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Co-diagnostics Inc.

0.3368

+0.00280.84%

Post-market: 0.3218-0.0150-4.45%18:00 EDT

Volume:311.86K

Turnover:109.85K

Market Cap:11.31M

PE:-0.27

High:0.3691

Open:0.3240

Low:0.3023

Close:0.3340

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Overview Company News Filings

All You Need to Know About CoDiagnostics (CODX) Rating Upgrade to Buy

Co-Diagnostics Full Year 2024 Earnings: Misses Expectations

Simply Wall St.

Co-Diagnostics Is Maintained at Neutral by HC Wainwright & Co.

Q4 2024 Co-Diagnostics Inc Earnings Call

Thomson Reuters StreetEvents

Co-Diagnostics Inc reports results for the quarter ended December 31 - Earnings Summary

Co-Diagnostics FY 2024 GAAP EPS $(1.24) Misses $(1.22) Estimate, Sales $3.900M Miss $4.141M Estimate

Press Release: Co-Diagnostics, Inc. Reports Full Year 2024 Financial Results

Co-Diagnostics Inc expected to post a loss of 34 cents a share - Earnings Preview

Co-Diagnostics Inc expected to post a loss of 34 cents a share - Earnings Preview

Co-Diagnostics wins dismissal of class action lawsuit

Co-Diagnostics, Inc. Wins Dismissal of Class Action Lawsuit

Co-Diagnostics, Inc. and CoSara to Host HPV and Cancer Symposium on International HPV Day 2025

Penny Stock Co-Diagnostics Withdraws FDA Application For COVID-19 Test, Plans To Submit Enhanced Version

BRIEF-Co-Diagnostics Announces Intention To Submit Enhanced Version Of Covid-19 Test To FDA

Co-Diagnostics Plans to Seek FDA Clearance for Enhanced Version of COVID-19 Test

MT Newswires Live

Co-Diagnostics Withdraws FDA Application for Covid Test

Co-Diagnostics withdraws 510k application to FDA for Co-Dx PCR COVID-19 Test

Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of Covid-19 Test to FDA for 510(K) Clearance

