Archives of Pathology & Laboratory Medicine

Visiopharm and Boston Cell Standards Announce Partnership to Develop Joint IHC Technology for Magnani-Taylor Regulatory Proposal

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Martedì, Agosto 15, 2023

“The higher proposed assay requirements will raise the quality of IHC testing to ensure accurate results, which will benefit pathologists, oncologists and, ultimately, patients,” said Dr. Steven Bogen, CEO, Boston Cell Standards. “However, aligning IHC laboratory testing globally requires that labs have access to enabling quality assurance tools that, until recently, were not available -- calibration standards and image analysis quantification software to measure the calibrator test results.”

Key Points: 
  • Visiopharm and Boston Cell Standards today announced a partnership to develop a joint technology solution that enables labs to meet key provisions of regulatory changes proposed in a groundbreaking editorial recently published in Archives of Pathology & Laboratory Medicine.
  • If adopted, the proposal would represent a significant shift in the IHC lab regulatory landscape, requiring labs to incorporate rigorous assay control methods and calibration.
  • Modern clinical laboratory quality assurance protocols include reference standards, assay calibration, quantitative controls, and standardized units of measure.
  • Visiopharm developed Qualitopix™, a groundbreaking AI-driven image analysis software for IHC assay control quantification and tracking (Levey-Jennings analysis).

Histolix Team Receives Additional $3.2 Million Funding for Revolutionary Direct-to-Digital Read Pathology Solution Development

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Mercoledì, Giugno 28, 2023

The latest grant brings the total of funding awarded to the Histolix founding team to $9 million from the NCI and National Institute of Health (NIH) over the past 12 months.

Key Points: 
  • The latest grant brings the total of funding awarded to the Histolix founding team to $9 million from the NCI and National Institute of Health (NIH) over the past 12 months.
  • The development effort of this revolutionary new histological methodology is being led by renowned UCD experts Richard Levenson, MD and Farzad Fereidouni, PhD.
  • "We believe Histolix could reduce or eliminate breast lumpectomy re-excision procedures resulting from inadequate margin analysis by current technologies.
  • Today, 25 percent of women are found to have incomplete cancer excision and need to have a second surgery," said Rob Royea, president and CEO, Histolix.

CAP and ASCO Reaffirm Current HER2 Testing Guidelines, Reducing Confusion

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Mercoledì, Giugno 7, 2023

The College of American Pathologists (CAP) and American Society of Clinical Oncology (ASCO) have reaffirmed the Human Epidermal Growth Factor Receptor 2 (HER2) Breast Cancer Testing Guidelines, reducing confusion over terminology for reporting HER2 results.

Key Points: 
  • The College of American Pathologists (CAP) and American Society of Clinical Oncology (ASCO) have reaffirmed the Human Epidermal Growth Factor Receptor 2 (HER2) Breast Cancer Testing Guidelines, reducing confusion over terminology for reporting HER2 results.
  • After reviewing results of the DESTINY-Breast04 trial and other studies, the CAP/ASCO panel determined that the current HER2 testing recommendations remain valid to identify all breast cancer patients who might benefit from the full spectrum of HER2 related therapies.
  • “It used the current CAP/ASCO testing algorithm for HER2 protein expression levels.
  • Current tools, resources, and information for the CAP/ASCO HER2 Guideline & Guideline Update can be found on the HER2 Testing in Breast Cancer guideline webpage on cap.org.

Biopsy Devices Market Predicted to Achieve Striking Growth of USD 3.96 Billion with Healthy CAGR of 7.3% by 2029, Size, Share, Trends, Demand and Competitive Analysis

Retrieved on: 
Martedì, Marzo 7, 2023

To Check the Complete Table of contents, click here @ https://www.databridgemarketresearch.com/toc/?dbmr=global-biopsy-devices...

