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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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2 years 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that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k)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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America’s Largest Political Group Is Getting Its Own Election Night

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26 minutes ago

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October 26, 2026

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A record 45% of Americans identify with neither party. On November 3, they get the first nationally televised Election Night built around the independent voter bloc, presented by United Independents, the organization behind the Independent National Convention, in partnership with DeFiance Media.

WASHINGTON, Oct. 26, 2026 /PRNewswire/ — Can the country’s largest bloc of voters turn identity into representation? Independents now make up 45% of U.S. adults, a record high in Gallup’s 2025 data, yet partisan coverage continues to dominate mainstream mediums. On November 3, one broadcast will cover the election from the Independent point of view.

Broadcast live from the National Press Club’s television studio in Washington, D.C. Election Night 2026: Independent Edition is an eight-hour program hosted by Christopher Life, founder and CEO of United Independents, and Macy Gunnell, NewsForce’s White House correspondent. DeFiance Media will be producing and streaming the broadcast.

Built on live election data from The Associated Press (AP), the program will call the national races as the returns come in. Then it goes where other broadcasts don’t: race-by-race coverage of independent candidates in consequential congressional contests, and guest conversations with the strategists and organizers behind them.

Built for the Voters Both Parties Are Chasing

Two generations of Americans have come of age as independent voters, and in 74 years of nationally televised Election Night broadcasts, not one has been built around them. This one is: national results and the balance of power, dedicated coverage of the independent candidates who could tip the next Congress, and a live chat with selected viewer questions put to the hosts and guests on air.

Open to Every Newsroom

Television pool feed. U.S. television outlets, including local stations, can carry the program live, in full or in part, separate from DeFiance Media’s full-program streaming.Social streaming. The broadcast streams through participating social media partners. Channels that want to carry it can sign up at Election2026.live.Live clips and excerpts. Newsrooms, commentators, and creators can pull portions of the program for reporting and social distribution while the broadcast is underway.

Request access through the Media & Distribution Access Form at Election2026.live.

Free and Accessible Nationwide

Going live Tuesday, November 3rd, 2026, from 6 PM- 2 AM ET. Updates, guest announcements, and viewing instructions: Election2026.live.

Media Contact

Shaun Saunders
shaun@graffiticreativegroup.com

View original content:https://www.prnewswire.com/news-releases/americas-largest-political-group-is-getting-its-own-election-night-302919753.html

SOURCE DeFiance Media

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Pianist Michael Weinstein Wins Best Social Media Music Collaborations at the 2026 Vega Awards

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26 minutes ago

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October 26, 2026

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With more than a million followers across social media, Weinstein’s piano collaborations bring together vocalists from around the world to create unique musical performances and reach new audiences.

SOUTH SALEM, N.Y., Oct. 26, 2026 /PRNewswire-PRWeb/ — Pianist, entrepreneur and social media creator Michael Weinstein has been recognized at the 2026 Vega Digital Awards in the Social Media Collaboration category for his music collaboration series, Piano Sessions: Bringing Voices Together Through Music.

“I love collaborating with talented singers including building friendships that have become just as meaningful as the music itself.”

Weinstein has built a social media audience of more than a million followers across TikTok, Instagram and other platforms by sharing piano performances and collaborations with singers from around the world. His videos feature vocalists performing alongside his piano accompaniment, creating intimate musical performances that showcase each artist’s individual talent and style.

While Weinstein has spent much of his professional career building businesses and marketing consumer brands, music has always remained one of his greatest passions.

“Music has always been a huge part of my life and one of the things I enjoy most is collaborating with other musicians,” said Weinstein. “I’ve had the opportunity to work with so many incredibly talented singers and I love being able to play alongside them and create something special together. It’s also rewarding to introduce these artists to new audiences while building relationships and friendships that have become just as meaningful as the music itself.”

An accomplished pianist and keyboardist, Weinstein has collaborated with an impressive range of vocalists, including artists who have performed and recorded with Maroon 5, Sting, John Legend, Alicia Keys, Usher, Lauryn Hill and Jill Scott. He has also collaborated with standout performers from American Idol, America’s Got Talent and The Voice.

Weinstein is also planning a live concert in New York City in 2027, bringing together several of the talented vocalists featured on his social media channels for a special collaborative performance. Additional details will be announced in the coming months.

Outside of music, Weinstein is the Founder and CEO of JAM Direct, a marketing and advertising agency, and former Chief Marketing Officer of Allstar Products Group, where he was responsible for marketing some of the most successful products in “As Seen On TV” history, including the Snuggie, ShamWow and Shake Weight.

Watch Michael Weinstein’s performances here:

https://linktr.ee/mweinsteinmusic

About the Vega Digital Awards

The Vega Digital Awards is an international competition recognizing excellence in social media, digital marketing and brand strategy. Judged by the International Awards Associate (IAA), the competition honors work that demonstrates innovation, effectiveness and measurable impact across the global marketing landscape.

Media Contact

Michael Weinstein, JAM Direct, 1 9146610053, mw@jamdirect.com, https://michaelweinstein.me/

View original content to download multimedia:https://www.prweb.com/releases/pianist-michael-weinstein-wins-best-social-media-music-collaborations-at-the-2026-vega-awards-302919551.html

SOURCE JAM Direct

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Technology

Landis+Gyr Secures Major Contract with Leading US Utility

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1 hour ago

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October 26, 2026

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CHAM, Switzerland and ALPHARETTA, Ga., Oct. 26, 2026 /PRNewswire/ — Landis+Gyr Group AG (SIX: LAND), a global energy technology leader driving intelligent innovation across the grid, today announced that it has secured a major contract with a leading US investor-owned electric utility. The agreement covers more than 3 million advanced metering endpoints.

Under the agreement, Landis+Gyr will provide Revelo meters and associated network and head-end system technologies, complemented by advanced security solutions, premium support, and software maintenance and services. The deployment is expected to advance the utility’s grid modernization objectives by enhancing security, grid visibility and operational performance.

“This important win reflects the strong momentum of our Grid Edge Intelligence portfolio and the trust customers place in Landis+Gyr to support large-scale grid modernization programs. By combining advanced metering, integrated technology, security and support capabilities, we look forward to helping this utility enhance grid visibility, reliability and operational performance,” said Peter Mainz, Chief Executive Officer of Landis+Gyr.

About Landis+Gyr

Landis+Gyr is a global energy technology leader, delivering intelligent solutions that connect devices, data, and decisions across the grid. Trusted by more than 2,000 utilities worldwide, we transform traditional devices into intelligent, networked sensors, giving utilities real-time grid visibility and system control. With these combined insights, electric, gas, and water companies can anticipate demand, optimize operations, and deliver energy that’s more reliable, resilient, accessible, safe, and sustainable for everyone. For more information, please visit our website www.landisgyr.com.

View original content to download multimedia:https://www.prnewswire.co.uk/news-releases/landisgyr-secures-major-contract-with-leading-us-utility-302919687.html

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