THOMSON REUTERS

Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance

Co-Diagnostics, Inc. to Exhibit at BioUtah's 2025 Life Sciences Day on the Hill

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This upgrade primarily reflects an upward trend in earnings estimates, which is one of the most powerful forces impacting stock prices.A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and following years.Individual investors often find it hard to make decisions based on rating upgrades by Wall Street analysts, since these are mostly driven by subjective factors that are hard to see and measure in real time. In these situations, the Zacks rating system comes in handy because of the power of a changing earnings picture in determining near-term stock price movements.As such, the Zacks rating upgrade for CoDiagnostics is essentially a positive comment on its earnings outlook that could have a favorable impa","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/know-codiagnostics-codx-rating-upgrade-160008513.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CODX"],"gpt_icon":0},{"id":"2523569255","title":"Co-Diagnostics Full Year 2024 Earnings: Misses Expectations","url":"https://stock-news.laohu8.com/highlight/detail?id=2523569255","media":"Simply Wall St.","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2523569255?lang=en_us&edition=fundamental","pubTime":"2025-03-29 21:18","pubTimestamp":1743254299,"startTime":"0","endTime":"0","summary":"AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early.NasdaqCM:CODX Earnings and Revenue History March 29th 2025. All figures shown in the chart above are for the trailing 12 month  period. Revenue missed analyst estimates by 5.5%. Earnings per share  also missed analyst estimates by 1.6%.The company's shares are down 31% from a week ago.You still need to take note of risks, for example - Co-Diagnostics has   6 warning signs    we think you should know about.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/co-diagnostics-full-2024-earnings-131819731.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CODX"],"gpt_icon":0},{"id":"2523689427","title":"Co-Diagnostics Is Maintained at Neutral by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2523689427","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2523689427?lang=en_us&edition=fundamental","pubTime":"2025-03-29 02:00","pubTimestamp":1743184800,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/CODX/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  March 28, 2025 14:00 ET (18:00 GMT)","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CODX"],"gpt_icon":0},{"id":"2522571079","title":"Q4 2024 Co-Diagnostics Inc Earnings Call","url":"https://stock-news.laohu8.com/highlight/detail?id=2522571079","media":"Thomson Reuters StreetEvents","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522571079?lang=en_us&edition=fundamental","pubTime":"2025-03-28 20:45","pubTimestamp":1743165901,"startTime":"0","endTime":"0","summary":"Dwight Egan; Chairman of the Board, Chief Executive Officer; Co-Diagnostics Inc. Brian Brown; Chief Financial Officer, Company Secretary; Co-Diagnostics Inc. Good day, and welcome to the Co-Diagnostics fourth quarter and full year 2024 earnings conference call. . Please note that this event is being recorded.I would now like to turn the conference over to Andrew Benson, Investor Relations. Please go ahead, sir.Thank you, Andrew, and good afternoon, everyone. Thank you for joining Co-Diagnostics fourth quarter and full year 2024 earnings call. 2024 was an important year for co-diagnostics. We advanced the development of the Co-Dx PCR platform and associated test pipeline and added important manufacturing infrastructure as we strengthen the foundation for the platform's commercialization. During the course of the","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/q4-2024-co-diagnostics-inc-124501161.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CODX"],"gpt_icon":0},{"id":"2522532456","title":"Co-Diagnostics Inc reports results for the quarter ended December 31 - Earnings Summary","url":"https://stock-news.laohu8.com/highlight/detail?id=2522532456","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522532456?lang=en_us&edition=fundamental","pubTime":"2025-03-28 05:02","pubTimestamp":1743109344,"startTime":"0","endTime":"0","summary":"Co-Diagnostics Inc reports results for the quarter ended December 31 - Earnings SummaryCo-Diagnostics Inc CODX.OQ reported a quarterly adjusted loss of 36 cents per share for the quarter ended Decembe","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250327:nL5N3QA26U:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CODX"],"gpt_icon":0},{"id":"2522396905","title":"Co-Diagnostics FY 2024 GAAP EPS $(1.24) Misses $(1.22) Estimate, Sales $3.900M Miss $4.141M Estimate","url":"https://stock-news.laohu8.com/highlight/detail?id=2522396905","media":"Benzinga","labels":["express"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522396905?lang=en_us&edition=fundamental","pubTime":"2025-03-28 04:04","pubTimestamp":1743105863,"startTime":"0","endTime":"0","summary":"Co-Diagnostics (NASDAQ:CODX) reported quarterly losses of $(1.24) per share which missed the analyst consensus estimate of $(1.22) by 1.64 percent.  