Key Points: 
  • To Check the Complete Table of contents, click here @ https://www.databridgemarketresearch.com/toc/?dbmr=global-biopsy-devices...
    North America Biopsy Devices Market , By Product (Needle-Based Biopsy Instruments, Procedure Trays, Localization Wires and other Products), Application (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy and Other Applications), Guidance Technique (Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, MRI-Guided Biopsy and Other Guidance Techniques), End User (Hospitals, Academic and Research Institutes, Diagnostic and Imaging Centers), and Country (U.S., Canada, Mexico) https://www.databridgemarketresearch.com/reports/north-america-biopsy-de...
    Europe Biopsy Devices Market , By Product (Needle-Based Biopsy Instruments, Procedure Trays, Localization Wires and other Products), Application (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy and Other Applications), Guidance Technique (Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, Mri-Guided Biopsy and Other Guidance Techniques), End User (Hospitals, Academic and Research Institutes, Diagnostic and Imaging Centers), and Country https://www.databridgemarketresearch.com/reports/europe-biopsy-devices-m...
    Asia-Pacific Biopsy Devices Market By Product (Needle-Based Biopsy Instruments, Procedure Trays, Localization Wires and Other Products), Guidance Technique (Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, MRI-Guided Biopsy and Other Guidance Techniques), Application (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy and Other Applications), End User (Hospitals, Academic and Research Institutes, Diagnostic and Imaging Centres), Country https://www.databridgemarketresearch.com/reports/asia-pacific-biopsy-dev...
    Breast Biopsy Devices Market , By Product (Biopsy Needles, Biopsy Tables, Biopsy Wires, Guidance Systems, Others), Technique Type (Fine Needle Aspiration Biopsy, Core Needle Biopsy, Biopsy Markers, MRI-Guided Core Needle Biopsy, Surgical Biopsy, Wire Localization, Sentinel Node Biopsy), Guidance Technology (Fine Ultrasound-Guided, Mammography-Guided Magnetic Resonance, CT-Guided Biopsy, Other Image-Guided Breast Biopsy), End User (Hospitals, Ambulatory Surgical Centers, Diagnostic Centers, Other) https://www.databridgemarketresearch.com/reports/global-breast-biopsy-de...
    North America Breast Biopsy Devices Market , By Product (Biopsy Needles, Biopsy Tables, Biopsy Wires, Guidance Systems and Others), Technique Type (Fine Needle Aspiration Biopsy, Core Needle Biopsy, Biopsy Markers, MRI-Guided Core Needle Biopsy, Surgical Biopsy, Wire Localization and Sentinel Node Biopsy), Guidance Technology (Fine Ultrasound-Guided, Mammography-Guided Magnetic Resonance, CT-Guided Biopsy and Other Image-Guided Breast Biopsy), End User (Hospitals, Ambulatory Surgical Centers, Diagnostic Centers and Other), and Country (U.S., Canada, Mexico) https://www.databridgemarketresearch.com/reports/north-america-breast-bi...
    Europe Breast Biopsy Devices Market , By Product (Biopsy Needles, Guidance Systems, Biopsy Tables, Localization Wires, Assay Kits, Liquid Biopsy Instruments, Others), Type (Needle Breast Biopsy, Open Surgical Breast Biopsy, Liquid Breast Biopsy, Other Biomarkers), Guidance (Image-Guided Biopsy, Liquid Biopsy, Other Guidance Techniques), Application (Early Cancer Screening, Therapy Selection, Treatment Monitoring, Recurrence Monitoring), Country https://www.databridgemarketresearch.com/reports/europe-breast-biopsy-de...
    Asia-Pacific Breast Biopsy Devices Market , By Product (Biopsy Needles, Biopsy Tables, Biopsy Wires, Guidance Systems, Others), Technique Type (Fine Needle Aspiration Biopsy, Core Needle Biopsy, Biopsy Markers, MRI-Guided Core Needle Biopsy, Surgical Biopsy, Wire Localization, Sentinel Node Biopsy), Guidance Technology (Fine Ultrasound-Guided, Mammography-Guided Magnetic Resonance, CT-Guided Biopsy, Other Image-Guided Breast Biopsy), End User (Hospitals, Ambulatory Surgical Centers, Diagnostic Centers, Other), Country https://www.databridgemarketresearch.com/reports/asia-pacific-breast-bio...
    Smart Biopsy Devices Market , By Application (Breast Cancer, Skin Cancer, Liver Cancer, Prostate Cancer, Others), Product (Needle-Based Biopsy Instruments, Procedure Trays, Localization Wires, Other Products), Guidance Technique (Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, Magnetic Resonance Imaging-Guided Biopsy, Other Guidance Techniques), End User (Hospitals, Academic and Research Institutes, Diagnostic and Imaging Centers) Country https://www.databridgemarketresearch.com/reports/global-smart-biopsy-dev...
