Beckman Coulter Partners with Mass General and BARDA to Identify Severe Pediatric Infections in Emergency Departments

Beckman Coulter, global leader in advanced diagnostics, today announced that it will partner with Massachusetts General Hospital to validate the use of the novel Monocyte Distribution Width (MDW) hematology biomarker in rapid identification of children presenting with early signs of severe illness from infection.

Beckman Coulter partners with Mass General and BARDA to validate the use of the novel Monocyte Distribution Width (MDW) hematology biomarker in rapid identification of children presenting with early signs of severe illness from infection.

This pivotal, multi-center trial will receive funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. MDW is currently the only FDA-cleared blood biomarker to aid in detecting adult sepsis in the Emergency Department (ED). This current partnership aims to expand the utility of MDW as a screening tool to measure the severity of infection in children 15 years old and younger presenting with high fevers.

Approximately 25 million children under 15 visit the emergency room every year, and about one in five presents with a fever. 1 The most common cause of fever in these children is infections that can be safely treated at home; however, one out of every four pediatric hospital admissions are due to complications from infection. 2 No objective biomarker yet exists that accurately identifies children at risk of hospitalization from an excessive immune response early in the infectious course when intervention is critical, making clinical decisions in the ED on how to treat pediatric infections difficult.

"A sick, febrile child can be challenging to examine, and current blood tests have limited ability to predict who will progress to acute illness," states Lael Yonker , M.D., a pediatric pulmonologist at Mass General for Children, and co-investigator on this clinical trial.  "Objective tests that are readily available are needed to make sure children get the medical attention they need in a timely manner."

The utility of MDW as a biomarker in pediatric infection was first recognized by Mass General during the height of the COVID-19 pandemic, when more than 400 children a month were developing a life-threatening complication from COVID-19, now termed Multisystem Inflammatory Syndrome in Children (MIS-C).

As published in June 2022 in BMC Infectious Diseases 3 , the team found that MDW can improve the identification of children at high risk of MIS-C complication, a task that has proven challenging to clinicians. 4 Now, this team will join Beckman Coulter and BARDA to potentially expand the use of MDW in the early recognition of severe infections in children presenting to EDs.

Notably, this tool is based on routinely ordered blood tests and can be reported as an additional parameter on Complete Blood Count (CBC) results. This approach may allow ED physicians to make rapid, accurate and safe decisions about which children with infections can go home and which children with infections need to be admitted to the hospital for further treatment without subjecting patients to additional and costly testing.

"We are thrilled to be partnering with pediatricians at Mass General to investigate the utility of MDW in identifying children at risk of adverse outcomes due to infection," said Julie Sawyer Montgomery , president, Beckman Coulter. "Along with the award from BARDA, Beckman Coulter is committing additional funds to this partnership. We are invested in establishing the performance of MDW in the pediatric population and in continuing our commitment to clinical evidence for use of MDW, and other novel hematological biomarkers."

MDW is a regulatory-cleared parameter for adult patients presenting to the ED and is available as a standard component of a CBC performed on Beckman Coulter's DxH 900 and 690T hematology analyzers. The MDW parameter measures the dispersion of monocyte volume in the blood, which is altered during infection due to monocyte activation and subsequent changes in monocyte morphology. Increases in MDW indicate increases in the variability of monocyte morphology, which can indicate a progression from localized to systemic infection.

MDW provides physicians with an early indication of sepsis risk, which is especially important when a patient's symptoms are mild and alternative diagnoses are being considered. MDW is only available on Beckman Coulter platforms.

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50122C00036.

Follow and connect with Beckman Coulter via LinkedIn , Twitter , and Facebook

About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We do this by accelerating care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Beckman Coulter is part of the Danaher Corporation (NYSE:DHR) family of global science and technology companies. Headquartered in Brea, Calif. , it has more than 11,000 global team members.