The company reported quarterly sales of $3.900 million which missed the","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.benzinga.com/news/earnings/25/03/44523630/co-diagnostics-fy-2024-gaap-eps-1-24-misses-1-22-estimate-sales-3-900m-miss-4-141m-estimate","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"express","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CODX"],"gpt_icon":0},{"id":"2522353959","title":"Press Release: Co-Diagnostics, Inc. Reports Full Year 2024 Financial Results","url":"https://stock-news.laohu8.com/highlight/detail?id=2522353959","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522353959?lang=en_us&edition=fundamental","pubTime":"2025-03-28 04:01","pubTimestamp":1743105660,"startTime":"0","endTime":"0","summary":"SALT LAKE CITY, March 27, 2025 /PRNewswire/ -- Co-Diagnostics, Inc. , a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced financial results for the fourth quarter and full year ended December 31, 2024.-- Revenue of $3.9 million, which declined from $6.8 million during the. prior year primarily due to higher Grant revenue in 2023. Grant revenue. totaled $3.1 million while product revenue totaled $0.8 million. Pro instrument, and test cups for the new Co-Dx PCR platform. Co-Dx PCR Pro Platform, which has subsequently been withdrawn. \"We are pleased by the progress of our pipeline development in 2024,\" said Dwight Egan, Co-Diagnostics' Chief Executive Officer. \"We recently announced our decision to withdraw our 510 application for the Co-Dx PCR Pro and Co-Dx PCR COVID-19 test from the FDA, as we now prepare to gather updated clinical data in support of a new submission for an enhanced version of the test and i","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4585","BK4555","BK4568","TM","BK4022","BK4604","BK4082","CODX","BK4588","R","BK4099","BK4232","03160"],"gpt_icon":0},{"id":"2522804108","title":"Co-Diagnostics Inc  expected to post a loss of 34 cents a share - Earnings Preview","url":"https://stock-news.laohu8.com/highlight/detail?id=2522804108","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2522804108?lang=en_us&edition=fundamental","pubTime":"2025-03-26 04:24","pubTimestamp":1742934249,"startTime":"0","endTime":"0","summary":"Co-Diagnostics Inc  expected to post a loss of34cents a share - Earnings Preview Co-Diagnostics Inc CODX.OQ CODX.O is expected to show a fall in quarterly revenue when it reports  results on March 27 ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250325:nL5N3Q81Z2:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CODX"],"gpt_icon":0},{"id":"2518530244","title":"Co-Diagnostics Inc  expected to post a loss of 34 cents a share - Earnings Preview","url":"https://stock-news.laohu8.com/highlight/detail?id=2518530244","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2518530244?lang=en_us&edition=fundamental","pubTime":"2025-03-10 19:03","pubTimestamp":1741604599,"startTime":"0","endTime":"0","summary":"Co-Diagnostics Inc  expected to post a loss of34cents a share - Earnings Preview Co-Diagnostics Inc CODX.OQ CODX.O is expected to show a fall in quarterly revenue when it reports  results on March 12 ","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250310:nL8N3PT0LM:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CODX"],"gpt_icon":0},{"id":"2517571118","title":"Co-Diagnostics wins dismissal of class action lawsuit","url":"https://stock-news.laohu8.com/highlight/detail?id=2517571118","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517571118?lang=en_us&edition=fundamental","pubTime":"2025-03-07 04:36","pubTimestamp":1741293386,"startTime":"0","endTime":"0","summary":"Co-Diagnostics (CODX) announced that on March 4, the Securities & Governance Litigation Team at BakerHostetler, the legal firm retained to represen...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/co-diagnostics-wins-dismissal-of-class-action-lawsuit?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/co-diagnostics-wins-dismissal-of-class-action-lawsuit?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4568","BK4082","CODX"],"gpt_icon":0},{"id":"2517648118","title":"Co-Diagnostics, Inc. Wins Dismissal of Class Action Lawsuit","url":"https://stock-news.laohu8.com/highlight/detail?id=2517648118","media":"PR Newswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517648118?lang=en_us&edition=fundamental","pubTime":"2025-03-07 04:30","pubTimestamp":1741293000,"startTime":"0","endTime":"0","summary":"SALT LAKE CITY, March 6, 2025 /PRNewswire/ --Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that on March 4, 2025, the Securities & Governance Litigation Team at BakerHostetler, the legal firm retained to represent the Company, won complete dismissal on summary judgment of a Section 10 securities class action that had been pending against the Company in the United States District Court for the District of Utah. See Gelt Trading, Ltd. v. Co-Diagnostics, Inc. et al., Case No. 2:20-cv-00368-JNP-DBP .","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/co-diagnostics-inc-wins-dismissal-203000850.