    Vacuum Assisted Biopsy Devices Market , By Product (Vacuum-assisted Biopsy Systems, Vacuum-assisted Biopsy Needles), Type (9-12G, 12G), Technique (Ultrasound-guided Biopsy, Stereotactic-guided Biopsy, MRI-guided Biopsy, Others), Applications (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy, and Others), End User (Hospitals, Academic and Research Institutes, Diagnostic and Imaging Centers, Others) https://www.databridgemarketresearch.com/reports/global-vacuum-assisted-...
    Endobronchial Ultrasound Biopsy Devices Market , By Product (Biopsy Forceps, Cytology Brushes, Biopsy Needles, Trans bronchial Aspiration Needles, Spray Catheters, Others), Application (Cancer Diagnosis, Infection Diagnosis, Others), Country https://www.databridgemarketresearch.com/reports/global-endobronchial-ul...
    Liquid Biopsy Market , By Sampling Type (Blood Sampling Liquid Biopsy, Urine Sampling Liquid Biopsy and Saliva and Other Tissue Fluids Sampling Liquid Biopsy), Products and Service (Assays Kits, Instruments and Services), Circulating Biomarker (Circulating Tumour Cells, Circulating Tumour DNA (CTDNA), Cell-Free DNA, Extracellular Vesicles (EVS) and Other Circulating Biomarkers), Clinical Application (Early Cancer Screening, Therapy Selection, Treatment Monitoring and Recurrence Monitoring), Application (Cancer Applications and Non-Cancer Applications), End User (Reference Laboratories, Hospitals and Physician Laboratories, Academic and Research Centres and Other End Users) https://www.databridgemarketresearch.com/reports/global-liquid-biopsy-ma...
    Breast Cancer Liquid Biopsy Market , By Product (Consumables, Kits), Circulating Biomarkers (Extracellular Vesicles (EVs), Cell-free DNA (cfDNA), ctRNA, Circulating Tumor Cells (CTCs), cfRNA, Others), End Users (Laboratories, Hospitals, Physician Laboratories, Reference Laboratories, Public Health Laboratories, Research Institutes, Small Molecular Laboratories, Pathology Laboratories), Country https://www.databridgemarketresearch.com/reports/global-breast-cancer-li...
    Core Needle Biopsy Market , By Type (Full-Automated Core Needle Biopsy Device and Semi-Automated Core Needle Biopsy Device), Applications (Hospitals, Clinics and Others), Disease (Lung Cancer, Liver Cancer, Breast Cancer and Prostate Cancer), Range (14G- 18G, 18G), Distribution Channel (Direct Sales and Distributor), Country https://www.databridgemarketresearch.com/reports/global-core-needle-biop...
    Image-Guided Biopsy Market , By Technology (X- Ray, Ultrasound, Mammograpy, CT, MRI), Process (Fine Needle, Core Needle, Vacuum- Assisted Biopsy), End-User (Hospitals, Ambulatory Surgery Centers, Clinics, Research and Academic Institutes), Country https://www.databridgemarketresearch.com/reports/global-image-guided-bio...
    Vacuum-Assisted Biopsy Market By Guiding Technique (Stereotactic Vacuum Assist Biopsy System and Image Guided Vacuum Assist Biopsy System), Type (9-12G, 12G), Applications (Hospitals, Academic and Research Institutes and Diagnostics and Imaging Centres), Country https://www.databridgemarketresearch.com/reports/global-vacuum-assisted-...
    Needle Biopsy Market , By Needle Type (Trephine Biopsy Needles, Klima Sternal Needle, Salah Needle Aspiration Needle, Jamshidi Needle and Others), Ergonomics (Sharp, Blunt, Quincke, Chiba, Franseen and Others), Procedure (Fine-Needle Aspiration Biopsy, Core Needle Biopsy, Vacuum-Assisted Biopsy, Image-Guided Biopsy), Sample Site (Muscles, Bones and Other Organs), Utility (Disposable and Reusable), Application (Tumour, Infection, Inflammation and Others), End User (Hospitals, Diagnostic Centres, Biopsy Labs, Ambulatory Surgical Centres, Academic and Research Organizations and Others), Distribution Channel (Direct Tender, Retail Sales), Country https://www.databridgemarketresearch.com/reports/global-needle-biopsy-ma...
    Biopsy Forceps Market , By Type (Rigid Biopsy Forceps, Flexible Biopsy Forceps), Product Type (Cupped Jaws Biopsy Forceps, Oval Ring Jaws Biopsy Forceps, Radial Jaw Biopsy Forceps, Others), Usability (Disposable Biopsy Forceps, Reusable Biopsy Forceps), Application (Laparoscopy, Hysterectomy, Hysteroscopy, Others), End User (Hospitals, Clinics, Ambulatory Surgery Centers, Others), Country https://www.databridgemarketresearch.com/reports/global-biopsy-forceps-m...
    Biopsy Guns and Needles Market , By Product Type (Disposable, Reusable), Technique (Ultrasound-Guided Biopsy, Stereotactic-Guided Biopsy, MRI-Guided Biopsy, Others), Application (Breast Biopsy, Lung Biopsy, Colorectal Biopsy, Prostate Biopsy, Others), End User (Hospitals, Academic and Research Institutes, Diagnostic and Imaging Centers, Others), Country https://www.databridgemarketresearch.com/reports/global-biopsy-guns-and-...

