PCR test as an in vitro diagnostic. This milestone is significant as it represents the 10th assay approved by the CDSCO for CoSara. The multiplex test enhances the company's portfolio designed to address public health needs in India, where dengue and chikungunya pose significant health risks. The approval reflects the company's commitment to innovation in molecular diagnostics.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) announced the introduction of its at-home and point-of-care PCR device at the 2021 AACC Annual Scientific Meeting in Atlanta, GA, from September 26-30. The press conference is scheduled for September 28 at 1:00 PM ET, where details on the PCR Platform and other updates will be shared. Co-Diagnostics will also showcase its diagnostic products at booth #2454. Notably, the new device has not yet been reviewed by the U.S. FDA and is not currently available for sale.
Co-Diagnostics (Nasdaq: CODX) announced a corporate rebranding following significant growth, aiming to reflect its expanded mission and entry into new diagnostics sectors. The company, known for its Logix Smart™ COVID-19 Test, has successfully sold over 22 million tests globally. They are developing an innovative at-home and point-of-care PCR testing platform that promises rapid results. The rebranding includes a new logo and marketing materials, anticipated to launch as they optimize their new device for FDA review. This change aims to enhance broad access to quality diagnostic solutions.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) will present at the 5th Advances in Circulating Tumor Cells (ACTC) conference in Kalamata, Greece, from September 22-25, 2021. The presentation is scheduled for September 23 at 14:50 local time. The Company's Logix Smart™ COVID-19 Tests will be used for on-site testing of attendees, highlighting its expanding presence in Europe. Co-Diagnostics aims to engage with both new and existing customers to showcase its diagnostic products. Interested European distributors and laboratories can contact the Company for more information.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced 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). This clearance follows a successful independent evaluation of the test's sensitivity and specificity. Following the CE marking, demand has surged for the ABC multiplex diagnostic, particularly as flu season approaches amidst reduced immunity predictions. The company views this approval as validation of its CoPrimer™ platform and a step toward enhancing access to affordable diagnostics.
Co-Diagnostics, Inc. (NASDAQ: CODX) will present at the Sidoti Fall Virtual Investor Conference on September 23, 2021, at 3:15 p.m. EDT. The presentation will be led by CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson. Investors can access the event through the Co-Diagnostics website. Registration for the presentation and one-on-one meetings is available at www.sidoti.com/events.
Co-Diagnostics (Nasdaq: CODX) announced that its joint venture, CoSara Diagnostics, received clearance from India's CDSCO to manufacture and sell Saragene™ dengue and chikungunya RT-PCR tests as in vitro diagnostics. Utilizing Co-Diagnostics' patented CoPrimer™ technology, these tests aim to accurately detect these mosquito-borne viruses, addressing a significant public health issue as the incidence of dengue has dramatically increased globally. CEO Dwight Egan emphasized the importance of accurate diagnosis for effective treatment and highlighted CoSara's prior approvals for various tests in India.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) announced today that CEO Dwight Egan will join a panel discussion titled "How We Can Defeat the Next Pandemic," hosted by Scott Gottlieb, M.D., at the H.C. Wainwright & Co. 2021 Global Investor Conference. This virtual event is scheduled for September 15, 2021, at 12:00 pm ET. Attendees can register for the conference here. Additionally, Mr. Egan and CFO Brian Brown will present a Healthcare & Biotech On-Demand session available starting September 13, 2021, at 7:00 am ET on their website.
Co-Diagnostics (Nasdaq: CODX) announced that its Logix Smart™ COVID-19 Test Kit was utilized by Italian researchers to detect SARS-CoV-2, including mutated strains, through community surveillance testing of discarded saliva samples. The peer-reviewed results were published in Science of the Total Environment. The study involved testing items like plastic cups and bottles across 20 sites in Northern Italy during the COVID-19 peak in early 2021. CEO Dwight Egan emphasized the importance of this study, highlighting the test's effectiveness in identifying viral presence in environmental samples.
Co-Diagnostics, Inc. (Nasdaq-CM: CODX) will showcase its innovations at the 13th Annual Next Generation Dx Summit from August 24-26, 2021, in Washington, D.C. The summit focuses on critical issues in diagnostics, featuring streams on Point-of-Care Testing (POCT) and Liquid Biopsy. CEO Dwight Egan is scheduled to present on August 25 at 10:30 am ET, discussing a rapid PCR diagnostics platform designed for POCT applications that aim to streamline testing protocols across various environments. More information on the summit can be found at Next Generation Dx.