IVDR

Grifols Procleix ArboPlex Assay® Receives CE Mark, the First and Only 4-in-1 NAT for Arbovirus Screening

Retrieved on: 
Thursday, April 4, 2024
Certification, Plasma, CE, GRFS, Risk, Arbovirus, Climate, RNA, GRF, Fever Dream, IVDR, Chikungunya, Death, Dengue virus, MCE, Blood bank, NAT, Vertically transmitted infection, Medical device

These are the four most significant arboviruses of concern, all spread through mosquito vectors.

Key Points: 
  • These are the four most significant arboviruses of concern, all spread through mosquito vectors.
  • With the dengue virus alone, there were more than 5 million cases and 5,000 deaths reported globally in 2023.1
    Further strengthening the Grifols Procleix portfolio for blood donor screening, the Procleix ArboPlex Assay uses plasma or serum samples to detect arboviral RNA.
  • Blood banks and collection centers could decide that deferrals are unnecessary if donors were tested and found negative using the Procleix ArboPlex Assay.
  • “With its 4-in-1 arbovirus test feature, the Grifols Procleix ArboPlex Assay has the ability to speed up and overall improve donor screening laboratory efficiency,” said Antonio Martínez, president of Grifols Diagnostic Business Unit.

Overcoming EU IVDR Challenges When Using Clinical Trial Assays to Accelerate Global CDx Trials, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Wednesday, March 27, 2024
CDX, EUDAMED, IVD, Medical device, Regulatory affairs, CPS, European, IVDR

TORONTO, March 27, 2024 /PRNewswire-PRWeb/ -- From May 2022 onwards, clinical trial assays being developed as companion diagnostics (CDx) need to meet the requirements of the European Union In Vitro Diagnostics Regulation (EU IVDR; Regulation (EU) 2017/746 (EU IVDR)), which includes more stringent oversight during the clinical performance study (CPS) phase of development.

Key Points: 
  • Attendees will gain insights into solutions to help overcome some IVDR hurdles for global clinical trials.
  • The featured speakers will share key considerations when planning for CDx trials with EU sites.
  • Register for this webinar today where experts will share their experience with the EU IVDR and provide insights into solving challenges faced during the EU IVDR submission process.
  • For more information, or to register for this event, visit Overcoming EU IVDR Challenges When Using Clinical Trial Assays to Accelerate Global CDx Trials.

BIO-TECHNE RECEIVES EUROPEAN IVDR CERTIFICATION FOR DIAGNOSTIC TEST TO MONITOR CHRONIC MYELOID LEUKEMIA

Retrieved on: 
Friday, March 22, 2024
Certification, Acute leukemia, Kit, BCR-ABL, Patient, CML, Class, Bio-Techne, Sale, Cancer, IVDR, Diagnosis, Workflow, ABL1, Safety, Liquid biopsy, TKI, Physician, IVDD, Medical device

MINNEAPOLIS, March 22, 2024 /PRNewswire/ -- Bio-Techne Corporation (NASDAQ: TECH) today announced that Asuragen, part of Bio-Techne's Molecular Diagnostics Division, has completed the Class C Certification under the new European Union In Vitro Diagnostic Regulation (IVDR) for its QuantideX® qPCR BCR-ABL IS Kit. Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.

Key Points: 
  • Previously, the kit was CE-IVD marked for sale in the EU in compliance with the In Vitro Diagnostic Directive (IVDD), which has now been replaced by the IVDR.
  • The QuantideX qPCR BCR-ABL IS Kit gives labs a robust and reliable tool for monitoring chronic myeloid leukemia (CML) patients.
  • The highly sensitive qPCR-based in vitro diagnostic test quantifies BCR-ABL1 and ABL1 transcripts in blood samples from patients with CML to determine their response to tyrosine kinase inhibitor (TKI) therapy.
  • CML patients must undergo regular monitoring to ensure that they continue to receive the most appropriate treatment for their cancer.

IVD Survival Guide: Navigating Uncertainty in the US and European IVD Regulatory Landscape, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Monday, March 18, 2024
Research, IVD, Medtech, 2005 in television, Regulatory affairs, FDA, IVDR, Medical device

TORONTO, March 18, 2024 /PRNewswire-PRWeb/ -- In vitro diagnostic (IVD) testing has become a cornerstone of modern medicine, with an estimated 70 percent of medical decisions made based on laboratory test results. Given the vital role IVDs play in guiding care, regulatory agencies frequently review approval requirements, and the regulatory frameworks governing these devices are constantly evolving.