Mpox a Cause for Concern in Pregnant Persons

Retrieved on: 
Mercoledì, Marzo 1, 2023

Mpox was known to infect pregnant persons in Africa, producing a 75 percent perinatal fatality rate.

Key Points: 
  • Mpox was known to infect pregnant persons in Africa, producing a 75 percent perinatal fatality rate.
  • They provide insight about how mpox can infect the fetus and describe details of a stillborn with placental infection, define and illustrate the Congenital Mpox Syndrome, and discuss mechanisms of intrauterine mpox transmission.
  • Although most mpox infections occurred in men, cases in women have increased, resulting in an intense concern for pregnant individuals acquiring the infection.
  • Healthcare providers should be aware that mpox occurring in pregnant persons is uncommon but has the capability to infect the fetus as well as the newborn and cause both perinatal morbidity and mortality.”

CytoVeris Publishes Preclinical Study Showing Potential of its TumorMAP System for Cancer Detection

Retrieved on: 
Martedì, Febbraio 7, 2023

FARMINGTON, Conn., Feb. 7, 2023 /PRNewswire-PRWeb/ -- CytoVeris Inc., a medical device company developing AI-powered cancer imaging technologies to enable more precise surgical decision-making and improve patient outcomes, today announced the publication of preclinical data showing the potential of its TumorMAPTM system to detect cancer. The system is based on a proprietary Multi-Spectral Tissue Auto-Fluorescence Imaging (MS-TAFI) technology that analyzes the "optical fingerprint" of tissue and deciphers its intrinsic biomolecular and morphological characteristics without the use of dyes or imaging agents. The study is published in the peer-reviewed journal Archives of Pathology and Laboratory Medicine. This technology has the potential to evaluate resection margins intraoperatively during surgical procedures.

Key Points: 
  • FARMINGTON, Conn., Feb. 7, 2023 /PRNewswire-PRWeb/ -- CytoVeris Inc. , a medical device company developing AI-powered cancer imaging technologies to enable more precise surgical decision-making and improve patient outcomes, today announced the publication of preclinical data showing the potential of its TumorMAPTM system to detect cancer.
  • The study is published in the peer-reviewed journal Archives of Pathology and Laboratory Medicine.
  • This technology has the potential to evaluate resection margins intraoperatively during surgical procedures.
  • "This study demonstrates the potential for our technology to improve the precision of breast cancer resection, but we won't stop there.

