Welcome to our dedicated page for Co-Diagnostics news (Ticker: CODX), a resource for investors and traders seeking the latest updates and insights on Co-Diagnostics stock.
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) has completed the principal design for a PCR test targeting mutations in the new SARS-CoV-2 variant, VUI 202012/01. This strain exhibits several mutations and may be more transmissible. The company's CoPrimer platform is noted for its accuracy in distinguishing similar genetic sequences, reducing false positives. Co-Diagnostics emphasizes that the new test will be a distinct product and that existing COVID-19 diagnostics should remain unaffected. CEO Dwight Egan highlighted the rapid development capabilities of their technology.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced the sale of over 10 million Logix Smart™ COVID-19 Test Kits to laboratories and distributors worldwide. The company anticipates strong Q4 revenue exceeding Q3 2020 figures, highlighting the effectiveness of its business model. CEO Dwight Egan emphasized the company's commitment to providing high-quality diagnostics, including tests for influenza and multiplex tests in its portfolio. Additionally, Co-Diagnostics' joint venture in India received CDSCO clearance for various RT-PCR tests, expanding its reach in the diagnostics market.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced that its joint venture, CoSara Diagnostics Pvt Ltd, received clearance from India's Central Drugs Standard Control Organization to manufacture and sell the Saragene™ COVID-19 2-gene multiplex RT-PCR test. This in vitro diagnostic test targets the SARS-CoV-2 virus using patented CoPrimer™ technology and is designed to meet multi-target diagnostic needs. The test will support India's efforts to manage COVID-19 testing and aligns with World Health Organization guidelines.
Co-Diagnostics, Inc. (Nasdaq: CODX) has announced regulatory authorization for its Logix Smart™ ABC test for Influenza A/B and the Logix Smart™ SARS-CoV-2 multiplex test, allowing sales in CE-marking markets. These tests enable simultaneous detection of influenza and COVID-19, addressing the need for accurate diagnostics amid overlapping symptoms. The company's CoPrimer™ technology enhances test specificity, reducing false positives. The CE markings facilitate immediate export and sales in the European Community and other global markets.
Co-Diagnostics, Inc. (CODX) reported strong Q3 2020 results with revenues of $21.8 million and a net income of $15.7 million, equating to $0.53 per diluted share. YTD net income reached $29.7 million. The company received CE markings for two key products: the Logix Smart ABC test and the SARS-CoV-2 multiplex test. A substantial increase in stockholders' equity to $52.7 million from $1.7 million at the year's start was noted. CoSara Diagnostics reported $3.0 million in Q3 revenue, a threefold increase from Q2.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced that their CoPrimer™ platform can detect SARS-CoV-2 directly from saliva samples without RNA extraction. The company’s whitepaper highlights the technology's efficiency in providing rapid and cost-effective COVID-19 testing. CEO Dwight Egan emphasized the market potential for extraction-free tests, indicating plans to integrate these into their offerings. The recent collaboration with Clinical Reference Laboratory (CRL) will enhance consumer access to their saliva-based tests, further positioning CODX as a leader in molecular diagnostics.
Co-Diagnostics, Inc. (Nasdaq: CODX) announced it will release its third quarter 2020 earnings on November 16, 2020, after market close. An earnings call will be hosted at 4:30 PM EDT, featuring prepared remarks from CEO Dwight Egan and a Q&A session for analysts. The call will be recorded and later accessible on the company's website. Co-Diagnostics focuses on developing innovative molecular diagnostics technology and utilizes its proprietary methods to create tests for various industries, including infectious diseases.
Co-Diagnostics, Inc. (Nasdaq: CODX) is set to amend its Q2 2020 Form 10-Q due to an incorrectly recorded expense. This amendment will reflect an increase in basic and diluted net income per share to $0.51, up from a previously reported $0.08. The amended report is expected to be filed before the Q3 2020 Quarterly Report. The company focuses on the development of molecular diagnostic tests utilizing its proprietary technology.
Co-Diagnostics (Nasdaq: CODX) announced that Access Genetics' OralDNA Labs received an amended Emergency Use Authorization (EUA) for a COVID-19 RT-PCR test, utilizing Co-Diagnostics' Logix Smart™ COVID-19 kit. This test allows for a saline oral rinse collection, which could enhance testing comfort and accessibility. CEO Dwight Egan noted that this represents the first FDA authorization for a test using oral rinse technology, underscoring the adaptability of the company's CoPrimer™ platform. The announcement highlights the potential for improved community testing.
Co-Diagnostics (NASDAQ: CODX) announced that its Logix Smart™ ABC Test for Influenza A, Influenza B, and COVID-19 is set to launch for US CLIA laboratory customers in early October 2020. The test utilizes the patented CoPrimer™ technology designed to minimize false positives in PCR tests, addressing the critical need for accurate viral detection amidst the ongoing pandemic. The initial release will be for laboratory-developed tests while the company seeks FDA Emergency Use Authorization and CE marking registration.
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