Marie Cassidy

Akero Therapeutics Reports Statistically Significant Histological Improvements at Week 96 in Phase 2b HARMONY Study

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월요일, 3월 4, 2024

SOUTH SAN FRANCISCO, Calif., March 04, 2024 (GLOBE NEWSWIRE) --  Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic disease marked by high unmet medical need, today released preliminary topline week 96 results from HARMONY, a Phase 2b study evaluating the efficacy and safety of its lead product candidate efruxifermin (EFX) in patients with pre-cirrhotic metabolic dysfunction-associated steatohepatitis (MASH), fibrosis stage 2 or 3 (F2-F3). The study previously met its primary endpoint of ≥1 stage improvement in fibrosis with no worsening of MASH after 24 weeks of treatment for both the 50mg EFX (41%) and 28mg EFX (39%) dose groups, compared to 20% for the placebo arm. At week 96, the response rates on this endpoint increased to 75% (p

Key Points: 
  • Specifically, the placebo-adjusted effect sizes for fibrosis improvement without worsening of MASH grew from 21% to 52% between week 24 and week 96 for 50mg EFX and from 20% to 22% for 28mg EFX.
  • Highly statistically significant results for 50mg EFX at week 96 are notable because (1) the study was not fully powered at week 96 and (2) the placebo rate increased rather than decreased.
  • Analysis of the evolution of responses between weeks 24 and 96 indicated not only broader fibrosis improvement without worsening of MASH but also sustained response, particularly at 50mg EFX.
  • Among those patients with available week 96 biopsies whose fibrosis improved at week 24, 92% and 83% of the 50mg and 28mg EFX groups remained responders, respectively, compared to 40% for placebo.

Pramana Joins Proscia Ready To Help Laboratories Realize More Value From Their Pathology Data

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화요일, 2월 27, 2024

and PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Proscia® , a leading provider of digital and computational pathology solutions, today announced that Pramana, Inc. , an AI-enabled health tech company modernizing the pathology sector, is now a Proscia Ready partner.

Key Points: 
  • and PHILADELPHIA, Feb. 27, 2024 (GLOBE NEWSWIRE) -- Proscia® , a leading provider of digital and computational pathology solutions, today announced that Pramana, Inc. , an AI-enabled health tech company modernizing the pathology sector, is now a Proscia Ready partner.
  • Pramana joins the partner alliance to help life sciences organizations and diagnostic laboratories increasingly leverage enriched, high-quality data, including DICOM images, in their routine research and clinical operations.
  • Proscia Ready was established to help laboratories accelerate the scaled adoption of digital pathology with confidence.
  • To learn more, visit Proscia at booth 200 and Pramana at booth 549 during the upcoming United States and Canadian Academy of Pathology (USCAP) 113th Annual Meeting.

ProPhase Labs Announces Significant Progress in BE-Smart Esophageal Cancer Test Development USPTO grants additional broad patents for BE-SMART

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화요일, 2월 20, 2024

This breakthrough test, in development for nearly five years, is nearing completion of clinical studies.

Key Points: 
  • This breakthrough test, in development for nearly five years, is nearing completion of clinical studies.
  • If the clinical trial results are successful, the Company will be aiming for commercial launch during 2024.
  • Recently, an additional 139 specimens were analyzed in collaboration with The Mayo Clinic, for the purposes of assessing the test's precision and reliability in identifying esophageal adenocarcinoma risk.
  • - The test has demonstrated molecular precision in excess of 99%1, which is a remarkably precise accomplishment in cancerous tissue analysis.

Physicians' Education Resource® announces exciting initiative at the 41st Annual Miami Breast Cancer Conference®

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월요일, 2월 19, 2024

CRANBURY, N.J., Feb. 19, 2024 (GLOBE NEWSWIRE) -- Physicians' Education Resource®, LLC (PER®), a top educational resource for health care professionals across all specialties to advance patient care, is pleased to announce their 41st Annual Miami Breast Cancer Conference® at the Fontainebleau Miami Beach, March 7–10, 2024.

Key Points: 
  • CRANBURY, N.J., Feb. 19, 2024 (GLOBE NEWSWIRE) -- Physicians' Education Resource®, LLC (PER®), a top educational resource for health care professionals across all specialties to advance patient care, is pleased to announce their 41st Annual Miami Breast Cancer Conference® at the Fontainebleau Miami Beach, March 7–10, 2024.
  • This interactive, in-person conference is intended for medical, surgical, and radiation oncologists interested in the treatment of patients with breast cancer.
  • For 40 years, the Miami Breast Cancer Conference has served many educational needs by uniting oncologists—alongside geneticists, pathologists, radiologists, and supportive care specialists—to advance patient care in breast cancer.
  • At this year's Miami Breast Cancer Conference, PER is pleased to announce a special tribute to oncology heroes from esteemed local institutions, including Reshma Mahtani, DO, from Baptist Health Miami Cancer Institute, and Debu Tripathy, MD, from The University of Texas MD Anderson Cancer Center.

New MEDITECH Expanse Pathology Solution Streamlines Pathologist Workflows

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화요일, 2월 20, 2024

MEDITECH announces the release of its redesigned Expanse Pathology solution — one of the company’s latest innovations in its Expanse EHR .

