Screening

BrainStorm Cell Therapeutics Announces Agreement with FDA on a Special Protocol Assessment (SPA) for Phase 3b Trial in ALS

Retrieved on: 
Tuesday, April 9, 2024
Neurology, Neuroprotection, Element, Conference call, Institutional review board, Cerebrospinal fluid, Survival, Disease, ALS, SPA, Bone marrow, CSF, Data monitoring committee, Webcast, Patient, Protocol, Biomarker, Mortality, Microsoft Exchange Server, Stem cell, DMC, Screening, Agency, Safety, CAFS, Brainstorm, Therapy, Marketing, FDA, BLA, Neuroinflammation, Food, Pharmaceutical industry

NEW YORK, April 9, 2024 /PRNewswire/ -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS). 

Key Points: 
  • (NASDAQ: BCLI), a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced that it received written agreement from the U.S. Food and Drug Administration (FDA), under a Special Protocol Assessment (SPA), on the design for a Phase 3b trial of NurOwn® in amyotrophic lateral sclerosis (ALS).
  • The SPA agreement with the FDA validates the clinical trial protocol and statistical analysis of the planned Phase 3b trial of NurOwn, demonstrating their adequacy for addressing objectives that support a future BLA (Biologics License Application) in ALS.
  • We appreciate the Agency's engagement and guidance during the SPA process and look forward to moving forward with the study."
  • The Phase 3b trial (Study BCT-006-US) will be a two-part, multicenter, study designed to assess the efficacy and safety of NurOwn in patients with ALS.

ZERO Prostate Cancer Promotes Early Detection as a National Priority During Prostate Cancer Awareness Month

Retrieved on: 
Tuesday, August 29, 2023
Risk, National Prostate Health Month, Prostate cancer, Education, Cancer, ZERO, Screening, American Cancer Society, Disease, Dairy

WASHINGTON, Aug. 29, 2023 /PRNewswire/ -- ZERO Prostate Cancer urges men to learn about their prostate cancer risks and early detection during Prostate Cancer Awareness Month, beginning September 1. According to the American Cancer Society, 3.1 million+ men live with prostate cancer, making it the most commonly diagnosed cancer and one of the leading causes of cancer deaths among American men.

Key Points: 
  • WASHINGTON, Aug. 29, 2023 /PRNewswire/ -- ZERO Prostate Cancer urges men to learn about their prostate cancer risks and early detection during Prostate Cancer Awareness Month , beginning September 1.
  • According to the American Cancer Society , 3.1 million+ men live with prostate cancer, making it the most commonly diagnosed cancer and one of the leading causes of cancer deaths among American men.
  • "Prostate Cancer Awareness Month elevates the urgency of early detection.
  • ZERO Prostate Cancer Day will be held on September 28, encouraging donations and sharing of life-saving messages.

Human Services Department announces screening tool to help prevent substance use disorder

Retrieved on: 
Tuesday, March 7, 2023
Substance use disorder, Organization, Education, Health care, SUD, Connections, HSD, CHESS, Patient, Health, Screening, brief intervention and referral to treatment, Feedback, SBIRT, Nursing, Screening

SANTA FE, New Mexico, March 07, 2023 (GLOBE NEWSWIRE) -- The New Mexico Human Services Department (HSD) announced today that it partnered with CHESS Health to launch ePrevention, a screening tool that can help identify high-risk substance use and prompt healthcare providers and community organizations to respond to and refer at-risk individuals to supports and services to prevent the development of substance use disorder (SUD).

Key Points: 
  • SANTA FE, New Mexico, March 07, 2023 (GLOBE NEWSWIRE) -- The New Mexico Human Services Department (HSD) announced today that it partnered with CHESS Health to launch ePrevention, a screening tool that can help identify high-risk substance use and prompt healthcare providers and community organizations to respond to and refer at-risk individuals to supports and services to prevent the development of substance use disorder (SUD).
  • HSD offers ePrevention to healthcare providers so they can conduct online screening for high-risk substance use for their patients.
  • Screenings can be conducted anonymously, and individuals are offered a series of personalized interventions designed to help reduce substance use.
  • “The ePrevention screening tool enables us to support New Mexico’s communities in proactively combating the crisis of substance use disorder — so we can detect problematic substance use before it develops into a disorder,” said Neal Bowen, Ph.D., HSD’s Director of Behavioral Health Services.

