Technology

Accelerate Diagnostics Announces FDA Clearance of its Accelerate Arc™ System

Published

6 hours ago

September 30, 2024

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.

Technology

StarfishETL Introduces AI-Powered Enhancements to Simplify Field Mapping, Script Writing, and SQL Queries

Published

58 seconds ago

September 30, 2024

Low-code iPaaS announces new suite of AI-enabled features

CHICAGO, Sept. 30, 2024 /PRNewswire/ — StarfishETL, a low-code iPaaS built for scalable data connections, is delighted to announce a new suite of AI-enabled features to its platform.

The application’s user-friendly Cloud Cartographer now includes three AI-assisted features to support more intelligent field mapping, script writing, and SQL query writing.

AI-Assisted Field Mapping

AI-assisted field mappings take auto-mapping to the next level. Users can apply this feature to get a quick jump-start of field-level mapping exercises. It can evaluate the list of available Origin fields and the Destination fields for that stage and come up with a recommendation for which fields should be matched.

If the user is only interested in mapping a few fields, they can easily narrow down the list prior to processing. All mapping suggestions can be reviewed and approved individually before adding them to the stage.

This AI mapping capability adds on to StarfishETL’s pre-existing low code mapping functions, to make it even easier for non-technical users to work with the platform.

AI-Assisted Script Writing

The AI-assisted script writing feature will help users write functions for individual field mappings or global scripts to create pre/post-process procedures. All StarfishETL’s pre-existing scripting language options are supported: C#, VBScript, Javascript, and Python.

The AI model has also been trained on internal ETL scripting functions, including: performing lookups, logging, working with cross-reference lists (Xrefs), and many other features.

To use the AI-assisted scripting, the user enters a prompt for what they want the new function or field mapping to do and provides hints of which fields they expect should be referenced. The AI model does the rest – presenting the user with a complete function to review and approve for their mapping.

AI-Assisted SQL Query Writing

The AI-assisted SQL query writing function within the Origin tab to help users write more complex queries. It can build WHERE clauses, perform JOINs across multiple tables, and use built-in SQL functions to perform translations on the SQL side to streamline the mapping experience.

The user provides a plain language prompt of which data they want returned, adding hints of which tables they’ll be pulling from, and StarfishETL then feeds the schema for those tables into the AI request. The response is a full SQL SELECT statement which users can review and approve for their Origin query. These queries can be tested and modified as the user wishes.

StarfishETL applies these AI capabilities using Amazon’s AI platform, which is powered by the latest AI models available.

“Our goal has always been to simplify the integration process, and by adding AI-assisted scripting, query writing, and field mapping to our platform, we’re empowering users to work faster and with greater accuracy,” says Aron Hoekstra, Lead Developer for StarfishETL. “This new feature reduces manual effort, accelerates project timelines, and makes complex integrations more accessible for teams of all skill levels.”

StarfishETL offers connections to 400+ applications. The platform is well received by analysts and business users for its ease-of-use, scalability, and performance. These new AI features will be available starting October 1, 2024. To request a demo of StarfishETL’s new AI-assisted features, or to get a quote for your next project, please reach out to our sales team at sales@starfishetl.com.

About StarfishETL

StarfishETL is a feature-rich iPaaS for cloud-to-cloud, hybrid, and on-premises deployed solutions. The platform has been recognized by various consumer review sites for its excellent user experience and high performance. The scalable platform supports integration and migrations ranging from small to enterprise-sized businesses and is backed by partners across the world. To learn more about StarfishETL, please visit the website at www.starfishetl.com.

Press Contact:
Danine Midura
8476553415
Starfish ETL | Starfish ETL

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SOURCE StarfishETL

Technology

Introducing Perceptive: A New Name for the Global Leader in Discovery, eClinical, and Imaging Services and Solutions

Published

59 seconds ago

September 30, 2024

Calyx and Invicro rebrand, usher in a new era of leadership and support to the biopharmaceutical community

NOTTINGHAM, England, Sept. 30, 2024 /PRNewswire/ — Calyx and Invicro businesses officially launched under its new corporate identity, Perceptive. The new name reflects the organization’s increased strengths and capabilities, as they consolidate their place as a global leader in the provision of discovery, imaging, and eClinical solutions and services.

New identity reflects the company’s 50-year history and increased strengths in supporting the complete R&D lifecycle

Expanding on their combined 50 + -year history, Perceptive provides best-in-class specialist support to global pharmaceutical, biotech, and clinical research organizations, spanning the complete R&D lifecycle, from discovery and preclinical through clinical development to post marketing. Perceptive’s offerings include imaging biomarkers and core lab services, as well as innovative technologies in randomization and trial supply management (RTSM), analytics and software.

“Today marks a major milestone for Perceptive, as we advance our mission to serve science. We are committed to delivering the diligence, drive, and innovation today that will enable the global clinical research community to realize tomorrow’s new therapies,” said Perceptive CEO, David Herron. “We’re honoured to be part of the global healthcare solution by providing unmatched scientific and technological expertise, global operational experience, and end-to-end solutions that ensure confident R&D decision-making.”

Guided by values of customer-centricity, quality, and accountability, and with global reach across the US, Europe, and Asia, Perceptive aims to bring new insight and understanding to today’s biopharmaceutical industry by supporting researchers across three key areas:

Perceptive Discovery – identify the most promising candidate compounds and minimize risk on the path to clinical success with our collaborative approach to premier preclinical and first-in-human imaging services.

Perceptive eClinical – optimize patient and clinical supply management through the alliance of expertise, innovation, and agility.

Perceptive Imaging – advance novel therapies with scientific, regulatory, and global operational expertise that drives efficient and high-quality data across small and large-scale clinical trials.

