Biopsy

U.S. FDA Approves FoundationOne®CDx as a Companion Diagnostic for EGFR Therapeutics Targeting Exon 19 Deletions or Exon 21 Substitutions in Non-Small Cell Lung Cancer

Retrieved on: 
Thursday, March 17, 2022
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Deletions in exon 19 and substitutions in exon 21 account for roughly 85 percent of observed EGFR mutations in NSCLC.1 As a companion diagnostic for therapies targeting these mutations in NSCLC, FoundationOneCDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.

Key Points: 
  • Deletions in exon 19 and substitutions in exon 21 account for roughly 85 percent of observed EGFR mutations in NSCLC.1 As a companion diagnostic for therapies targeting these mutations in NSCLC, FoundationOneCDx offers oncologists flexibility when selecting the right therapy for their patients and ensures all FDA approved treatment options are considered within this group of therapies.
  • In addition to driving efficiency in clinical care, this approval is part of an innovative, efficient regulatory approach that simplifies the companion diagnostic approval process for Foundation Medicines biopharma partners developing EGFR inhibitor therapeutics targeting EGFR exon 19 deletions or exon 21 alterations in NSCLC while maintaining rigorous quality standards.
  • For a full list of targeted therapies for which FoundationOne CDx is indicated as a companion diagnostic, please visit http://www.foundationmedicine.com/genomic-testing/foundation-one-cdx .
  • Foundation Medicine and FoundationOne are registered trademarks of Foundation Medicine, Inc.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220317005345/en/

Global Digital Pathology Systems Market to Reach $1.2 Billion by 2026

Retrieved on: 
Wednesday, March 16, 2022
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SAN FRANCISCO, March 16, 2022 /PRNewswire/ -- A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Digital Pathology Systems - Global Market Trajectory & Analytics" .

Key Points: 
  • SAN FRANCISCO, March 16, 2022 /PRNewswire/ -- A new market study published by Global Industry Analysts Inc., (GIA) the premier market research company, today released its report titled "Digital Pathology Systems - Global Market Trajectory & Analytics" .
  • Amid the COVID-19 crisis, the global market for Digital Pathology Systems estimated at US$810.9 Million in the year 2022, is projected to reach a revised size of US$1.2 Billion by 2026, growing at a CAGR of 13.9% over the analysis period.
  • This segment currently accounts for a 29.2% share of the global Digital Pathology Systems market.
  • The growing need for real time access to pathology outcomes constitutes a major driving force for the digital pathology market.

Proscia and Siemens Healthineers Ink Agreement to Expand Global Reach of Digital Pathology

Retrieved on: 
Wednesday, March 16, 2022
General Health, Health, Data Management, Technology, Software, Carbon, Biopsy, Solution, OEM, Siemens, Partnership, DX, Analyze (imaging software), AI, Enterprise imaging, Marie Cassidy, Laboratory, Data management, Adoption, Diagnosis, Graphics, Siemens Healthineers, Research, Cancer, CEO, Population, Industry, Efficiency, Software, Ecosystem, Pathology, Medical imaging

Proscia , the leader in digital and computational pathology solutions, today announced a multi-year OEM agreement with Siemens Healthineers.

Key Points: 
  • Proscia , the leader in digital and computational pathology solutions, today announced a multi-year OEM agreement with Siemens Healthineers.
  • Under the agreement, Siemens Healthineers will expand its Enterprise Imaging offering towards the global digital pathology market using Proscias Concentriq Dx platform.
  • With Proscias Concentriq Dx platform, Siemens Healthineers is entering the digital pathology market to satiate the rampant demand and expand its Enterprise Imaging offering with industry-leading technology to realize the full value of digital pathology operations.
  • Our partnership with Siemens Healthineers represents a seminal moment for Proscia and a monumental leap for digital pathology on a global scale, said David West, CEO of Proscia.

Altimmune Reports Fourth Quarter and Full Year 2021 Financial Results and Provides a Corporate Update

Retrieved on: 
Tuesday, March 15, 2022
Fatty liver disease, Biopsy, Research, NASH, Acquisition, GLOBE, Principal investigator, Home After Three Months Away, Liver disease, Human, Investment, Obesity, Cardiovascular disease, Government, Toxicology, Weight loss, Insulin resistance, NAFLD, Diabetes, Overweight, Blood, Maintenance, Pharmaceutical industry, Dietary supplement, Vaccine, Cryptocurrency

GAITHERSBURG, Md., March 15, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.

Key Points: 
  • Strong cash position of $190.3 million as of December 31, 2021
    GAITHERSBURG, Md., March 15, 2022 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced financial results for the fourth quarter and full year ended December 31, 2021 and provided a corporate update.
  • We expect the next 12 months to be a period of intense execution with value-creating data readouts from multiple clinical trials.
  • In addition, we expect to read out our HepTcell trial in the first half of 2023.
  • Financial Results for the Three Months Ended December 31, 2021
    Altimmune had cash, cash equivalents, short-term investments and restricted cash totaling $190.3 million at December 31, 2021.

Independent Data Presented at Society for Surgical Oncology Conference Demonstrated DecisionDx®-Melanoma Outperforms T-Stage at Identifying Patients with Low Risk of Sentinel Lymph Node Positivity

Retrieved on: 
Friday, March 11, 2022
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The data will be shared in a poster presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care, being held in Dallas and virtually, March 9-12, 2022.

Key Points: 
  • The data will be shared in a poster presentation at the Society of Surgical Oncology (SSO) 2022 International Conference on Surgical Cancer Care, being held in Dallas and virtually, March 9-12, 2022.
  • While the sentinel lymph node biopsy (SLNB) surgical procedure is a common technique in determining possible tumor metastasis, our current criteria for biopsy may be overestimating a persons risk of having a positive node.
  • Using T-stage alone, only two patients (T1a with no other high-risk tumor features) were accurately identified as low risk (
  • To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result.

