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Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System

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An automated platform designed to fight against Sepsis and Antimicrobial Resistance (AMR)

Enables rapid, automated microbial identification on the Bruker MALDI Biotyper® CA System directly from positive blood culture samples

TUCSON, Ariz., Sept. 30, 2024 /PRNewswire/ — Accelerate Diagnostics, Inc. (NASDAQ: AXDX), an innovator of rapid in vitro diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance of the Accelerate Arc system and BC kit, an innovative, automated positive blood culture sample preparation platform, for use with Bruker’s MALDI Biotyper® CA  System (MBT-CA System) and MBT-CA Sepsityper® software extension.

Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification (ID) using Bruker’s MBT-CA system. This eliminates the need for overnight culture methods, reducing the wait time for microbial ID results, which is critical in the fight against sepsis.

The Accelerate Arc system is designed to leverage the breadth of the Bruker MBT-CA reference library to provide rapid ID. This, in conjunction with our future rapid phenotypic antibiotic susceptibility testing (AST) innovation, the Accelerate WAVE™ system1, can enable same shift reporting to Antimicrobial Stewardship teams and clinicians alike. By providing clinicians with rapid ID and AST results, clinicians can get the patient on the optimal antibiotic therapy many hours sooner, which has been shown to improve patient outcomes with Sepsis, reduce antimicrobial resistance rates and hospital costs.

The Accelerate Arc system is also designed to supplant both overnight subculture as well as laborious Laboratory Developed Test (LDT) sample preparation methods. Clinical laboratories are under pressure to run FDA-cleared devices due to increased legislation and enforcement associated with the use of LDTs. Accordingly, such laboratories can now utilize the Accelerate Arc system as an automated, FDA-cleared system.

“The FDA Clearance of the Accelerate Arc system marks the beginning of an exciting journey in our broader innovation roadmap. Together with the Accelerate WAVE™ system1 we are positioned to empower laboratories to deliver faster, more actionable results to clinicians, ultimately enhancing patient care and outcomes.” said Jack Phillips, President and CEO of Accelerate Diagnostics.

About Accelerate Diagnostics, Inc. (Nasdaq: AXDX)

Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. In addition to the Accelerate Arc system, the Accelerate Pheno system and Accelerate PhenoTest® BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. The FDA-cleared Accelerate Pheno system and Accelerate PhenoTest BC kit fully automate sample preparation, identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.

© Copyright 2024 Accelerate Diagnostics, Inc. All Rights Reserved. The “ACCELERATE DIAGNOSTICS,” “ACCELERATE PHENO,” “ACCELERATE PHENOTEST,” “ACCELERATE ARC” and “ACCELERATE WAVE” diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc. All other trademarks are the property of their respective owners.

For more information about the company, its products and technology, or recent publications, visit axdx.com.

Forward-Looking Statements

Certain of the statements made in this press release are forward-looking or may have forward-looking implications within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as “may,” “will,” “expect,” “believe,” “anticipate,” “estimate,” or “continue,” or variations thereon or comparable terminology, include but are not limited to, statements about: expectations regarding the potential or benefits of Accelerate Diagnostics’ products and technologies, including the Accelerate Arc system, such as the anticipated benefits to hospitals, patients, and laboratories, as well as the expectation that the Accelerate Arc system will eliminate the need for overnight culture methods and reduce the wait time for microbial identification results; expectations regarding new or planned products and technologies, including the anticipated timing of any releases, such as with respect to the Accelerate WAVE system currently under development; and intentions and plans relating to regulatory approvals or submission, including with respect to the FDA. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to significant risks and uncertainties, including, but not limited to: volatility throughout the global economy and the related impacts to the businesses of the company’s suppliers and customers, whether due to customer demand fluctuations, supply chain constraints and inflationary pressures or otherwise; difficulties in resolving the company’s continuing financial condition and ability to obtain additional capital to meet its financial obligations; the company’s ability to obtain any regulatory approvals; and less than expected operating and financial benefits resulting from cost cutting measures. Other important factors that could cause the company’s actual results to differ materially from those in its forward-looking statements include those discussed in the company’s filings with the Securities and Exchange Commission (the “SEC”), including in the “Risk Factors” sections of the company’s most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. These forward-looking statements are also based on certain additional assumptions, including, but not limited to, that the company will retain key management personnel; the company will be successful in the commercialization of its products; the company will obtain sufficient capital to commercialize its products and continue development of complementary products; the company will be successful in obtaining marketing authorization for its products from the FDA and other regulatory agencies and governing bodies; the company will be able to protect its intellectual property; the company’s ability to respond effectively to technological change; the company’s ability to accurately anticipate market demand for its products; and that there will be no material adverse change in the company’s operations or business and general market and industry conditions. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing the company’s plans and expectations as of any subsequent date.

1 The Accelerate WAVETM system is currently in clinical trials in preparation for FDA 510(k) submission with a target time-to-result of 4.5-hours, on average.

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SOURCE Accelerate Diagnostics, Inc.

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Gentoo Media – Mandatory notification of trade

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ST JULIANS, Malta, Nov. 14, 2024 /PRNewswire/ — MJ Foundation Fundacja Rodzinna, a company related to Mateusz Juroszek, Board Member and primary insider of Gentoo Media Inc. (Gentoo) has today acquired 115,604 shares in Gentoo at a price of SEK 24,996 per share. After this transaction, close associates of Mateusz Juroszek hold 24,027,766 shares in Gentoo.

