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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that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k)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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Vantrue Announces Early Black Friday Sale with Up to 44% Off Select Dash Cams

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2 hours ago

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October 25, 2026

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November 1–21, 2026 | Official Website: Vantrue.com

SHENZHEN, China, Oct. 25, 2026 /PRNewswire/ — Vantrue, a dash cam brand dedicated to helping drivers capture the road with confidence, is launching its three-week Black Friday campaign from November 1 to November 21, 2026. The event brings together discounts of up to 44% on selected dash cams, a 100% win-rate prize wheel for subscribers, and exclusive bidding events, giving drivers multiple ways to discover and save on Vantrue products.

Every Eligible Spin Wins a Prize

The Black Friday excitement starts with Vantrue’s 100% win-rate spin wheel. Visitors can subscribe through the official website and spin for a chance to receive exciting rewards, including the latest Vantrue dash cams, special prize bundles, and other surprises. Each subscriber is eligible for one spin during the campaign.

Black Friday Deals in Two Waves

Vantrue’s Black Friday offers will roll out in two waves, featuring discounts on selected dash cams for everyday drivers, rideshare professionals, and those looking to upgrade their in-car recording setup.

Wave 1: November 1–10, 2026

Vantrue E1 Lite: 36% off — $69.99 (regular price: $109.99)
 Vantrue N2X: 36% off — $159.99 (regular price: $249.99)
 Vantrue N4S: 44% off — $199.99 (regular price: $359.99)
 

Wave 2: November 11–21, 2026

Vantrue E1 Pro S: 35% off — $129.99 (regular price: $199.99)
 Vantrue N5S: 36% off — $293.99 (regular price: $459.99)
 Vantrue N4 Pro S: 40% off — $279.99 (regular price: $469.99)
 

Exclusive Bidding Events Add More Excitement

In addition to the promotional pricing, Vantrue will host two special bidding events, offering participants another way to pursue selected dash cams at competitive prices.

BID #1: November 5–7, 2026 — Bid on featured products for a chance to secure them at a lower price.BID #2: November 12–14, 2026 — Return for another opportunity to bid on premium models.

With multiple ways to participate throughout the three-week event, Vantrue’s Black Friday campaign combines savings, interactive rewards, and special shopping opportunities in one destination.

Join Vantrue’s Black Friday Event

From November 1 through November 21, 2026, drivers can explore the latest offers, take part in the prize wheel, and join the bidding events through Vantrue’s official website.

Visit https://www.vantrue.com/ for campaign details and product offers.

About Vantrue

Founded in 2015, Vantrue is a leading global dash cam brand dedicated to providing intelligent, reliable, and user-centric driving solutions. With a focus on innovative technology, dependable performance, and user-friendly design, Vantrue develops dash cams for everyday drivers, families, and professionals on the road. Committed to helping drivers capture every journey with greater confidence and peace of mind, Vantrue continues to innovate to make every drive safer and every moment worth capturing.

Media Contact
Vantrue Media Relations
Email: support@vantrue.net
Website: https://www.vantrue.com

View original content:https://www.prnewswire.com/news-releases/vantrue-announces-early-black-friday-sale-with-up-to-44-off-select-dash-cams-302918196.html

SOURCE Vantrue

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LexisNexis Coplogic Solutions Introduces Field Clarity for LexisNexis® Desk Officer Reporting System (DORS) at IACP 2026

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5 hours ago

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October 25, 2026

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A new, modern DORS and Field Clarity, the First AI-Guided Smartphone Video Assistant, Enhances Community Experience and Helps Improve Evidence, Case Building

ORLANDO, Fla., Oct. 25, 2026 /PRNewswire/ — LexisNexis® Coplogic™ Solutions today announced its modernized LexisNexis® Desk Officer Reporting System (DORS) community online reporting solution and the addition of DORS with Field Clarity, an AI-guided video assistant designed to improve field documentation accuracy and enable faster resolution by law enforcement agencies (LEAs). Field Clarity is designed to help community members submit reports to their local LEAs using DORS via intuitive step-by-step instructions. A hands-on experience for DORS with Field Clarity will be available for demonstration during the 2026 International Association of Chiefs of Police (IACP) annual conference.

“Agencies generally look to strategic partners like us not just for technology, but also for relief, reinforcement, and credibility across three tightly connected challenges: public expectation, workforce strain and digital evidence overload,” said Jason LaRue, associate vice president, LexisNexis Coplogic Solutions. “Our modernized LexisNexis Desk Officer Reporting System (DORS) helps agencies improve officer safety along with community member experiences. Field Clarity strengthens video evidence quality and digital evidence management to reduce friction and alleviate strain on a challenged workforce.”

Key Highlights
Integrated into LexisNexis® Desk Officer Reporting System (DORS), Field Clarity is the first AI-Guided video assistant for community member online reporting that:

Transforms data capture from passive intake into intelligent, guided capture to help create more positive officer and civilian mobile-first experiencesDrives more accurate field documentation, evidence and case building to help with faster resolution and enhanced public safetyBenefits civilians submitting reports with intuitive, step-by-step instructions, almost like having a digital assistant with them in real timeBenefits officers by bringing video, photos and scanned data together for a clearer picture of an event without the need to track down additional details

How the DORS with Field Clarity Solution Works
DORS allows each law enforcement agency to collect information directly from civilians on more than 200 incident types based on the needs of their community. DORS and Field Clarity make the filing of an online report experience easier by guiding users intuitively through each step of the process on their smartphone device, similar to having a personal digital assistant. Instead of asking a driver, for example, to fill out forms and guess what’s needed, the Field Clarity conversational interface prompts them to scan their driver’s license, capture a VIN or record a short walkaround video explaining what happened during the incident, all while capturing the data necessary to complete the report.