Cytokinetics Announces Data From Its ALS Program Presented at the 32nd International Symposium on ALS/MND

Retrieved on: 
Friday, December 10, 2021
Fellow, Patient, HIV disease progression rates, Amyotrophic lateral sclerosis, SAN, Health status of White Americans, Population, International Symposium on Graph Drawing, Investigational New Drug, Research and development, Spear, Senior, Development, Screening, Quality of life, ALS Functional Rating Scale - Revised, Clinical research, User experience, IMPACT, GLOBE, Pharmaceutical industry

Stacy Rudnicki, M.D., Vice President, Clinical Research, Cytokinetics, presented an analysis of the baseline characteristics of the first 27 patients enrolled in COURAGE-ALS.

Key Points: 
  • Stacy Rudnicki, M.D., Vice President, Clinical Research, Cytokinetics, presented an analysis of the baseline characteristics of the first 27 patients enrolled in COURAGE-ALS.
  • COURAGE-ALS is a Phase 3, multi-center, double-blind, randomized, placebo-controlled trial of reldesemtiv expected to enroll approximately 555 patients with ALS.
  • Key inclusion criteria in COURAGE-ALS include symptom onset within 24 months and ALS Functional Rating Scale-Revised (ALSFRS-R) total score of 44.
  • For further information regarding these and other risks related to Cytokinetics business, investors should consult Cytokinetics filings with the Securities and Exchange Commission.

REGENXBIO Presents Additional Positive Interim Data from Trials of RGX-314 in Wet AMD and Diabetic Retinopathy Using Suprachoroidal Delivery at AAO 2021

Retrieved on: 
Friday, November 12, 2021
Society, American Academy of Ophthalmology, Șaeș, Ranibizumab, Consultant, Episcleritis, Securities Exchange Act of 1934, Growth, GC, COVID-19, Diabetic retinopathy, Screening, ASRS, DME, VEGF, Drug Quality and Security Act, Visual acuity, Safety, Financial condition report, DR, Technology, Research, Securities Act of 1933, Injection, Intention, Severe cognitive impairment, PDR, Patient, AAV, CRT, U.S. Securities and Exchange Commission, Conjunctivitis, Eye, Inflammation, Program, Risk, American Academy, SEC, Analysis, Result, Conversation, Retina, Macular degeneration, Neutralizing antibody, AAO, Annual report, AMD, NAV, Perception, Incidence, Death, Pharmaceutical industry, Vaccine, Medical device

AAVIATE is a multi-center, open-label, randomized, active-controlled, dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector.

Key Points: 
  • AAVIATE is a multi-center, open-label, randomized, active-controlled, dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector.
  • Cohort 3 is evaluating RGX-314 at the same dose level as Cohort 2 in 20 patients who are neutralizing antibody (NAb) positive.
  • Enrollment is ongoing in two additional cohorts (Cohorts 4 and 5) to evaluate RGX-314 at a third dose level of 1x1012 GC/eye.
  • RGX-314 is being investigated as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions.

REGENXBIO Presents Positive Initial Data from Phase II AAVIATE® Trial of RGX-314 for the Treatment of Wet AMD Using Suprachoroidal Delivery and Provides Trial Update at Retina Society 54th Annual Scientific Meeting

Retrieved on: 
Friday, October 1, 2021
Securities Act of 1933, Perception, Cohort, AMD, Macular degeneration, Johns Hopkins Hospital, Death, Growth, GC, Neutralizing antibody, Injection, Safety, AAV, SEC, Technology, Screening, Drug Quality and Security Act, U.S. Securities and Exchange Commission, Webcast, Retina, Phase, Analysis, Diabetic retinopathy, Consultant, Result, Clinical trial, Patient, Risk, Annual report, Conversation, CRT, Health, Eye, Șaeș, Intention, Ranibizumab, Financial condition report, Johns Hopkins School of Medicine, Visual acuity, Severe cognitive impairment, QF 4.7-inch Mk I – IV naval gun, VEGF, COVID-19, NAV, Securities Exchange Act of 1934, Pharmaceutical industry, Medical device, Vaccine

REGENXBIO Inc. (Nasdaq: RGNX) today announced initial data from the ongoing Phase II AAVIATE trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.

Key Points: 
  • REGENXBIO Inc. (Nasdaq: RGNX) today announced initial data from the ongoing Phase II AAVIATE trial of RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using in-office suprachoroidal delivery.
  • "These are the first data ever reported from a gene therapy delivered to the suprachoroidal space of the eye in a clinical trial," said Dr. London.
  • AAVIATE is a multi-center, open-label, randomized, active-controlled, dose-escalation trial that will evaluate the efficacy, safety and tolerability of suprachoroidal delivery of RGX-314 using the SCS Microinjector.
  • SCS Microinjector is a trademark of Clearside Biomedical, Inc. All other trademarks referenced herein are registered trademarks of REGENXBIO.