  1. Cairns C, Kang K, Santo L. National Hospital Ambulatory Medical Care Survey: 2018 emergency department summary tables. Available from: FastStats - Emergency Department Visits (cdc.gov)
  2. Goto T, Tsugawa Y, Mansbach JM, Camargo CA Jr, Hasegawa K. Trends in Infectious Disease Hospitalizations in US Children, 2000 to 2012. Pediatr Infect Dis J . 2016;35(6):e158-e163. doi:10.1097/INF.0000000000001134
  3. Yonker LM, Badaki-Makun O, Arya P, Boribong BP, Moraru G, Fenner B, Rincon J, Hopke A, Rogers B, Hinson J, Fasano A, Lee L, Kehoe SM, Larson SD, Chavez H, Levin S, Moldawer LL, Irimia D. Monocyte anisocytosis increases during multisystem inflammatory syndrome in children with cardiovascular complications. BMC Infect Dis . 2022;22(1):563. doi: 10.1186/s12879-022-07526-9.
  4. Rosu CA, Martens AM, Sumner J, Farkas EJ, Arya P, Arauz AB, Madhavan VL, Chavez H, Larson SD, Badaki-Makun O, Irimia D, Yonker LM. Heterogeneity in the evaluation of suspected MIS-C: a cross-sectional vignette-based survey . BMC Pediatr . 2022;22(1):392. doi: 10.1186/s12887-022-03446-4.

© 2022 Beckman Coulter. All rights reserved. Beckman Coulter, the stylized logo, and the Beckman Coulter product and service marks mentioned herein are trademarks or registered trademarks of Beckman Coulter, Inc. in the United States and other countries. 2022-10652

Beckman Coulter logo. (PRNewsfoto/Beckman Coulter)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/beckman-coulter-partners-with-mass-general-and-barda-to-identify-severe-pediatric-infections-in-emergency-departments-301592342.html

SOURCE Beckman Coulter, Inc.

News Provided by PR Newswire via QuoteMedia

DHR
The Conversation (0)
Discovery Harbour Approved All Resolutions at Annual and Special Meeting

Discovery Harbour Approved All Resolutions at Annual and Special Meeting

Discovery Harbour Resources Corp. (TSXV: DHR) (OTC Pink: DCHRF) (FSE: 4GW) (the "Company" or "Discovery Harbour") shareholders approved all resolutions at the Company's annual and special meeting which was held on May 5, 2023. Details of these matters are disclosed in the management information circular for the meeting dated March 23, 2023, and posted under the company's profile on SEDAR.

At the meeting, shareholders elected the director nominees as listed in the Company's information circular, being Mark Fields, Richard Gilliam, Andrew Hancharyk and Rodney Stevens. The reappointment of Manning Elliott LLP, Chartered Professional Accountants, as auditor of the Company was approved by the shareholders as was the ratification and re-approval of the amended and restated 10% rolling stock option plan.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
ALDEVRON ANNOUNCES EXPANSION OF mRNA PRODUCTION CAPABILITY

ALDEVRON ANNOUNCES EXPANSION OF mRNA PRODUCTION CAPABILITY

Will offer mRNA cGMP Production from Master Cell Bank to Drug Product Made Possible with Precision Nanosystems and Cytiva

Aldevron, a leading global manufacturer of DNA, RNA and proteins used in cell and gene therapies and vaccine development, will expand its mRNA production capabilities to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities enabling mRNA cGMP manufacturing services from Master Cell Bank through to Drug Product. This new capability will support the production of therapeutic-scale clinical and commercial-stage mRNA therapies for cancers and genetic diseases, and clinical-stage vaccines for infectious diseases.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Danaher Reports First Quarter 2023 Results

Danaher Corporation (NYSE: DHR) (the "Company") today announced results for the first quarter 2023. Net earnings refer to net earnings attributable to common shareholders.

For the quarter ended March 31, 2023 net earnings were $1.4 billion , or $1.94 per diluted common share and non-GAAP adjusted diluted net earnings per common share were $2.36 .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

Orchestra BioMed Reports First Quarter 2025 Financial Results and Highlights Recent Regulatory and Clinical Milestones

  • FDA Breakthrough Device Designation Awarded to AVIM Therapy
  • FDA IDE Approved for Virtue SAB U.S. Pivotal Trial for Launch

Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, "Orchestra BioMed" or the "Company"), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced financial results for the first quarter ended March 31, 2025, and provided a business update highlighting continued regulatory momentum, disciplined operational execution, and a strengthening clinical development pipeline.

