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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that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k)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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Sesame Software Named Fastest to Implement and Best Estimated ROI in G2’s Fall 2026 Reports, Previews Sesame Software 7.0

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48 minutes ago

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October 27, 2026

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Mid-market recognition from verified users caps a strong 2026 as the company announces the beta of its biggest platform release in years

SANTA CLARA, Calif., Oct. 27, 2026 /PRNewswire/ — Sesame Software, the Enterprise Data Management leader, today announced it has earned two mid-market badges in G2’s Fall 2026 reports, Fastest Implementation and Best Estimated ROI, based on verified user reviews. Heading into 2027, the company also previewed Sesame Software 7.0, its biggest platform release in years, with a beta opening this winter.

Recognized by G2 Users

The badges reflect what users say about Sesame Software: it’s up and running in minutes, needs no coding or data mapping, and pays for itself quickly. Teams use it to replicate data in near real time, build pipelines into warehouses like Snowflake, back up and archive records, and run verified migrations between systems.

“Customers don’t want a data project. They want their data where they need it, working as soon as possible,” said Joshua Demumbreum, Director of Product Operations, Sesame Software. “Hearing that back from users, in their own words, is a great way to close the year.”

Coming Soon: Sesame Software 7.0

What’s new in 7.0:

New interface: fewer clicks, easier navigation, clearer logs, and reporting on which records each job movesRebuilt engine: faster jobs, bigger data volumes and fewer failures, with data cleanup built into every jobRewritten connectors: simpler templates that behave the same across every connectorSimpler upkeep: Java 25 support, embedded Tomcat, and one-step upgrades

“After 30-plus years in enterprise data, 7.0 is our biggest step forward yet,” said Nathan Lugert, Senior Software Engineer, Sesame Software. “We can’t wait to get it into users’ hands.”

About Sesame Software

Sesame Software is the Enterprise Data Management leader, delivering data rapidly for enhanced reporting and analytics. Sesame Software’s data platform offers superior solutions for data warehousing, integration, as well as backup, and compliance to fit your business needs. Quickly connect to SaaS, on-premise, and cloud applications for accelerated insights. With over 30 years of expertise, Sesame Software helps businesses take back control of their data, access it from anywhere, ensure security and compliance, and unlock its power to grow.

Media Contact:
Kristen Besselsen, Director of Marketing
kristen.besselsen@sesamesoftware.com
www.sesamesoftware.com

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SOURCE Sesame Software

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RS earned three awards at the 2026 Moxa Global Distributor Summit

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48 minutes ago

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October 27, 2026

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The three awards recognize RS for demonstrable leadership in small to medium-sized business sales, energy sector sales, and regional sales.

FORT WORTH, Texas, Oct. 27, 2026 /PRNewswire/ — RS, a high-service global product and service solutions provider for industrial customers, earned three top awards at the 2026 Moxa Global Distributor Summit. Held in Nashville, Tennessee, September 8–11, this exclusive summit welcomed Moxa team members and partners from all over the world to “Collaborate to Lead” and discuss business and strategy updates, emerging industrial infrastructure trends, secure OT connectivity, and next-generation technologies like AI data centers and energy storage.

RS combines immediate access to Moxa products with deep technical expertise to solve complex operational challenges.

During the event, Moxa — a global leader in industrial networking, computing, and edge connectivity solutions — presented RS Americas with its:

2026 Top Global Sales Award for small to medium-sized businesses2026 Top Global Sales Award for energy businesses2026 Platinum Award for top sales in the Americas region

These awards recognize RS for outstanding sales achievements and exceptional partnership in three key market segments. Together, RS and Moxa deliver secure network deployments and reliable edge connectivity for industrial automation customers across the manufacturing, energy, and commercial sectors.

“Partnering with Moxa enables us to provide industrial customers with the high-performance networking technologies they need to advance their digital transformation and build resilient operations,” said Marie Dawson, Sr. Director of Strategic Supplier Engagement at RS. “Earning three top honors at the 2026 Moxa Global Distributor Summit validates our approach — combining immediate access to quality Moxa products with deep technical expertise to solve complex operational challenges and keep critical infrastructure running across industries.”

“RS continues to demonstrate outstanding leadership in advancing edge connectivity and network reliability across key industrial sectors,” said Mat Stewart, Vice President of Sales at Moxa. “We are proud to recognize the RS Americas team for their exceptional global and regional performance over the past year and look forward to building on this momentum together.”

To learn more about the RS portfolio of Moxa products and solutions, visit the embedded links.

PR Image Download:
RS Moxa Awards PR.jpg

PR Image Caption:
The RS Americas team accepted three top sales performance awards at the 2026 Moxa Global Distributor Summit. Pictured from left to right: Moxa Americas Vice President of Sales Mat Stewart, RS Americas Product Director Chris Cole, RS Americas Eastern Regional Sales Manager John Allen, RS Americas Senior Director of Strategic Supplier Engagement Marie Dawson, RS Americas Supplier Manager Evie Hooper, RS Americas Category Manager Megan Shaw, Moxa Americas Director of Channel Sales Pat Sweeney, RS Americas Product Portfolio Manager Gary Guess, and Moxa Americas President Chad Chesney.

