Blood culture

T2 Biosystems Announces FDA 510(k) Submission to Expand Use of the FDA-Cleared T2Candida Panel to Include Pediatric Testing

Retrieved on: 
Wednesday, January 3, 2024

The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida pathogens directly from blood, in just 3-5 hours, without the need to wait days for a positive blood culture.

Key Points: 
  • The T2Candida Panel is the only FDA-cleared diagnostic test able to detect sepsis-causing Candida pathogens directly from blood, in just 3-5 hours, without the need to wait days for a positive blood culture.
  • The T2Candida Panel runs on the FDA-cleared T2Dx® Instrument and simultaneously detects five Candida species – including Candida albicans, Candida tropicalis, Candida parapsilosis, Candida krusei, and Candida glabrata.
  • The study also found a higher detection rate with the T2Candida Panel as six additional probable or possible fungal bloodstream infections in pediatric patients were detected by the T2Candida Panel and missed by blood culture.
  • T2Candida was the only test recommended for individual use as a tool for the diagnosis of invasive candidiasis in at-risk children and adolescents.

Accelerate Diagnostics Announces Collaboration for the Use of the Arc™ System in Combination With Bruker´s MALDI Biotyper®

Retrieved on: 
Monday, November 27, 2023

TUCSON, Ariz., Nov. 27, 2023 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ: AXDX) an innovator of rapid in vitro diagnostics in microbiology, announced the signing of a collaboration and quality agreement with Bruker Corporation (NASDAQ: BRKR), the provider of the market-leading MALDI Biotyper system for microbial identification. This agreement enables both companies to validate the use of Accelerate Diagnostics' Arc™ system, an innovative, automated positive blood culture sample preparation platform, with Bruker's MALDI Biotyper® sirius instruments and Sepsityper® software for subsequent registration in both the US and EMEA markets.

Key Points: 
  • Designed for clinical laboratories, the Arc™ system has a simple load-and-go workflow that automates direct from positive blood culture sample preparation for downstream microbial identification using Bruker's MALDI Biotyper system.
  • The Arc™ system enables on-demand processing of samples without the need for an overnight culture incubation, reducing the wait time for identification results.
  • "The combination of Bruker's MALDI Biotyper with Accelerate Diagnostics' Arc™ system to automate positive blood culture sample preparation and rapid microbial identification will be a valuable addition to many laboratories.
  • Bruker welcomes this collaboration with Accelerate Diagnostics as both companies are committed to help laboratories in the important fight against sepsis with their leading products" said Wolfgang Pusch, President, Bruker Microbiology & Infection Diagnostics.

Magnolia Medical Technologies Marks World AMR Awareness Week by Recognizing the Need to Reduce Antibiotic Usage through Accurate Blood Culture Results

Retrieved on: 
Monday, November 20, 2023

SEATTLE, Nov. 20, 2023 /PRNewswire/ -- In observance of World AMR Awareness Week (WAAW), Magnolia Medical Technologies, Inc., the inventors of the Steripath® Initial Specimen Diversion Device® (ISDD®) and the ISDD market to prevent false-positive sepsis tests, is driving efforts to highlight the role of diagnostic stewardship in combating the risk of AMR.

Key Points: 
  • Accurate blood culture results prevent patients from receiving unnecessary, prolonged, and potentially harmful antibiotic therapies, and associated preventable clinical complications, including acute kidney injury, Clostridioides difficile infection (CDI), and multidrug-resistant organism (MDRO) infections.
  • We recently completed a survey of over 1,000 Americans that highlighted the public and medical community's concern with the issue of AMR."
  • Magnolia Medical is encouraging everyone to "Go Blue" from November 18 to 24 to raise awareness for AMR and the need for continued education of this issue.
  • Please visit VoicesofSepsis.org to encourage action from your congressional representatives to support patient safety measures that also help combat the threat of AMR.