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/co-diagnostics-inc-wins-dismissal-203000850.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4568","CODX","BK4082"],"gpt_icon":0},{"id":"2516634639","title":"Co-Diagnostics, Inc. and CoSara to Host HPV and Cancer Symposium on International HPV Day 2025","url":"https://stock-news.laohu8.com/highlight/detail?id=2516634639","media":"PR Newswire","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516634639?lang=en_us&edition=fundamental","pubTime":"2025-03-03 22:30","pubTimestamp":1741012200,"startTime":"0","endTime":"0","summary":"The symposium exploring advances in cancer prevention and care is set to take place on March 4, International HPV Awareness Day, in Baroda, India. SALT LAKE CITY, March 3, 2025 /PRNewswire/ -- Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that the Company and CoSara Diagnostics Pvt. Ltd. , the joint venture between Ambalal Sarabhai Enterprises Limited  and Co-Dx, will be hosting a symposium to honor International HPV  Awareness Day 2025.CoSara CEO Mohal Sarabhai added \"In alignment with the missions of the joint venture partners, CoSara is committed to a world with increased access to high-quality infectious disease diagnostics. We believe that providing a forum for leading experts in fields like HPV and cancer to share knowledge with other researchers, physicians, oncologists and industr","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/co-diagnostics-inc-cosara-host-143000118.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/co-diagnostics-inc-cosara-host-143000118.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4588","BK4568","HST","BK4082","BK4181","BK4218","BK4585","CODX"],"gpt_icon":0},{"id":"2513002726","title":"Penny Stock Co-Diagnostics Withdraws FDA Application For COVID-19 Test, Plans To Submit Enhanced Version","url":"https://stock-news.laohu8.com/highlight/detail?id=2513002726","media":"Benzinga","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513002726?lang=en_us&edition=fundamental","pubTime":"2025-02-24 21:18","pubTimestamp":1740403120,"startTime":"0","endTime":"0","summary":"On Friday, Co-Diagnostics, Inc. withdrew its FDA 510 application for its Co-Dx PCR COVID-19 Test on the PCR Pro in favor of submitting an enhanced version of the test for 510 clearance.The company’s decision to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test related to shelf-life stability.Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit an enhanced version of the test to address the matter raised in the 510 review process.After collecting clinical evaluation data to support the new test’s performance, the company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510 OTC clearance.Price Action: CODX stock is down 14.9% at $0.60 during the premarket session on last check Monday.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/penny-stock-co-diagnostics-withdraws-131840383.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4588","BK4551","BK4585","BK4082","CODX","BNTX","BK4535","BK4568","BK4139","BK4548"],"gpt_icon":0},{"id":"2513913245","title":"BRIEF-Co-Diagnostics Announces Intention To Submit Enhanced Version Of Covid-19 Test To FDA","url":"https://stock-news.laohu8.com/highlight/detail?id=2513913245","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513913245?lang=en_us&edition=fundamental","pubTime":"2025-02-22 06:47","pubTimestamp":1740178073,"startTime":"0","endTime":"0","summary":"BRIEF-Co-Diagnostics Announces Intention To Submit Enhanced Version Of Covid-19 Test To FDA Feb 21 (Reuters) - Co-Diagnostics Inc CODX.O:CO-DIAGNOSTICS, INC. ANNOUNCES INTENTION TO SUBMIT ENHANCED VER","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250221:nTUA6CRZB4:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4082","BK4568","CODX"],"gpt_icon":0},{"id":"2513100142","title":"Co-Diagnostics Plans to Seek FDA Clearance for Enhanced Version of COVID-19 Test","url":"https://stock-news.laohu8.com/highlight/detail?id=2513100142","media":"MT Newswires Live","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513100142?lang=en_us&edition=fundamental","pubTime":"2025-02-22 05:42","pubTimestamp":1740174162,"startTime":"0","endTime":"0","summary":"Co-Diagnostics  said Friday it has withdrawn its application to the US Food and Drug Administration for its Co-Dx PCR COVID-19 test in favor of filing an enhanced test version for clearance.The decision followed talks with the FDA over \"the ability to detect a potential deterioration of one component of the test, related to shelf-life stability,\" the company said.