DermTech Study, “Cost-Benefit Analysis of the Pigmented Lesion Assay When Introduced into the Visual Assessment / Histopathology Pathway for Lesions Clinically Suspicious for Melanoma,” Published in SKIN: The Journal of Cutaneous Medicine

Retrieved on: 
Tuesday, March 8, 2022
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It is used to identify high-risk lesions and help providers determine the next best treatment: either a biopsy and histopathologic evaluation or clinical surveillance of the lesion in question.

Key Points: 
  • It is used to identify high-risk lesions and help providers determine the next best treatment: either a biopsy and histopathologic evaluation or clinical surveillance of the lesion in question.
  • Comparatively, the traditional care pathway for evaluating suspicious moles is visual assessment, which is subjective, followed by a potentially avoidable surgical biopsy and histopathologic assessment.
  • This model predicted annual net savings of $0.54 PMPM for commercial health plans over a three-year period with incorporation of the PLA.
  • There is a clear need for objective, cost-effective technologies to help improve the assessment, classification and management of skin lesions and moles suspicious for melanoma, said Dr. Siegel.

New Robotic Assisted Transperineal Needle-Guidance System for Prostate Biopsy and Cancer Ablations Received U.S FDA 510(k) Clearance

Retrieved on: 
Saturday, March 5, 2022
Edgar J. Kaufmann, Prostate cancer, Biopsy, Infection, U.S. FDA, Vipul Patel, Patient, Urology, BJU, Kadokawa Future Publishing, Mona, Löwe, BJU International, S, Solution, Dr. R. Ahmed Dental College and Hospital, Systematic review, Donaldson, CEO, Comparison, Technology, MRI, P, Mona Lisa, Nave, Medical imaging

The new robotic assisted transperineal needle-guidance system allows urologists to plan and position a single needle or multiple needles during image-guided diagnostic and interventional prostate procedures.

Key Points: 
  • The new robotic assisted transperineal needle-guidance system allows urologists to plan and position a single needle or multiple needles during image-guided diagnostic and interventional prostate procedures.
  • The Mona Lisa system simplifies needle positioning by providing robotic assisted guidance for the insertion."
  • The iSR'obot Mona Lisa 2.0 automatically supports needle positioning during transperineal prostate biopsy and prostate cancer ablation based on a customized needle plan.
  • Comparison of clinically significant prostate cancer detection by MRI cognitive biopsy and in-bore MRI-targeted biopsy for nave biopsy patients.

ClearPoint Neuro Reports Fourth Quarter and Full-Year 2021 Results

Retrieved on: 
Tuesday, March 1, 2022
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SOLANA BEACH, Calif., March 01, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its fourth quarter and full-year ended December 31, 2021.

Key Points: 
  • SOLANA BEACH, Calif., March 01, 2022 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a global therapy-enabling platform company providing navigation and delivery to the brain, today announced financial results for its fourth quarter and full-year ended December 31, 2021.
  • Reported fourth quarter 2021 revenue of $4.3 million, an increase of 15% compared with the fourth quarter of 2020.
  • Functional neurosurgery navigation revenue increased 37% to $2.1 million for the fourth quarter of 2021 from $1.6 million for the same period in 2020.
  • Operating expenses for the fourth quarter of 2021 were $7.3 million, compared to $4.5 million for the fourth quarter of 2020.

Goldfinch Bio Announces Positive Preliminary Data from Phase 2 Clinical Trial Evaluating GFB-887 as a Precision Medicine for Patients with Focal Segmental Glomerular Sclerosis (FSGS)

Retrieved on: 
Monday, February 28, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, TRPC5, Diabetic nephropathy, Sequence, DN, HIV disease progression rates, FSGS, Pharmacokinetics, Providence Healthcare, Diagnosis, Association, Gene, University, Research, Glomerular filtration rate, Kidney, FACP, Safety, Mutation, Transience, Bio, Hope, FASN, Precision medicine, Șaeș, Proteinuria, Dialysis, Patient, Quality of life, Biopsy, University of Washington Medical Center, Podocyte, Kidney failure, Kidney disease, EGFR, Pharmaceutical industry, Medical imaging, UPCR, Medicine

No treatment effect was observed in the initial cohort of 44 treated DN patients.

Key Points: 
  • No treatment effect was observed in the initial cohort of 44 treated DN patients.
  • I am excited to watch the continued progress of GFB-887 and the potential impact on the kidney health of FSGS patients.
  • Anthony Johnson, M.D., President and Chief Executive Officer of Goldfinch Bio, commented, We are pleased with the initial findings of clinical activity in our Phase 2 trial of GFB-887.
  • 1 Patients diagnosed with treatment resistant minimal change disease, which is considered a subset of FSGS, will also be allowed into the Phase 2 clinical.

NeoDynamics has filed for registration of NeoNavia® in the US

Retrieved on: 
Tuesday, March 1, 2022
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STOCKHOLM, March 1, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has filed a registration application for its innovative pulse biopsy system NeoNavia with the US Food and Drug Administration, FDA.

Key Points: 
  • STOCKHOLM, March 1, 2022 /PRNewswire/ -- The MedTech company NeoDynamics has filed a registration application for its innovative pulse biopsy system NeoNavia with the US Food and Drug Administration, FDA.
  • "By filing for registration of NeoNavia in the US, NeoDynamics reaches an important milestone.
  • The US is a huge potential market for NeoNavia and a US registration is also an important seal of quality for future collaborations", says CEO Anna Eriksrud.
  • "We expect that it will take a number of months to get the registration application approved."