For civilians, being able to easily film on-scene evidence means less confusion and need for reentries or follow-up by the sworn officer responsible for approving reports. For officers, the benefits include cleaner, more complete accident reports and less time spent requesting and gathering additional details. With reports fed directly into the agency’s Record Management System (RMS), law enforcement also benefits from more efficient workflows and stronger documented cases for their investigators. DORS is used by nearly 600 agencies in North America, saving agencies approximately 900,000 personnel hours and $90 million annually*

“Trust in law enforcement is built one interaction at a time. Every opportunity for a community member to engage with their police department matters, including something as routine as filing a report,” said Sarah E. Connolly, co-founder of Guardian Communications, FBI-LEEDA instructor and retired Baltimore Police lieutenant and PIO. “When technology makes that process easier, improves the quality of information collected and supports a more responsive agency, it has the potential to do more than improve efficiency. It can help strengthen the relationship between law enforcement and the communities they serve.”

LexisNexis Coplogic Solutions delivers solutions and capabilities that can create a clearer line of sight from the field to law enforcement leadership, strengthening the connection between daily operations, workforce support, data management and community trust. DORS with Field Clarity is available through LexisNexis® Command Center, a single access point to the LexisNexis Coplogic Solutions data and analytics solutions suite, including LexisNexis®  BuyCrash®, LexisNexis® eCrash and LexisNexis® eCitation solutions. Coplogic Solutions also offers Unified Performance Dashboards for crash and citation mapping and illustrated visualizations, which connect field data with contextual insight in a single, coherent view – so law enforcement leaders can better understand and more confidently explain to their communities not just what is happening in near-real time, but also why. 

To speak with Coplogic law enforcement experts about LexisNexis Desk Officer Reporting System (DORS) with Field Clarity and experience the solution firsthand, visit LexisNexis Coplogic Solutions at IACP Booth #941, October 24 – 27, 2026 in Orlando, Florida. To learn more, check out this video: LexisNexis® Desk Officer Reporting System (DORS).

About LexisNexis Risk Solutions
LexisNexis® Risk Solutions provides customers with information-based analytics and decision tools that combine public and industry-specific content with advanced technology and algorithms to assist them in evaluating and predicting risk and enhancing operational efficiency. Headquartered in metro Atlanta, Georgia, the company has offices throughout the world, serves customers in more than 190 countries and territories and is part of RELX. For more information, please visit LexisNexis Risk Solutions.

About LexisNexis Coplogic Solutions
LexisNexis® Coplogic™ Solutions is committed to meeting law enforcement agencies where they are on the road to saving more lives and helping take them where they want to be by delivering an innovative full suite of data sophistication solutions to create workflow efficiencies while delivering world-class crash and citation data and analytics visualizations through advanced technology. Our proven solutions, developed by and specifically for law enforcement, can help agencies operate more effectively, increase services to their communities and improve traffic and overall public safety through electronic, mobile-first authoring capabilities, web-based eCommerce solutions, analytics and more. For more information, please visit risk.lexisnexis.com/Coplogic.

Media Contacts: 
Chaz Abbott
LexisNexis Risk Solutions
chaz.abbott@lexisnexisrisk.com
+1 949.922.1167

*Based on a 2025 LexisNexis Coplogic Solutions internal study

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SOURCE LexisNexis Risk Solutions

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World Young Scientist Summit 2026 Opens in Wenzhou, Zhejiang

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5 hours ago

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October 25, 2026

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WENZHOU, China, Oct. 25, 2026 /PRNewswire/ — A news report from China Daily:

On October 24, the World Young Scientist Summit 2026 opened in Wenzhou, Zhejiang. The event is hosted by the China Association for Science and Technology (CAST), the Zhejiang Provincial People’s Government, and the World Association of Young Scientists. Nearly 800 representatives, including scientists, educators, and entrepreneurs from more than 60 countries and regions, are attending the summit.

With the theme “Gathering Talents Worldwide to Create a Better Future,” the summit’s annual agenda is “Global Youth Action in the AI Era: Building a Sustainable Future.” It aims to draw on the insights of young people around the world, deepen international sci-tech cooperation, and jointly address questions about young people, science, the world and the future.

Delivered keynote speeches respectively on education reform in the AI era, AI and processor chips, young women scientists’ participation in science, and quantum computing. They explored new opportunities for scientific research, talent cultivation, and international cooperation in the AI era.

This year’s summit placed greater emphasis on the growth needs of young scientists, with young talents under the age of 45 accounting for 88 percent of participants. It aimed to build a cluster of international journals, bring together young scientific talent, facilitate a batch of international collaborative projects and advance the application and commercialization of scientific and technological achievements. The summit released the Report on the Distribution and Mobility of Young Scientists in the Field of Embodied Intelligence, launched the World Young Scientist Summit Partner Journal Program and the 2026 World Young Scientist Innovation and Entrepreneurship Growth Support Program. It also published the “Young Scientist Pioneers 2035” list and announced the 2026 Sustainable Development Young Scientist Award. The awards were presented to four Chinese and foreign scientists.

In addition, the conference focused on fields such as future manufacturing, quantum information, embodied intelligence, brain-computer intelligence, environmental science, deep-sea resources, and life and health, and held 12 parallel forums. It also included the “Gravitation π” Future Technology and Concept Products Exhibition and Exchange, local thematic side events, and sci-tech and humanities study visits, further building an interdisciplinary, cross-regional and cross-sector platform for youth sci-tech exchange and cooperation.

View original content to download multimedia:https://www.prnewswire.com/apac/news-releases/world-young-scientist-summit-2026-opens-in-wenzhou-zhejiang-302918767.html

SOURCE China Daily

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