Q1 2025 Highlights:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic to announce financial results for its fourth quarter and full fiscal year 2025

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that it will report financial results for its fourth quarter and full fiscal year 2025 on Wednesday, May 21, 2025 . A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at https:news.medtronic.com . The news release will include summary financial information for the company's fourth quarter and full fiscal year 2025, which ended on Friday, April 25, 2025 .

Medtronic will host a video webcast at 7:00 a.m. CDT on May 21, 2025 , to discuss results for its fourth quarter and full fiscal year 2025. The webcast can be accessed at https://investorrelations.medtronic.com .

News Provided by Canada Newswire via QuoteMedia

Keep reading...Show less
New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

New survey: 1 in 3 women have not talked to their doctor about heart health, the #1 killer of women

Star Jones , award winning television personality & women's heart health advocate,   helps kick off heart health conversations this Mother's Day with the Medtronic 'Letter to My Mother' campaign

A new Medtronic-sponsored survey of women ages 30-50 reveals a significant gap in awareness and discussion around heart health among women and their mother-figures. Despite cardiovascular disease being the #1 killer of women in the U.S. many women are still unaware of the risk and the importance of heart health.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

Medtronic Affera pulsed field ablation technologies continue to demonstrate promising evidence for atrial fibrillation patients

  • One-year clinical trial data for the next-generation, investigational, Sphere-360™ single-shot PFA catheter show impressive safety, performance, and efficiency results for paroxysmal Afib
  • Dual-energy (RF/PF), focal Sphere-9™ catheter demonstrates efficacy for linear ablation in persistent AFib
  • Medtronic continues legacy of leadership in innovation, showcasing arrhythmia management portfolio at Heart Rhythm Society annual meeting

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera™ family of technologies, including the next-generation Sphere-360™ single-shot pulsed field ablation (PFA) catheter and the groundbreaking Sphere-9™ combination mapping and dual-energy focal PFA catheter. Data were presented in High Impact Science Sessions at the Heart Rhythm Society 2025 Annual Meeting in San Diego ; the Sphere-360 study was simultaneously published in the Heart Rhythm Journal .

(PRNewsfoto/Medtronic plc)

Sphere-360 Study Safety and Performance

Sphere-360 is an investigational, first-of-its-kind, single-shot PFA mapping and ablation catheter for treatment of paroxysmal atrial fibrillation (PAF). Results for Sphere-360 at one year, in a prospective, single-arm, multi-center trial performed in European centers, demonstrated freedom from arrhythmia recurrence in 88% of patients, with chronically durable pulmonary vein isolation (PVI) in 98% of targeted veins and no reported safety events in a sub-group treated with the most optimized waveform. The Sphere-360 catheter has a large, conformable lattice design that can be modified into various shapes, is seamlessly integrated with the Affera Mapping and Ablation System and utilizes an 8.5 Fr sheath – the smallest in any single-shot PFA technology.

"The Affera technology is a sophisticated ecosystem, including an advanced, intuitive mapping system and catheters that are seamlessly integrated to offer treatment options for different cardiac arrhythmias. It is encouraging to see the promising results for Sphere-360, which can easily create circumferential lesions without the need for catheter rotation," said Vivek Reddy , M.D., Director of Cardiac Arrhythmia Services for the Mount Sinai Health System in New York City . "The study results showed Sphere-360 has a promising safety and performance profile with zero serious adverse events observed. Upon approval, Sphere-360 will be a valuable addition to Medtronic's Affera system, which has been a game changer for Afib treatment and physician workflow."

Medtronic intends to begin its U.S. pivotal trial for the Sphere-360 catheter later this calendar year. Worldwide, Sphere-360 is currently investigational and not approved for sale or distribution.