About RS
RS is a high-service global product and service solutions provider for industrial customers, enabling them to operate efficiently and sustainably. We operate in 33 markets, stock over 875,000 industrial and specialist products, and list an additional five million relevant for our industrial customers, sourced from over 2,500 suppliers. This extensive range supports our customers across the industrial lifecycle of designing, building, and maintaining equipment and operations. We enhance their experience through a tailored service model, leveraging our efficient physical, digital, and process infrastructure sustainably. We combine a technically led and digitally enabled approach with an exceptional team of experts; ultimately, it’s our people that make the difference. Our purpose, making amazing happen for a better world, reflects our focus on delivering results for people, planet, and profit.

RS Group plc is listed on the London Stock Exchange with stock ticker RS1, and in the year ended March 31, 2026, reported revenue of $3,871.07 million. For more information, please visit https://www.rsgroup.com/ or connect with us on LinkedIn or X (Twitter).

About RS in the Americas
In the Americas region, RS stocks more than 250,000 industrial and electronic products from more than 700 trusted suppliers. These solutions cover categories extending from automation and control equipment to interconnect, passive, active, and electromechanical components and include more than 90,000 high-quality, competitively priced RS PRO products. For more information, please visit https://us.rs-online.com or connect with us via social media on LinkedIn, Facebook, and YouTube.

Editorial Contact & Media Inquiries:
Laurie Tortorello, Director of People & Culture Communications, RS Americas
Laurie.Tortorello@rsgroup.com

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SOURCE RS

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Union Home Mortgage Selected for USDA Rural Development Delegated Authority Pilot Program

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48 minutes ago

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October 27, 2026

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One of six lenders chosen nationwide to deliver an enhanced USDA loan experience for eligible rural borrowers

STRONGSVILLE, Ohio, Oct. 27, 2026 /PRNewswire/ — Union Home Mortgage (UHM), a high-growth independent mortgage banking company with a world-class culture, announced today that it has been selected by the U.S. Department of Agriculture Rural Development to participate in the expanded Delegated Authority Lender Interactive Test Environment (LITE) Pilot Program for the Single Family Housing Guaranteed Loan Program, further strengthening the company’s ability to serve homebuyers in rural communities across the country. UHM is one of six lenders nationwide chosen to join the initiative, which begins on December 1, 2026.

The pilot program grants participating lenders greater authority in the loan approval and closing process, allowing qualified borrowers to move through the mortgage journey more efficiently while maintaining rigorous underwriting and compliance standards. By reducing pre-closing approval requirements from USDA, the program is designed to accelerate loan processing timelines and expand homeownership opportunities for eligible families in rural communities across the country.

“We are honored to partner with USDA Rural Development to help rural borrowers access more opportunities to achieve the dream of homeownership, which is one of the most powerful ways to build financial stability and strengthen communities,” said Bill Cosgrove, CEO of Union Home Mortgage. “Being selected for this pilot program reflects our commitment to providing world-class service and innovative solutions to our borrowers, and we thank USDA for entrusting us with this increased responsibility.”

Through the USDA Single Family Housing Guaranteed Loan Program, eligible low- and moderate-income borrowers can access affordable financing options, including 100% financing for homes in qualifying rural areas. According to USDA Rural Development, homebuyers can buy existing, build new, or cover the cost of rehabilitating, improving, or relocating a home with a Single Family Housing loan guarantee. As a participant in the Delegated Authority LITE Pilot Program, UHM will be positioned to deliver these benefits with greater speed and efficiency while continuing to provide personalized guidance throughout the homebuying journey.

The selection further underscores UHM’s reputation as a trusted lending partner and aligns with the lender’s focus on responsible growth, operational excellence, and expanding access to affordable mortgage solutions in communities of all sizes.

For more information about Union Home Mortgage, visit www.uhm.com. For information about USDA Rural Development housing programs, visit www.rd.usda.gov.

About Union Home Mortgage
Union Home Mortgage Corp. (UHM) is a high-growth, full-service retail, wholesale, and consumer direct independent mortgage banking company with branches across the U.S. in 49 states + D.C. UHM is an in-house loan servicer offering world-class customer service through high touch communication & technology. A privately held family business, with a collaborative culture that stands out in the mortgage industry, UHM Partners (employees) are guided by a Code of Conduct that emphasizes respect, open communication, and accountability. All these principles translate to industry-leading customer retention and satisfaction. Some honors include being a Six-Year USA TODAY Top Workplace and a Twelve-Year Northeast Ohio Top Workplace. Learn more at www.uhm.com.

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SOURCE Union Home Mortgage

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