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

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1 year ago

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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. (Nasdaq-CM: CODX) (the “Company” or “Co-Dx”), 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that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) 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.

The decision by the Company 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 a version of the test that has been enhanced to address the matter raised in the 510(k) review process. 

The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test’s performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform.

The Company’s primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.

*The Co-Dx PCR platform (including the Co-Dx PCR Home™, Co-Dx PCR Pro™, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.

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 (DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform and to locate genetic markers for use in applications other than infectious disease.

Forward-Looking Statements:
This press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,” “expects,” “estimates,” “intends,” “may,” “plans,” “will” and similar expressions, or the negative of these words. Forward-looking statements include statements made with respect to timing for submission of the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, that streamlining the COVID-19 test will also help to create greater operational and manufacturing efficiencies, and our expectation that additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others, will follow. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission (SEC) on March 14, 2024, and in our other filings with the SEC. The Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

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SOURCE Co-Diagnostics

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Technology

AFP Launches No Code AI for Finance Certificate to Upskill Finance Teams

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52 minutes ago

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April 29, 2026

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New certificate empowers financial professionals with real-world AI skills that don’t require programming expertise

ROCKVILLE, Md., April 29, 2026 /PRNewswire/ — The Association for Financial Professionals (AFP) announced the launch of its No Code AI for Finance Certificate Program. Taught by an AI expert with a background in finance and operations, the virtual on-demand program goes beyond theory, providing practical applications of AI in finance.

Key takeaways

Practical curriculum: The certificate course, developed through feedback from finance practitioners, provides hands-on exercises and lessons on building a data foundation, training and interpreting machine learning models, generating insights with generative AI and embedding ethics in AI adoptionSelf-paced learning: Once registered for the certificate, eight hours of on-demand content across four modules are available in AFP Learn.Professional recognition: The certificate course is eligible for 9.6 CTP, FPAC and CCM Credits and provides a Digital Badge and printable certificate upon successful completion.

Why it matters
The finance function is at a critical turning point. Data volumes are growing while finance professionals are increasingly being asked to do more with less. The No Code AI for Finance Certificate equips teams to scale their impact by automating labor-intensive workflows and speeding up processes while maintaining accuracy.

Comprehensive curriculum
The certificate program includes four modules that are tailored to the specific needs of finance professionals:

Data Foundations for Trustworthy Finance Analytics: Learn about decision cycles AI can shorten, mitigation tactics for AI hallucinations, and the difference between supervised, unsupervised and generative tasks.Understanding the Full Machine Learning Process and Its Results: Learn to frame finance machine learning problems correctly, choose and defend the right success metrics for each task and translate model results into business-ready insights.Generative AI for Finance: Smarter Questions, Faster Insights: Learn to write prompts for GenAI, generate and refine GenAI-supported data-prep code, pressure test insights with GenAI and apply guardrails for GenAI.From AI Capability to Adoption & Ethics by Design: Learn to select and prioritize a first AI pilot, design an operating cadence, draft an ethics and risk control sheet, and define ROI and adoption KPIs.

Each module includes downloadable assets to help learners apply the lessons to their day-to-day work.

Key quote
“At AFP, we recognized a clear need for training that addresses finance-specific applications of AI. This certificate acts as a bridge to connect financial professionals to the transformative power of AI, ensuring they remain the indispensable strategic partners their organizations require,” said Pat Culkin, President & CEO of AFP.

Ready to lead AI adoption in your finance team?
Enroll in the certificate program and begin working toward the No Code AI for Finance Certificate.

FAQs
Who should enroll in this certificate program?
The program is designed for financial professionals at all levels looking to integrate AI into their workflows.

Are there any prerequisites for the course?
There are no prerequisites for this course. It is accessible to professionals of all technical backgrounds. No coding knowledge is required.

How is the course delivered?
The course consists of eight hours of on-demand content across four modules, which can be completed at the learner’s own pace.

How much does it cost to enroll in the certificate program?
The certificate program is $295 for AFP members and $495 for non-members.