Paige Publishes Data Supporting First FDA-Authorized AI Software for Digital Pathology

Retrieved on: 
Mercoledì, Dicembre 21, 2022

The results were published in the Archives of Pathology & Laboratory Medicine and are available online here .

Key Points: 
  • The results were published in the Archives of Pathology & Laboratory Medicine and are available online here .
  • “These findings show Paige Prostate Detect is a robust AI software that can be used broadly in clinical practice to provide information physicians need to guide the accurate diagnosis of prostate cancer,” said David Klimstra, M.D., Founder and Chief Medical Officer at Paige.
  • “The study provides an important validation of our underlying technology and of the first-ever AI software for digital pathology to be authorized by the FDA,” said Thomas Fuchs, Dr.Sc., Founder and Chief Scientist at Paige.
  • Together with other studies on Paige’s technology, this study again demonstrates that Paige Prostate Detect is generalizable to multiple laboratories around the world.”

Florida Cancer Specialists & Research Institute Chief Medical Officer Shares Spotlight with Global Innovators in Genomic Health

Retrieved on: 
Mercoledì, Settembre 28, 2022

The event is bringing together global leaders in genomics and cancer care alongside policy, data and health equity experts who are redefining the standard of care through the positive impact of genomic health.

Key Points: 
  • The event is bringing together global leaders in genomics and cancer care alongside policy, data and health equity experts who are redefining the standard of care through the positive impact of genomic health.
  • Implement Global Oncology Insights Now, that will examine the infrastructural requirements to enable more clarity and faster diagnosis in the fight against cancer.
  • About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
    Recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida.
  • The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation.

Publication Describes New International Consortium Standardizing Immunohistochemistry

Retrieved on: 
Mercoledì, Settembre 21, 2022

Boston Cell Standards, a company standardizing tumor tissue testing with the first immunohistochemistry laboratory reference standards, announced the publication of a journal article summarizing the vital mission of the newly launched Consortium for Analytic Standardization in Immunohistochemistry (CASI).

Key Points: 
  • Boston Cell Standards, a company standardizing tumor tissue testing with the first immunohistochemistry laboratory reference standards, announced the publication of a journal article summarizing the vital mission of the newly launched Consortium for Analytic Standardization in Immunohistochemistry (CASI).
  • In the article, A Consortium for Analytic Standardization in Immunohistochemistry[i], published online in the Archives of Pathology & Laboratory Medicine, an international panel of pathologists and leaders of laboratory accreditation agencies describe the new consortium for establishing industrywide immunohistochemistry (IHC) reference standards to improve test accuracy and reproducibility.
  • Boston Cell Standards is the first and only company to develop and manufacture quantitative reference materials in the immunohistochemistry industry.
  • Arch Pathol Lab Med TBD, TBD (2022)
    [ii] Bogen S. A root cause analysis into the high error rate for clinical immunohistochemistry.

Groundbreaking CAP Guideline Clarifies Biomarker Testing, Impacts Multiple Cancer Types

Retrieved on: 
Mercoledì, Agosto 3, 2022

The CAP developed the guideline in collaboration with experts from the Association for Molecular Pathology (AMP), the American Society of Clinical Oncology (ASCO), and the patient advocacy group Fight Colorectal Cancer (Fight CRC).

Key Points: 
  • The CAP developed the guideline in collaboration with experts from the Association for Molecular Pathology (AMP), the American Society of Clinical Oncology (ASCO), and the patient advocacy group Fight Colorectal Cancer (Fight CRC).
  • The new CAP guideline helps to fill that gap, providing oncologists, pathologists, and laboratories of all sizes with objective, evidence-based recommendations to efficiently deploy specific assays and accurately identify patients eligible for treatment.
  • To ensure patients receive more effective testing with consistent, high-quality results, and expert interpretations, the CAP provides free, open access tools and resources with each evidence-based guideline to help clinical and laboratory teams adopt the recommendations.
  • For more information, READ THE CAP ANNUAL REPORT at CAP.ORG.