Perceptive’s expertise is reflected in the support of almost 12,000 clinical research trials and 800+ approvals to date, across all clinical phases and therapeutic areas, with concentrated expertise in oncology and neuroscience. Moving forward under its new name, Perceptive will continue to serve science by delivering clarity and consistency for clinical trials worldwide on delivery, speed, and results.

To find out more, visit http://www.perceptive.com.

About Perceptive
Perceptive is a leading global technology-enabled service provider for preclinical and clinical trial imaging and IRT/RTSM (Interactive Response Technology/Randomized Trial Supply Management) for drug developers and the global clinical research community. Perceptive’s market-leading service, scientific knowledge, expertise, and technology offering help speed up the delivery of life-saving treatments to millions of patients around the world by accelerating and improving clinical trial outcomes. With operations in the US, Europe, the UK and Asia, the company provides 24/7 services to most of the world’s leading pharma and biotech companies.

Visit Perceptive.com and follow Perceptive on LinkedIn

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SOURCE Perceptive

Technology

CleanSpark Provides Update on Hurricane Helene

Published

1 min ago

September 30, 2024

Employees and infrastructure are safe

LAS VEGAS, Sept. 30, 2024 /PRNewswire/ — CleanSpark Inc. (Nasdaq: CLSK), America’s Bitcoin Miner® (the “Company”) today provided comments and updates on the impact of Hurricane Helene.

Statement from CEO Zach Bradford

In the wake of Hurricane Helene’s destructive path across the Southeastern United States, we extend our deepest condolences to the communities, families, and individuals who have suffered loss, damage, and disruption due to this catastrophic event. We recognize the immense challenges faced by those in regions where the storm has left countless without power, water, and other basic necessities. The loss of life, including first responders who bravely served during this crisis, underscores the severity of Helene’s impact. Our thoughts are with every person whose life has been altered by this hurricane.

The communities in rural Georgia, where our employees and their families reside and where we operate, have experienced this firsthand. The resilience shown by the affected communities and our employees, as they come together to support one another is a testament to the human spirit’s indomitable nature. Our teams have been working hand in hand with the local utilities to mutually support the efforts to bring power back online to regions affected. Their grit and commitment have been outstanding.

I want to extend our deepest gratitude to our incredible teams who have demonstrated remarkable resilience and dedication in the face of this challenge. Your unwavering commitment to excellence, even under trying circumstances, has not gone unnoticed. The spirit of collaboration, grit, and perseverance you’ve shown is truly commendable. Thank you for your hard work, your adaptability, and for pushing through adversity with such determination. We continue to move forward and achieve our goals because of your efforts.

Most importantly, all our team members are safe. Additionally, our geographically diverse portfolio of sites allowed us to maintain approximately 10.5 EH/s at our sites in Northwest Georgia, Mississippi, and Tennessee throughout the storm. To ensure health and safety, and to avoid any undue pressure on the electrical grid, we shut 365 MW of our Southeast Georgia sites down as the hurricane began impacting the region.

Since then, we have been in regular communication with the local utilities to safely bring up the sites in a manner that ensured the local community was supported throughout the process. Within 24 hours, we were able to bring hashrate back to over 17.5 EH/s. We have now brought approximately 200 MW back online and expect to bring the remaining 165 MW online in the coming week after the utilities and communities around us receive power. The majority of the 165 MW remaining offline is projected to be restored to communities no later than October 4, 2024. Our teams are prepared to promptly restore normal operations as soon as power becomes available.

We have also thoroughly evaluated all of our sites and are pleased to report that we have experienced no material damage to any site infrastructure. We are not aware of any material losses related to our mining servers and will continue this evaluation as we energize the remaining sites. Our hashrate is currently at approximately 22 EH/s. When our sites are fully reenergized, we expect to reach standard operations at approximately 28 EH/s.

About CleanSpark
CleanSpark (Nasdaq: CLSK) is America’s Bitcoin Miner®. We own and operate multiple data centers that primarily run on low-carbon power. Our infrastructure responsibly supports Bitcoin, the world’s most important digital commodity and an essential tool for financial independence and inclusion. We cultivate trust and transparency among our employees and the communities we operate in. Visit our website at www.cleanspark.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In this press release, forward-looking statements include, but may not be limited to, statements regarding the Company’s expectations, beliefs, plans, intentions, and strategies. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “could,” “intends,” “targets,” “projects,” “contemplates,” “believes,” “estimates,” “forecasts,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to: the timing of power being restored, potentially unknown damage due to the storm; the timing of energization of the storm affected data centers; anticipated additions and targets to CleanSpark’s hashrate and the timing thereof; the risk that the electrical power available to our facilities does not increase as expected; the success of its digital currency mining activities; the volatile and unpredictable cycles in the emerging and evolving industries in which we operate; increasing difficulty rates for bitcoin mining; bitcoin halving; new or additional governmental regulation; the anticipated delivery dates of new miners; the ability to successfully deploy new miners; the dependency on utility rate structures and government incentive programs; dependency on third-party power providers for expansion efforts; the expectations of future revenue growth may not be realized; and other risks described in the Company’s prior press releases and in its filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2023, and any subsequent filings with the SEC. Forward-looking statements contained herein are made only as to the date of this press release, and we assume no obligation to update or revise any forward-looking statements as a result of any new information, changed circumstances or future events or otherwise, except as required by applicable law.

Investor Relations Contact
Brittany Moore
702-989-7693
ir@cleanspark.com

Media Contact
Eleni Stylianou
702-989-7694
pr@cleanspark.com

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SOURCE CleanSpark, Inc.