About AFP®
Headquartered outside of Washington, D.C., and located regionally in Singapore, the Association for Financial Professionals (AFP) is the professional society committed to advancing the success of treasury and finance members and their organizations. Established and administered by AFP, the Certified Treasury Professional and Certified Corporate FP&A Professional credentials set standards of excellence in treasury and finance. Each year, AFP hosts the largest networking conference worldwide for about 7,000 corporate financial professionals.

Media contact
Joe Hodanich
Senior Director, Digital Strategy & Content
Association for Financial Professionals
Email: jhodanich@financialprofessionals.org

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SOURCE Association for Financial Professionals

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KT Corp. Files 2025 Annual Report on Form 20-F

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52 minutes ago

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April 29, 2026

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SEOUL, South Korea, April 29, 2026 /PRNewswire/ — KT Corporation (NYSE: KT), South Korea’s largest integrated telecom and digital platform service provider, announced that it has filed its Form 20- F Annual Report on April 29th, 2026 for the year ended December 31, 2025 with the Securities and Exchange Commission of the United States. The report can be accessed on KT’s English website at https://corp.kt.com/eng in the Investors section under Business Report as well as the SEC’s Edgar database at www.sec.gov. Shareholders may also request a hard copy of the Form 20-F Annual Report that includes audited financial statements of 2025, free of charge, by sending an e-mail to the Company’s IR department at ktir@kt.com.

About KT Corporation (KRX: 030200; NYSE: KT)

KT Corporation is the leading integrated telecommunications and platform service provider based in South Korea. Principal services include mobile, Broadband, IPTV, B2B communications, and fixed-line telephony. The Company has industry-leading market presence in Broadband, media services, and fixed-line telephony by maintaining the No.1 market share positions. Also, the Company is the No.1 player in B2B communications and offers a wide range of digital transformation services (DC, Cloud, AI, etc.). Additionally, the Company possesses a well-balanced portfolio of diverse subsidiaries focusing on media/content, financial services, real estate developments, and commerce industries.

Forward-Looking Statements

This communication contains “forward-looking statements” that are based on our current expectations, assumptions, estimates and projections about us and the industries in which we operate. The forward-looking statements are subject to various risks and uncertainties. Generally, these forward-looking statements can be identified by the use of forward-looking terminology such as “anticipate,” “believe,” “estimate,” “expect,” “intend,” “project,” “should,” and similar expressions. Those statements include, among other things, the discussions of our business strategy and expectations concerning our market position, future operations, margins, profitability, liquidity and capital resources. We caution you that reliance on any forward-looking statement involves risks and uncertainties, and that although we believe that the assumptions on which our forward-looking statements are based are reasonable, any of those assumptions could prove to be inaccurate, and, as a result, the forward-looking statements based on those assumptions could be incorrect. The uncertainties in this regard include, but are not limited to, those identified in the risk factors discussed above. In light of these and other uncertainties, you should not conclude that we will necessarily achieve any plans and objectives or projected financial results referred to in any of the forward-looking statements. We do not undertake to release the results of any revisions of these forward-looking statements to reflect future events or circumstances.

IR department:
+82-70-4193-4036
ktir@kt.com

View original content:https://www.prnewswire.com/news-releases/kt-corp-files-2025-annual-report-on-form-20-f-302757200.html

SOURCE KT Corp.

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SK TELECOM CO. LTD. FILES ITS ANNUAL REPORT ON FORM 20-F

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52 minutes ago

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April 29, 2026

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SEOUL, South Korea, April 29, 2026 /PRNewswire/ — On April 29, 2026, SK Telecom Co., Ltd. filed its Annual Report on Form 20-F for the year ended December 31, 2025 with the U.S. Securities and Exchange Commission. The 2025 Annual Report on Form 20-F can be viewed on www.sktelecom.com, as well as from the website of the U.S. Securities and Exchange Commission at www.sec.gov. Printed copies of SK Telecom’s complete audited financial statements (including footnotes) as of and for the year ended December 31, 2025 can be requested, free of charge, by written request to skt.ir@sk.com.

View original content:https://www.prnewswire.com/news-releases/sk-telecom-co-ltd-files-its-annual-report-on-form-20-f-302757201.html

SOURCE SK Telecom Co., Ltd

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