\"Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the...review process,\" the firm said.The shares were rising past 5% in after-hours activity.","market":"sg","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["BK4082","CODX","BNTX","BK4568"],"gpt_icon":0},{"id":"2513485332","title":"Co-Diagnostics Withdraws FDA Application for Covid Test","url":"https://stock-news.laohu8.com/highlight/detail?id=2513485332","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513485332?lang=en_us&edition=fundamental","pubTime":"2025-02-22 05:32","pubTimestamp":1740173520,"startTime":"0","endTime":"0","summary":"Co-Diagnostics withdrew its application to the Food and Drug Administration for a Covid-19 test.The Salt Lake City diagnostics company said Friday it plans to submit an enhanced version of the test, known as Co-Dx PCR COVID-19 Test. Co-Diagnostics is seeking 501 review, which looks at whether a device is safe and effective.The decision to withdraw is based on discussions Co-Diagnostics had with the FDA about the ability to detect a potential deterioration of one component of the test, related to shelf-life stability, it said. Co-Diagnostics plans to address the issue before re-submitting, it said.","market":"other","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CODX","BK4568","BK4082"],"gpt_icon":0},{"id":"2513047217","title":"Co-Diagnostics withdraws 510k application to FDA for Co-Dx PCR COVID-19 Test","url":"https://stock-news.laohu8.com/highlight/detail?id=2513047217","media":"TIPRANKS","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513047217?lang=en_us&edition=fundamental","pubTime":"2025-02-22 05:05","pubTimestamp":1740171908,"startTime":"0","endTime":"0","summary":"Co-Diagnostics (CODX) announced that, following a collaborative and informative dialogue with the Food and Drug Administration, the company has wit...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/co-diagnostics-withdraws-510k-application-to-fda-for-co-dx-pcr-covid-19-test?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/co-diagnostics-withdraws-510k-application-to-fda-for-co-dx-pcr-covid-19-test?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-2","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["BK4535","BK4585","CODX","BK4588","BK4568","BNTX","BK4551","BK4139","BK4548","BK4082"],"gpt_icon":0},{"id":"2513217531","title":"Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of Covid-19 Test to FDA for 510(K) Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2513217531","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513217531?lang=en_us&edition=fundamental","pubTime":"2025-02-22 05:00","pubTimestamp":1740171630,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250221:nTUA6CRZB4:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4568","BK4082","CODX"],"gpt_icon":0},{"id":"2513108332","title":"Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) Clearance","url":"https://stock-news.laohu8.com/highlight/detail?id=2513108332","media":"PR Newswire","labels":["productRelease"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2513108332?lang=en_us&edition=fundamental","pubTime":"2025-02-22 05:00","pubTimestamp":1740171600,"startTime":"0","endTime":"0","summary":"The Company is withdrawing current submission based on FDA feedback related to shelf-life stability of a test component. SALT LAKE CITY, Feb. 21, 2025 /PRNewswire/ -- Co-Diagnostics, Inc.  , a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that, following a collaborative and informative dialogue with the Food and Drug Administration , the Company has withdrawn its 510 application to the FDA for its Co-Dx PCR COVID-19 Test on the PCR Pro*, in favor of submitting an enhanced version of the test for 510 clearance.Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument.About Co-Diagnostics, Inc.:Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnosti","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/co-diagnostics-inc-announces-intention-210000350.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/co-diagnostics-inc-announces-intention-210000350.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"productRelease","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4082","BNTX","BK4568","CODX","BK4139","BK4551","BK4585","BK4535","BK4548","BK4588"],"gpt_icon":0},{"id":"2507218476","title":"Co-Diagnostics, Inc. to Exhibit at BioUtah's 2025 Life Sciences Day on the Hill","url":"https://stock-news.laohu8.com/highlight/detail?id=2507218476","media":"PR Newswire","labels":["conferences"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2507218476?lang=en_us&edition=fundamental","pubTime":"2025-01-30 22:30","pubTimestamp":1738247400,"startTime":"0","endTime":"0","summary":"SALT LAKE CITY, Jan. 30, 2025 /PRNewswire/ -- Co-Diagnostics, Inc.  , a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced that it will be hosting a booth at BioUtah's Life Sciences Day on the Hill today at the Utah State Capitol Rotunda.The event follows the Company's participation with the Utah Governor's Office of Economic Opportunity on the World Trade Center Utah's trade mission to Asia last fall, and continues Co-Dx's outreach to strengthen global and local relationships.About Co-Diagnostics, Inc.:Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies. The Company's technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules . The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/co-diagnostics-inc-exhibit-bioutahs-143000124.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; 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