This information is subject to the disclosure requirements pursuant to Section 5-12 of the Norwegian Securities Trading Act.

For further information, contact:
Tore Formo, Group CFO, tore.formo@g2m.com, +47 91668678

About Gentoo Media

Gentoo Media is a market-leading affiliate connecting operators and players in the online gambling and sports betting industry. Gentoo Media offers an array of iGaming affiliate solutions, such as paid marketing expertise and quality traffic through our prominent industry sites including AskGamblers, Time2Play, CasinoTopsOnline, WSN and Casinomeister. In 2024, Gentoo Media (formerly GiG Media) became Gentoo Media Inc. following a legal split separating the Media and Platform and Sportsbook business in Gaming Innovation Group (GiG) into two independently listed companies. Gentoo Media Inc. is dual listed on the Oslo Stock Exchange (ticker “G2MNO”) and Nasdaq Stockholm (ticker “G2M”). www.gentoomedia.com

This information was brought to you by Cision http://news.cision.com

https://news.cision.com/gentoo-media-inc/r/gentoo-media—mandatory-notification-of-trade,c4066199

View original content:https://www.prnewswire.co.uk/news-releases/gentoo-media—mandatory-notification-of-trade-302305030.html

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Xinhua Silk Road: World IoT expo 2024 opens in E. China’s Wuxi to showcase future of smart connectivity

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BEIJING, Nov. 14, 2024 /PRNewswire/ — The World Internet of Things (IoT) Exposition 2024 kicked off on Monday in Wuxi City of east China’s Jiangsu Province, attracting industry leaders, representatives of enterprises and experts from across the globe to discuss industry trends and demonstrate innovative applications.

At the expo’s opening ceremony, Wuxi unveiled a national pilot project in intelligent connected vehicles, which aims to create a cohesive mode for car owners, vehicles and cities connection, contributing Wuxi’s expertise to smart vehicle initiatives.

Additionally, a new smart sensing chip engineering center was launched, representing an investment of over 1 billion yuan and focusing on high-density large-scale substrates and other advanced chip technologies to strengthen the city’s integrated circuit development.

The event also saw the release of several major IoT research achievements, including the 2024 IoT innovation development Taihu index and the 2024 white paper on advanced sensing technology and applications.

The three-day event features exhibitions, panel discussions, and thematic sessions that showcase the latest development in IoT innovations and applications. This year’s expo is poised to drive Wuxi’s high-quality growth in IoT while promoting global tech collaboration and knowledge sharing in the IoT field.

Wuxi has become a navigator of the IoT industry in China. The latest statistics show that in 2023, the scale of the IoT industrial cluster in Wuxi surpassed 450 billion yuan, taking the lead in Jiangsu Province.

Original link: https://en.imsilkroad.com/p/343117.html

SOURCE Xinhua Silk Road

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Agoda Highlights Five Urban Hikes for Adventurous Travelers

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SINGAPORE, Nov. 14, 2024 /PRNewswire/ — Digital travel platform Agoda introduces five urban hikes across Asia, offering travelers a chance to experience the perfect blend of city life and nature. These hikes, ranging from family-friendly to more challenging trails, provide an unmatched perspective on some of Asia’s most dynamic cities.

Whether it’s Elephant Hill in Taipei, with its stunning views of the Taipei 101, or Hong Kong’s famous Dragon Back, active travelers are in for a treat when embarking on these city hike adventures.

Andrew Smith, Senior Vice President, Supply at Agoda said: “Asia is special to have so many incredible hike routes right in the heart of these popular cities. The five highlighted hikes are just a sample of the many breathtaking city trails the continent has to offer. Adventurous travelers will want to try them all and thankfully Agoda helps make travel affordable with great value deals on over 4.5 million properties globally.”

These are the five city hikes, ranked from easiest to most challenging:

Kuala Lumpur’s Bukit Nanas Forest Reserve offers a unique experience of trekking through a tropical rainforest right in the city center. The trail is relatively easy, with well-marked paths and informative signboards about the local flora and fauna, making it a great choice for families and nature enthusiasts.

Elephant Hill in Taipei offers a short but rewarding climb. The trail is well-maintained and provides stunning views of Taipei’s skyline, including the famous Taipei 101. It’s an ideal spot for those looking to enjoy a quick escape into nature without straying far from the city.

In Singapore, the Southern Ridges trail offers a moderate hike through a series of interconnected parks and gardens. Spanning 10 kilometers, this trail provides a lush green corridor amidst the urban environment, with highlights including the Henderson Waves bridge and panoramic views of the city.

Namsan in Seoul presents a slightly more challenging hike, leading to the N Seoul Tower. The trail is popular among locals and tourists alike, offering a mix of natural beauty and cultural landmarks, with several routes to choose from depending on the desired difficulty level.

Finally, Hong Kong’s Dragon’s Back is a favorite for its breathtaking views of the coastline and the South China Sea. This moderately challenging hike is known for its undulating ridges and scenic vistas, providing a rewarding experience for those willing to tackle its ups and downs.

In each of these city hike destinations, Agoda offers great value accommodation. In addition to holiday properties, Agoda’s 130,000 flight routes and 300,000 activities ensure the platform is the one-stop travel solution to help booking an entire trip. The latest Agoda deals can be found in the Agoda app or on agoda.com/deals.

— ENDS —

 

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SOURCE Agoda

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