Oxford Nanopore and Day Zero Diagnostics Partner to Develop a New Class of Bloodstream Infection Diagnostics

Retrieved on: 
Tuesday, November 14, 2023

According to the World Health Organization (WHO), there are 11 million sepsis-related deaths every year, accounting for one in five deaths worldwide.

Key Points: 
  • According to the World Health Organization (WHO), there are 11 million sepsis-related deaths every year, accounting for one in five deaths worldwide.
  • Early and effective treatment is paramount in a severe infection because the risk of mortality can increase by the hour.
  • "We are pleased to launch this collaboration with Oxford Nanopore that integrates nanopore sequencing innovations with Day Zero Diagnostics' platform technologies to develop a first-of-its kind diagnostic solution for sepsis," said Jong Lee, CEO and co-founder of Day Zero Diagnostics.
  • "We are excited to partner with Day Zero Diagnostics to bring the benefits of nanopore sequencing to fight bloodstream infections," said Gordon Sanghera, CEO of Oxford Nanopore Technologies.

T2 Biosystems Highlights New Clinical Data Presented at IDWeek 2023 Conference

Retrieved on: 
Tuesday, October 24, 2023

LEXINGTON, Mass., Oct. 24, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today highlighted four new studies supporting the T2Bacteria® Panel, the T2Candida® Panel and the T2Resistance® Panel that were recently presented at the IDWeek conference in Boston, Massachusetts.

Key Points: 
  • LEXINGTON, Mass., Oct. 24, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today highlighted four new studies supporting the T2Bacteria® Panel, the T2Candida® Panel and the T2Resistance® Panel that were recently presented at the IDWeek conference in Boston, Massachusetts.
  • The data demonstrates the speed, accuracy and clinical benefits of the T2Dx® Instrument and T2 Biosystems’ sepsis panels and early analytical data on the T2Resistance Panel.
  • “We are encouraged by our latest clinical results as they showcase the critical detection capabilities of both our instrument and sepsis test panels.
  • Adding to our clinical data library and increasing awareness of the clinical and economic benefits of our technology is an important part of our commercial strategy," said John Sperzel, Chairman and CEO of T2 Biosystems.

Kurin, Inc. Reports Record Revenue for Q3 2023

Retrieved on: 
Thursday, October 5, 2023

Kurin, Inc., the inventor and manufacturer of Kurin® blood culture collection sets, announced record revenues for the third quarter of 2023.

Key Points: 
  • Kurin, Inc., the inventor and manufacturer of Kurin® blood culture collection sets, announced record revenues for the third quarter of 2023.
  • In spite of 2023’s economic challenges for hospitals and other adverse market conditions, revenue growth in Q3 was significantly higher than Q2 of this year and when compared to the same period last year.
  • Kurin Lock® and Kurin Jet™ both sideline potential contaminants during blood culture collection and provide a better and more sustainable approach than active, conventional mechanical diversion.
  • Kurin Lock and Kurin Jet give clinicians the tools they need to address these problems.

In Recognition of Sepsis Awareness Month, Magnolia Medical Intensifies Efforts to Combat the Clinical and Economic Risks of Sepsis Misdiagnosis

Retrieved on: 
Thursday, September 7, 2023

SEATTLE, Sept. 7, 2023 /PRNewswire/ -- Magnolia Medical Technologies, Inc., the inventors of the Steripath® Initial Specimen Diversion Device® (ISDD®) and the ISDD market, is intensifying efforts to combat sepsis misdiagnosis this Sepsis Awareness Month. In recognition of the far-reaching implications of an inaccurate sepsis test result, including the risk of accelerating antimicrobial resistance (AMR), the company is committed to raising awareness through peer-reviewed scientific data and programmatic education.

Key Points: 
  • "Sepsis is not just a medical emergency; it's a societal crisis that exacts a terrible toll on patients and the healthcare system, alike.
  • Sepsis Awareness Month is of particular significance to Magnolia Medical.
  • This is a critical issue that requires immediate attention," said Tammy Johnson, AVP, Clinical Strategy at Magnolia Medical.
  • Magnolia Medical is sponsoring a webinar at the 2023 Sepsis Alliance Summit , titled "State of Sepsis Awareness 2023," on September 28th.