Median Technologies Announces Outstanding Performance for its iBiopsy® Lung Cancer Screening CADx1 to Accurately Characterize Malignant vs Benign Lung Nodules Based on a Large-scale Patient Cohort

Retrieved on: 
Monday, September 6, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Medicine, Lung cancer, Medical tests, Clinical medicine, Health, Radiology, Lung nodule, Screening, Cancer screening, Cancer, CT scan, Oncology

Median Technologies (Paris:ALMDT) (ALMDT:PA) announces outstanding performance based on a large-scale lung cancer screening (LCS) patient cohort to characterize malignant vs benign lung nodules based on a deep learning algorithm on low-dose chest computed tomography.

Key Points: 
  • Median Technologies (Paris:ALMDT) (ALMDT:PA) announces outstanding performance based on a large-scale lung cancer screening (LCS) patient cohort to characterize malignant vs benign lung nodules based on a deep learning algorithm on low-dose chest computed tomography.
  • The Median Technologies iBiopsy Lung Cancer Development Plan was launched in February 2021 , as part of the Companys strategic positioning in early-stage disease diagnosis.
  • Major international studies have shown that LDCT lung cancer screening can reduce mortality by 44% (NELSON Trial, 2018).
  • The study was based on a cohort of 1,696 patients from the National Lung Screening Trial cases (NLST) consisting of a total of 15,608 lung nodules.

Global Employment Screening Services Market (2021 to 2028) - by Service, Application and Geography - ResearchAndMarkets.com

Retrieved on: 
Wednesday, August 4, 2021
Professional Services, Human Resources, Criminal records, Articles, Background check, Law enforcement, Recruitment, Security, Screening, Tenant screening

The "Employment Screening Services Market by Service and Application: Global Opportunity Analysis and Industry Forecast, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Employment Screening Services Market by Service and Application: Global Opportunity Analysis and Industry Forecast, 2021-2028" report has been added to ResearchAndMarkets.com's offering.
  • Employment screening services include wide range of background verification checks, such as employment eligibility verifications, fingerprint screening, contractor screening, sex offender checks, motor vehicle checks, drug & alcohol screening, resident monitoring, and rental payment history.
  • The global employment screening services market is expected to be driven by improved quality of workforce, enhanced regulatory compliance with respect to employment, and merits associated with employment screening in organizations.
  • The employment screening services market is segmented on the basis of service, application, and region.

Genetron Health Partners with Guizhou Province’s Dafang County to Lead Liver Cancer Early Screening Project

Retrieved on: 
Thursday, July 29, 2021
Medicine, Health sciences, Medical terminology, Prevention, Health, Cancer screening, Oncology, Cancer prevention, Cancer, Screening, Liver cancer, Preventive healthcare

BEIJING, July 29, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (Genetron Health or the Company, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced that it will work with Guizhou Provinces Dafang County authorities to lead the Early Screening for Regional Liver Cancer Prevention and Containment Demonstration Project.

Key Points: 
  • BEIJING, July 29, 2021 (GLOBE NEWSWIRE) -- Genetron Holdings Limited (Genetron Health or the Company, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced that it will work with Guizhou Provinces Dafang County authorities to lead the Early Screening for Regional Liver Cancer Prevention and Containment Demonstration Project.
  • Genetron Health will work with its partners to carry out early screening, diagnosis, treatment, follow-up screenings, and patient management for high risk liver cancer groups in Guizhous Dafang County.
  • Genetron Health will establish a comprehensive cancer prevention and containment model that prioritizes prevention, and integrates it with long-term screening management, diagnosis, and treatment.
  • In 2019, Chinas National Cancer Center used HCCscreens liver cancer early screening liquid biopsy technology in a large-scale prospective cohort study.

Spectral Medical Inc. Provides Tigris Clinical Trial Update

Retrieved on: 
Wednesday, July 28, 2021
Rivers of Asia, Health sciences, Rivers, Geography of Iraqi Kurdistan, Levant, Mesopotamia, Tur Abdin, Upper Mesopotamia, Clinical trial, Screening, Euphrates, Tigris

Our sites have aggressively increased activities around the Tigris trial, including heightened patient screening, enrollment, and randomization.

Key Points: 
  • Our sites have aggressively increased activities around the Tigris trial, including heightened patient screening, enrollment, and randomization.
  • We are also onboarding additional clinical trial sites, including the University of Michigan, which is now actively screening patients.
  • Chris Seto, CEO of Spectral, further noted, With a total of nineteen patients now randomized within the Tigris trial, we are pleased with the acceleration of trial activities and remain optimistic about the trial outcome.
  • We remain highly encouraged by the outlook for the Tigris trial based on the outcome of the earlier EUPHRATES trial.