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Co-Diagnostics, Inc. - CODX STOCK NEWS

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.

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Co-Diagnostics (CODX), a molecular diagnostics company, announced the extension of its vector control customer base to 25 customers across 15 U.S. states. The expansion follows the upcoming installation of its vector control technology in Nevada. Co-Dx's Vector Smart® PCR tests are utilized in environmental surveillance of mosquito pools for diseases like West Nile virus, Zika, dengue, and chikungunya. The technology allows mosquito abatement districts to receive same-day results, facilitating quicker and more efficient disease prevention. CEO Dwight Egan highlighted the importance of this growth in combating the spread of mosquito-borne illnesses amid increasing threats from climate change.

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Co-Diagnostics, a molecular diagnostics firm, will participate in the FIME 2024 trade show in Miami Beach, Florida from June 19-21. The company, known for its unique, patented platform for developing molecular diagnostic tests, will be hosted at the Utah booth. FIME is a premier medical trade expo attracting over 15,000 professionals and exhibitors from 116 countries. Co-Diagnostics will showcase its new Co-Dx PCR platform, which is under review by the FDA for Over-the-Counter (OTC) clearance. Attendees can visit Booth S61 to learn more about Co-Dx products, including the Co-Dx PCR Pro instrument and associated tests, which are currently under FDA review but not yet available for sale.

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Co-Diagnostics (Nasdaq: CODX), a molecular diagnostics company, has submitted its first FDA 510(k) application for the Co-Dx PCR Pro instrument and OTC Co-Dx PCR COVID-19 Test. The application was submitted via the FDA's eSTAR system and acknowledged as received. The Co-Dx PCR platform aims to decentralize gold-standard PCR diagnostics, traditionally found in high-complexity labs, to home and point-of-care settings using a smartphone interface and Co-Primers technology. The company is also preparing to seek point-of-care clearance for the COVID-19 test and has diagnostics for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex in development. CEO Dwight Egan stated this milestone would validate their platform's quality and expedite the completion of tests for other indications and regions.

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Co-Diagnostics, Inc. reported its First Quarter 2024 Financial Results, showcasing a revenue of $0.5 million, down from $0.6 million in the prior year. Operating expenses increased by 4.4% due to research and development costs. The company reported an operating loss of $10.3 million and a net loss of $9.3 million. Adjusted EBITDA loss was $8.4 million. Co-Diagnostics highlighted key business highlights, including new executive appointments and facility expansions in Salt Lake and India. The company is focused on FDA submissions for new products and continued test development for various conditions.

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Co-Diagnostics, Inc. (CODX) announced the release date for its first-quarter 2024 financial results, scheduled for May 9, 2024. The company will host a conference call and webcast to discuss the financial results with analysts and institutional investors. Management team members including CEO Dwight Egan, CFO Brian Brown, and Head of Investor Relations Andrew Benson will participate in the call.
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Co-Diagnostics, Inc. (Nasdaq: CODX) will host a booth and present at APRC 2024 in Taiwan. The conference focuses on holistic healthcare and tackling communicable diseases like tuberculosis.
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Co-Diagnostics, Inc. (CODX) inaugurates a new manufacturing facility in South Salt Lake, supported by Mayor Wood and other dignitaries. The facility will produce the Co-Dx Pro™ instrument, test cups, and patented Co-Primers™ chemistry for PCR diagnostic tests, aiming to enhance global access to high-quality diagnostics.
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Co-Diagnostics, Inc. (CODX) appoints Richard Abbott as President, David Nielsen as COO, Christopher Thurston as CTO, and Seth Egan as CCO. The new leadership team brings extensive experience in diagnostics and technology to drive the development and commercialization of the Co-Dx PCR platform and associated tests.
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Co-Diagnostics, Inc. announces the opening of a new manufacturing facility in Salt Lake City, UT, and provides updates on facilities in India. The Company CEO shared plans for in-house manufacturing of key reagent components and equipment for their new PCR platform, aiming for commercialization. The Company focuses on addressing diseases like TB, aligning with global health organizations' missions.
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Co-Diagnostics, Inc. (CODX) reported full-year 2023 financial results, with revenue at $6.8 million, a decrease from $34.2 million in the prior year due to lower demand for COVID-19 tests. Operating expenses decreased to $45.3 million, resulting in an operating loss of $42.7 million. The company reported a net loss of $35.3 million, with an adjusted EBITDA loss of $33.0 million. Despite challenges, Co-Diagnostics achieved key milestones, including clinical evaluations, FDA EUA submissions, and grant funding for test development.
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FAQ

What does Co-Diagnostics, Inc. specialize in?

Co-Diagnostics, Inc. specializes in molecular diagnostics with unique, patented technology for faster, more efficient DNA testing for various diseases.

Where is Co-Diagnostics headquartered?

Co-Diagnostics is headquartered in Sandy, Utah, USA.

What diseases can Co-Diagnostics' tests diagnose?

Co-Diagnostics offers tests for diseases such as tuberculosis, Zika, hepatitis B and C, malaria, dengue, and HIV.

What is the Co-Dx PCR platform?

The Co-Dx PCR platform includes at-home and point-of-care diagnostic solutions, designed to detect and analyze nucleic acid molecules (DNA or RNA).

What recent achievements has Co-Diagnostics made?

Co-Diagnostics recently opened new manufacturing facilities in Salt Lake City and India, enhancing production capabilities for its PCR platform and test kits.

What is the CoSara Diagnostics joint venture?

CoSara Diagnostics is a joint venture between Co-Diagnostics and Sarabhai Group in India, focused on manufacturing and selling diagnostic tests in the Indian market.

What are Co-Primers?

Co-Primers are patented oligonucleotides used in Co-Diagnostics' PCR tests to enhance accuracy and performance.

What regulatory clearances has Co-Diagnostics received in India?

The company's joint venture with CoSara has received CDSCO clearance for multiple diagnostic tests, including influenza and tuberculosis.

What is the FDA status of Co-Diagnostics' products?

Co-Diagnostics has submitted an EUA to the FDA for its Co-Dx PCR Pro™ instrument and COVID-19 test, aiming for future at-home and point-of-care use.

Who are the key executives at Co-Diagnostics?

Key executives include Dwight Egan (CEO) and Brian Brown (CFO).

Co-Diagnostics, Inc.

Nasdaq:CODX

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1.13%
Surgical and Medical Instrument Manufacturing
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United States of America
SALT LAKE CITY