Sphere-9 for Linear Ablation

Additionally, in a sub-analysis from the Sphere Per-AF IDE study , results demonstrated that the Sphere-9 catheter can be used safely and effectively to create linear lesions in persistent AF patients. Linear ablation is often used in conjunction with PVI to improve the chances of restoring a normal heart rhythm without recurrence in persistent AF patients. The Sphere Per-AF IDE study evaluated the safety, efficacy and efficiency of Affera and Sphere-9 in persistent AF and led to the FDA approval of Affera in October 2024 .

"True to our Medtronic mission for patients and legacy of innovation, we are delivering our best-in-class technologies to physicians and improving care for AFib patients, and we are not slowing down," said Rebecca Seidel , president of the Cardiac Ablation Solutions business at Medtronic, which is part of the Cardiovascular portfolio. "These results signify another step forward and energize us as we continue to earn and build our leadership position in electrophysiology every day."

Medtronic is the only company with two PFA offerings for physicians and patients. The PulseSelect™ Pulsed Field Ablation System offers physicians a safe, single-shot solution for pulmonary vein isolation (PVI) and is now available in more than 30 countries. The Affera system together with the Sphere-9 catheter enables physician treatment flexibility with its wide area focal design and 9mm lattice tip that can used with an 8.5Fr sheath. Affera is available in Europe , Australia and New Zealand , with global expansion ongoing.

AFib is one of the most common and undertreated heart rhythm disorders, affecting more than 60 million people worldwide. 1 Afib is a progressive disease, often beginning as paroxysmal AFib (presents intermittently) and progressing to persistent (lasts for more than 7+ days without stopping). As the disease progresses, the risk of serious complications including heart failure, stroke and risk of death increases 2-5 .

For more information on the Affera PFA system and the Sphere-9 catheter, visit Medtronic.com.

About Medtronic

Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway , Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE: MDT), visit www.Medtronic.com and follow Medtronic on LinkedIn .

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

References

  1. Roth GA, Mensah GA, Johnson CO et al. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol 2020;76:2982-3021.
  2. Miyasaka Y, Barnes ME, Bailey KR, et al. Mortality trends in patients diagnosed with first atrial fibrillation: a 21-year community-based study. J Am Coll Cardiol 2007;49:986-92.
  3. Hindricks G, Potpara T, Dagres N, et al. 2020 ESC Guidelines for the diagnosis and management of atrial fibrillation developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS). Eur Heart J 2020.
  4. Wolf PA , Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991;22:983-8.
  5. Lubitz SA, Moser C, Sullivan L, et al. Atrial fibrillation patterns and risks of subsequent stroke, heart failure, or death in the community. J Am Heart Assoc 2013;2:e000126

Dr. Reddy is a paid consultant for Medtronic.

Contacts:
Leslie Williamson
Public Relations
+1-612-227-5099

Ryan Weispfenning
Investor Relations
+1-763-505-4626

View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-affera-pulsed-field-ablation-technologies-continue-to-demonstrate-promising-evidence-for-atrial-fibrillation-patients-302439006.html

SOURCE Medtronic plc

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Medtronic Expand URO U.S. clinical trial meets safety and effectiveness primary endpoints for Hugo robotic-assisted surgery system

Largest multi-center prospective Investigational Device Exemption (IDE) study for multi-port robotic-assisted urologic surgery   in the U.S. presented as a late-breaker at the American Urologic Association annual meeting

Company confirms Hugo RAS system submission to the U.S. Food and Drug Administration

Medtronic (NYSE: MDT), a global leader in healthcare technology, today announced that the Expand URO Investigational Device Exemption (IDE) clinical study, the largest such study for robotic-assisted urologic surgery ever conducted, met both primary safety and effectiveness endpoints. The prospective, multi-center, single-arm IDE study included 137 patients who underwent urologic procedures using the Hugo™ robotic-assisted surgery (RAS) system.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Medtronic receives FDA approval for smallest-diameter, lumenless defibrillation lead, the OmniaSecure lead and announces investigational clinical study results

Adding to the Medtronic portfolio of catheter-based lead solutions, the novel OmniaSecure defibrillation lead allows for precise delivery and placement in the right ventricle

Heart Rhythm 2025: Late-breaking clinical study results evaluating the OmniaSecure lead for investigational use in the LBBAP location show high defibrillation success

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×