T2 Biosystems Praises CDC’s Actions Aimed at Optimizing U.S. Hospital Sepsis Programs

Retrieved on: 
Monday, August 28, 2023

LEXINGTON, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today praised actions taken by the U.S. Centers for Disease Control and Prevention (CDC) aimed at optimizing hospital sepsis programs in the United States.

Key Points: 
  • LEXINGTON, Mass., Aug. 28, 2023 (GLOBE NEWSWIRE) -- T2 Biosystems, Inc. (NASDAQ:TTOO), a leader in the rapid detection of sepsis-causing pathogens and antibiotic resistance genes, today praised actions taken by the U.S. Centers for Disease Control and Prevention (CDC) aimed at optimizing hospital sepsis programs in the United States.
  • The CDC’s newly-released Hospital Sepsis Program Core Elements is intended to help hospitals implement, monitor, and optimize sepsis programs and improve survival rates.
  • The program includes seven elements: Hospital Leadership Commitment, Accountability, Multi-Professional Expertise, Action, Tracking, Reporting, and Education.
  • One in three people who dies in a hospital has sepsis during that hospitalization.

OpGen’s Subsidiary Curetis and FIND Extend R&D Collaboration Agreement

Retrieved on: 
Thursday, August 3, 2023

This extended R&D collaboration now covers the development of an AMR assay and Unyvero A30 cartridge for AMR detection from commonly used blood culture bottles as well as the corresponding software plugin development and full analytical performance evaluation.

Key Points: 
  • This extended R&D collaboration now covers the development of an AMR assay and Unyvero A30 cartridge for AMR detection from commonly used blood culture bottles as well as the corresponding software plugin development and full analytical performance evaluation.
  • Andreas Boos, Chief Technology Officer at Curetis GmbH and program manager for the Unyvero A30 platform development commented, “We are excited to begin working on this new contract and continue our collaboration project.
  • We are focused on making sure diagnostics are accessible to prevent further development of AMR.
  • The Unyvero A30 platform and the AMR test being developed on it has the potential to meet the requirements for use in low- and middle-income countries.

Immunexpress and University Hospitals Cleveland Medical Center Present Quality Improvement Feasibility with SeptiCyte® RAPID at the 2023 American Association for Clinical Chemistry Annual Scientific Meeting and Clinical Lab Expo

Retrieved on: 
Tuesday, July 25, 2023

SEATTLE and BRISBANE, Australia, July 25, 2023 /PRNewswire/ -- Immunexpress, Pty Ltd., a molecular diagnostic company focused on improving outcomes for suspected sepsis patients, announced today a poster presentation by collaborators at University Hospitals Cleveland Medical Center at the 2023 American Association for Clinical Chemistry (AACC) Annual Scientific Meeting and Clinical Lab Expo that demonstrated the feasibility  for quality improvement using SeptiCyte RAPID in patients suspected of sepsis. The poster, entitled "Laboratory Evaluation of the SeptiCyte RAPID Host Response Assay in Differentiating Infection-Positive Versus Infection Negative Systemic Inflammation Patients Suspected of Sepsis," is designated as Poster #A-384 and will be displayed in Session A, Point of Care Testing, on Tuesday, July 25, from 1:30 – 2:30 p.m. PT, in Anaheim, California.

Key Points: 
  • "The early accurate diagnosis of sepsis can be challenging, but recent advancements in FDA-cleared lab tests have introduced new tools that may enhance earlier diagnosis.
  • Chair and Distinguished Scientist in Cardiovascular Research at University Hospitals in Cleveland/Case Western Reserve University.
  • "We utilized the SeptiCyte RAPID test in a quality improvement fashion and demonstrated its ease of use for real time sepsis practice.
  • "This further shows that SeptiCyte RAPID can deliver timely and precise results in about one hour from when the lab receives the blood draw.