Key Points: 
  • In this free webinar, gain insights into how regulatory guidance can help in vitro diagnostic (IVD) developers proactively navigate uncertainty and mitigate potential financial, compliance and operational risks.
  • Attendees will learn about the FDA's proposed rule to regulate laboratory-developed tests (LDTs) as IVDs and the FDA's reclassification for high-risk IVDs.
  • The featured speakers will discuss key changes introduced by the EU In Vitro Diagnostics Regulation (IVDR).
  • Register for this webinar today to gain insights into how regulatory guidance can help IVD developers proactively navigate uncertainty and mitigate potential financial, compliance and operational risks.

Twist Bioscience Launches IVDR-compliant Precision Dx Products for Whole Exome Sequencing

Retrieved on: 
Tuesday, March 5, 2024
Research, Other Health, Pharmaceutical, Technology, Medical Devices, Genetics, Health Technology, Science, Nanotechnology, Biotechnology, Medical Supplies, Health, Other Science, Twist Bioscience, Twist, Reagent, Silicon, IVDR, NGS, Documentation, Doctor of Philosophy, Safety, Certification, Exon, Genome, Laboratory, DNA, IVD, Workflow, Medical device

The suite of our CE-marked Products includes:

Key Points: 
  • The suite of our CE-marked Products includes:
    The Twist Precision Prep and Enrichment Dx Kit1 (Reagents for enzymatic fragmentation, library preparation, and target enrichment), which is panel-agnostic2
    Twist Precision Exome Dx Kit1 (Reagents for enzymatic fragmentation, library preparation, and target enrichment along with targeted capture probes for exome enrichment; IVDR compliant workflow)
    The Twist Precision Prep and Enrichment Dx Kit and the Twist Precision Exome Dx Panel can be used individually within existing workflows or as a combined solution known as the Twist Precision Exome Dx Kit.
  • “The Twist Precision Dx products are our first NGS product line specifically developed to be included within regulated customer products.
  • The Twist Precision Exome Dx Panel1 is a qualified Twist DNA panel that can be used in conjunction with the Twist Precision Prep and Enrichment Dx kit to produce exome-enriched libraries compatible for NGS applications.
  • Twist Precision Exome Dx Kit1 utilizes the qualified Twist Precision Exome Dx Panel along with the Twist Precision Prep and Enrichment Dx Kit to produce exome-enriched libraries compatible for NGS applications.

Impact of the In-Vitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024 Report - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 5, 2024
Pharmaceutical, Health, Clinical Trials, Other Health, IVDR, Conduct, 2005 in television, Gross metropolitan product, European Economic Area, European, Safety, ChromeOS, Patient, PSA, Clinical trial, Patient safety, IVD, Medical device

The "Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Impact of the InVitro Diagnostic Regulation (IVDR) on the Conduct of Clinical Trials in the EU and CRO Outsourcing - 2024" report has been added to ResearchAndMarkets.com's offering.
  • In Vitro Diagnostic (IVD) tests are critical to clinical trial operations, serving to help select patients in clinical trials, provide accurate efficacy results, monitor patient response, and more.
  • As a result, current and pending drug clinical trials utilizing IVD tests now must also adhere to the IVDR.
  • However, this process is currently complex and uncoordinated, resulting in delays in clinical trials and patients waiting longer to participate in clinical trials, or even not participating at all.

Corista DP3® Platform Receives Class II Medical Device License From Health Canada

Retrieved on: 
Wednesday, February 7, 2024
Partnership, Class, European, Marie Cassidy, Diagnosis, Pathology, Friends, European Economic Area, AGFA, CE marking, Health Canada, IVDR, Health

CONCORD, Mass., Feb. 7, 2024 /PRNewswire-PRWeb/ -- Corista, a leader in digital pathology solutions, is excited to announce that it has received a Class II Medical Device License from Health Canada for its DP3 platform.

Key Points: 
  • CONCORD, Mass., Feb. 7, 2024 /PRNewswire-PRWeb/ -- Corista, a leader in digital pathology solutions, is excited to announce that it has received a Class II Medical Device License from Health Canada for its DP3 platform.
  • Attaining the Class II Medical Device License from Canada is an important milestone in making this possible," says Corista CEO and Co-Founder Elizabeth Wingard.
  • The Class II Medical Device License further supports Corista's recently announced strategic partnership with AGFA HealthCare, providing a digital pathology workflow solution to its Canadian customer base.
  • "Attaining the Class II Medical Device License from Canada is an important milestone in making this possible.