Key Points: 
  • MEDITECH announces the release of its redesigned Expanse Pathology solution — one of the company’s latest innovations in its Expanse EHR .
  • As the pathology industry trends towards more specialized imaging and advanced integrated reporting with genetic results, Expanse Pathology provides the technology pathologists need to assist with the most complicated cases.
  • Designed to support web-native navigation, Expanse Pathology positions laboratories to leverage the latest advancements in the pathology market today and in the future.
  • “MEDITECH Expanse Pathology removes silos by providing pathologists with the tools necessary to increase efficiency and easily communicate information across the entire pathology department and beyond — from OB to Oncology — ensuring timely access to the most relevant information.”
    Visit MEDITECH in booth #2580 at #HIMSS24 to learn more about Expanse Pathology.

Advancing Precision in Barrett's Esophagus and Dysplasia Diagnoses: WATS3D Study Demonstrates Exceptional Consensus Among Pathologists

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수요일, 3월 6, 2024

WATS3D Study Demonstrates Exceptional Consensus Among Pathologists.

Key Points: 
  • WATS3D Study Demonstrates Exceptional Consensus Among Pathologists.
  • This was a collaborative study among gastrointestinal pathologists who have an interest and expertise in Barrett's esophagus.
  • The pathologists were then asked to evaluate digital images from 60 WATS3D cases with BE.
  • "The significant variability among pathologists assessing Barrett's esophagus poses challenges for accurate diagnosis and treatment decisions, complicating patient care."

Ibex and PathPresenter Launch Partnership to Accelerate Adoption of AI-powered Digital Pathology

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수요일, 3월 6, 2024

BOSTON and MONTVILLE, N.J., March 6, 2024 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, and PathPresenter, the global image sharing platform for pathology, today announced a partnership to advance the adoption of AI-powered digital pathology. The two companies will work together to support joint customers via an AI-powered digital pathology solution for laboratories, hospitals and health systems worldwide.

Key Points: 
  • BOSTON and MONTVILLE, N.J., March 6, 2024 /PRNewswire/ -- Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, and PathPresenter , the global image sharing platform for pathology, today announced a partnership to advance the adoption of AI-powered digital pathology.
  • The two companies will work together to support joint customers via an AI-powered digital pathology solution for laboratories, hospitals and health systems worldwide.
  • "The digital pathology and AI transformation that Ibex and PathPresenter are championing is modernizing the industry and providing pathologists with AI tools to improve diagnostic accuracy, lab efficiencies and patient outcomes," said Joseph Mossel, CEO and Co-Founder of Ibex Medical Analytics.
  • "We are committed to working with the best partners to advance digital pathology adoption and education, and Ibex is      a clear leader in AI-powered diagnostics," said Dr. Rajendra Singh, founder of PathPresenter.

Lab Community "Extremely Concerned" About Patient Access to Testing If FDA Regulates Lab-Developed Tests

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화요일, 3월 5, 2024

"If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."

Key Points: 
  • "If labs cannot afford to comply with the proposed regulations, they will have to discontinue essential tests, and that harms patients."
  • To better understand how clinical laboratorians perceive the proposed rule, ARUP Laboratories conducted a survey of the clinical laboratory community.
  • Most respondents identified themselves as lab managers, lab supervisors, lab directors, lab employees, medical directors, pathologists, physicians, clinicians, or PhD scientists.
  • Over a hundred thousand clinical laboratorians dedicate their professional lives to ensuring high-quality testing and patient care every day in the U.S.

CND Life Sciences Partners with Visiopharm on Novel AI-Tool to Detect and Quantify Pathological Alpha-Synuclein in Cutaneous Nerves

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화요일, 3월 5, 2024

SCOTTSDALE, Ariz.., March 5, 2024 /PRNewswire/ -- CND Life Sciences (CND), a medical technology company pioneering the development of cutaneous neurodiagnostic tests and associated biomarker services, today will unveil its NerValence pathology detection system at the AD/PD 2024 conference in Lisbon, Portugal. NerValence, developed through a strategic collaboration with precision pathology company Visiopharm, significantly enhances CND's biomarker testing services for clinical trials targeting the alpha-synuclein protein in patients with suspected Parkinson's disease, dementia with Lewy bodies, and related disorders.

Key Points: 
  • NerValence aids in the identification, tracking, and measuring the volume of alpha-synuclein in cutaneous nerves.
  • NerValence features machine learning algorithms that recognize and differentiate microscopic structures, nerves, and important disease markers that can be found in cutaneous tissue.
  • "Utilizing our novel deep learning technology to power this crucial advancement in neurodegenerative diseases represents a significant leap forward in analyzing peripheral nerves," said Michael Grunkin , Visiopharm Chief Executive Officer.
  • "Collaborating with CND Life Sciences on its deployment of NerValence will continue to be a major priority as we advance AI-driven precision pathology to enhance biopharmaceutical drug development."

Roche enters into collaboration agreement with PathAI to expand digital pathology capabilities for companion diagnostics

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화요일, 2월 13, 2024

PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop artificial intelligence (AI) digital pathology algorithms for RTD's companion diagnostics business.

Key Points: 
  • PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop artificial intelligence (AI) digital pathology algorithms for RTD's companion diagnostics business.
  • The image analysis algorithms will be deployed on Roche's navify Digital Pathology platform, allowing seamless integration into pathology laboratories worldwide.
  • The collaboration between RTD and PathAI helps advance precision medicine by bringing together AI-interpretation and companion diagnostics, increasing patient access to targeted treatments.
  • Under the terms of this agreement, PathAI will exclusively work with Roche Tissue Diagnostics (RTD) to develop AI-enabled digital pathology algorithms in the companion diagnostics space.