BD, Techcyte Announce Strategic Collaboration to Offer AI-Based Digital Cervical Cytology System for Pap Testing

Retrieved on: 
Tuesday, January 30, 2024
LBC, Mortality, Artificial intelligence, Woman, Marie Cassidy, Patient, IVD, U.S. FDA, Fatigue, AI, Cancer, BDX, Human papillomavirus infection, Cell, Cervical cancer, Pap test, FDA, Distraction, HPV, IVDR, CE, Certification, Medical device

FRANKLIN LAKES, N.J. and OREM, Utah, Jan. 30, 2024 /PRNewswire/ -- BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Techcyte, a world leader in artificial intelligence (AI)-based digital diagnostics, today announced a strategic collaboration agreement to offer an AI-based algorithm that guides cytologists and pathologists to efficiently and effectively identify evidence of cervical cancer and precancer using whole-slide imaging.

Key Points: 
  • With the digital cervical cytology system, the samples can be scanned, converted to a digital slide image, and then reviewed on a computer monitor in a lab or from a remote location.
  • In addition, the digital cervical cytology system uses an AI-based algorithm to prioritize and present clinically relevant cells for visual evaluation.
  • "Eye strain, fatigue, distractions, and intense workloads can make manually reading Pap smears difficult," said Ben Cahoon, CEO of Techcyte.
  • "Our digital workflow supported by an AI-based algorithm can assist lab professionals in delivering consistent results for their patients.

Dxcover To Present at BIOTECH SHOWCASE™ 2024

Retrieved on: 
Wednesday, December 20, 2023
Research, Biotechnology, Other Health, Health, Pharmaceutical, General Health, Other Science, Science, Oncology, IVDR, Quality of life, ESMO, Partnership, Colorectal cancer, Doctor of Philosophy, Congress, Cancer, Brain, Poster, Machine learning, Therapy, Algorithm

Dxcover Limited , a clinical-stage diagnostics company pioneering Multi-Omic Spectral Analysis for early detection of multiple cancers, today announced that Founder and newly announced CEO Matthew Baker, PhD, will be presenting at Biotech Showcase 2024.

Key Points: 
  • Dxcover Limited , a clinical-stage diagnostics company pioneering Multi-Omic Spectral Analysis for early detection of multiple cancers, today announced that Founder and newly announced CEO Matthew Baker, PhD, will be presenting at Biotech Showcase 2024.
  • Dxcover’s novel platform utilizes infrared spectroscopy and AI algorithms to provide Multi-Omic Spectral Analysis (MOSA) of blood serum.
  • “Dxcover was founded to enable the earliest detection of cancer and we are thrilled to present at Biotech Showcase and share our science with potential collaborators, partners and investors,” said Prof. Baker.
  • “We are delighted that Dxcover will be joining us in San Francisco and presenting at Biotech Showcase this year,” said Sara Demy, CEO of Demy-Colton.

Dxcover Announces Updates to Executive Leadership Team

Retrieved on: 
Tuesday, December 12, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Health Technology, Clinical Trials, Lung, University of Central Lancashire, School, Breast, IP, Colorectal cancer, ESMO, Patient, British Journal of Cancer, Data analysis, Algorithm, University of Strathclyde, Kidney, Prostate cancer, Machine learning, Business, Medical school, University, Central Lancashire, Cancer, Survival, Growth, Congress, Quality of life, Poster, IVDR, Innovation system, Brain, Management, Chemistry

Dxcover Limited , a clinical-stage diagnostics company pioneering Multi-Omic Spectral Analysis for early detection of multiple cancers, today announced updates to its executive management team.

Key Points: 
  • Dxcover Limited , a clinical-stage diagnostics company pioneering Multi-Omic Spectral Analysis for early detection of multiple cancers, today announced updates to its executive management team.
  • Dxcover’s Co-Founder Prof. Matthew Baker will transition from his role as Chief Technical Officer to Chief Executive Officer.
  • Another Co-Founder Dr David Palmer, who has been Chief Data Scientist since spin-out, has been named Chief Technical Officer.
  • “I want to express my deepest gratitude to Mark for his dedicated and unwavering leadership in the first phase of Dxcover’s story.