IVD

QIAGEN strengthens its portfolio for cancer research, showcasing latest product launches at AACR Annual Meeting 2024

Retrieved on: 
Wednesday, April 3, 2024
EGFR, Gene, Nested polymerase chain reaction, Professor, Cancer Institute, Circulating free DNA, Neoplasm, TCR, Research institute, QGEN, Research, PCR, Central business district, NGS, DNA, BRAF, Diagnosis, WIA, Cancer, Immune system, Liquid biopsy, UMI, Mutation, Genetics, Human genetics, Senior, AACR, Medical school, QIAGEN, Poster, Environment, IVD, Urine

Two Exhibitor Spotlight Theater sessions and several poster presentations will highlight additional advances from QIAGEN in this field.

Key Points: 
  • Two Exhibitor Spotlight Theater sessions and several poster presentations will highlight additional advances from QIAGEN in this field.
  • EGFR and BRAF are genes essential for normal cell growth and function, but mutations in these genes can result in cancer development.
  • To advance research on how the immune system interacts with cancer, QIAGEN has introduced the QIAseq Targeted RNA-seq Panel for T-cell receptors.
  • Learn more about QIAGEN’s offering at the AACR Annual Meeting 2024, (booth #922 in the San Diego Convention Center) and poster presentations highlighting new solutions in digital PCR, NGS and preanalytical workflows at https://www.qiagen.com/applications/cancer-research/aacr-2024-annual-mee... .

MyBio Are the New Exclusive Partner for QIAGEN in Ireland & Northern Ireland

Retrieved on: 
Wednesday, March 27, 2024
Research, Public Policy, Government, Other Natural Resources, Biotechnology, White House, Federal Government, Health, Agriculture, Natural Resources, Science, Other Science, Partnership, HID, RNA, DNA, IVD, QDI, Protein, QIAGEN, Collection, Marketing

MyBio Ltd., an award-winning specialist Irish life science distribution partner, announces a new exclusive partnership with QIAGEN, a leading global provider, to distribute their leading Life Science “Sample to Insight” product range throughout Ireland and Northern Ireland with effect from April 1st, 2024.

Key Points: 
  • MyBio Ltd., an award-winning specialist Irish life science distribution partner, announces a new exclusive partnership with QIAGEN, a leading global provider, to distribute their leading Life Science “Sample to Insight” product range throughout Ireland and Northern Ireland with effect from April 1st, 2024.
  • This exclusivity refers to Life Science products for the respective customer base and does not extend to other product portfolios of QIAGEN such as IVD regulated products, HID, Instrument Service or QDI products or customer segments.
  • This new partnership extends QIAGEN’S reach into the Irish life science market by leveraging MyBio Ltd.’s strong commercial presence and deep ties within the Academic, Biopharma and Agri-Bioscience industries in Ireland and Northern Ireland.
  • Under the terms of the agreement, MyBio Ltd. will exclusively supply the QIAGEN Life Science research product range to the academic research, biopharma, and agri-bioscience industries across the Island of Ireland.

STEMCELL Technologies Announces FDA De Novo Classification for Its EasySep™ CD138 Positive Selection Kit to Support Cancer Diagnostic Tests

Retrieved on: 
Tuesday, March 26, 2024
Oncology, Health, FDA, Medical Devices, Clinical Trials, Pharmaceutical, Biotechnology, De novo, Stemcell Technologies, Plasma, In situ hybridization, Medicine, Cell, Bone marrow, Partnership, Risk, Patient, Fluorescence, Sale, Classification, Multiple myeloma, DSM-IV codes, B cell, IVD, National Comprehensive Cancer Network, American College, European, FISH, Cancer, CD138, Multimedia, Food, Medical device

STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.

Key Points: 
  • STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit has been granted de novo classification by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
  • View the full release here: https://www.businesswire.com/news/home/20240326396951/en/
    STEMCELL Technologies is pleased to announce that its new EasySep™ Human Bone Marrow CD138 Positive Selection Kit is now classified by the U.S. Food and Drug Administration (FDA) as a first-of-its-kind in vitro diagnostic (IVD) medical device for hematopoietic cell enrichment.
  • (Photo: Business Wire)
    The kit can be used to enrich plasma cells expressing the CD138 marker (CD138+ cells) from patient bone marrow samples.
  • The EasySep™ Human Bone Marrow CD138 Positive Selection Kit will be available for sale in the United States, the European Union, Canada, and the United Kingdom.

United States In-Vitro Diagnostics Market Analysis 2023-2030: Technological Advancements Drive IVD Adoption, Enhancing Patient Outcomes Fueling Demand - ResearchAndMarkets.com

Retrieved on: 
Friday, March 22, 2024
Biotechnology, Baby, Maternity, Health, General Health, Health Technology, Medical Devices, Research, Hospitals, Genetics, Consumer, Science, Automation, PCR, Cardiovascular disease, Hematology, Haemophilia, Diabetes, Ageing, American Cancer Society, Tissue, Cancer, IVD, Leukemia, Workflow, Anemia, Blood, Medical device

The market is poised for growth with the development of automatic IVD structures that provide improved efficiency, accuracy, and throughput.

Key Points: 
  • The market is poised for growth with the development of automatic IVD structures that provide improved efficiency, accuracy, and throughput.
  • This reflects a commitment to enhancing patient care through innovative technology and positioning the United States at the forefront of the in-vitro diagnostics market.
  • Technological advancements are set to propel the United States in the in vitro diagnostics (IVD) market.
  • Instruments are predicted to be among the leading products in the United States in vitro diagnostics (IVD) market.

Beckman Coulter and Fujirebio Expand Partnership to Develop Patient-friendly, Blood-based Neurodegenerative Disease Diagnostics

Retrieved on: 
Tuesday, March 12, 2024
Research, Clinical Trials, Health Technology, Biotechnology, Biometrics, Other Health, Health, Other Science, Science, Neurodegenerative disease, Fujirebio, DirectX, Partnership, Patient, Biomarker, RUO, IVD, Beckman Coulter, Apolipoprotein E, Therapy, Physician, AFL, Amyloid, Medical imaging

Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays.

Key Points: 
  • Beckman Coulter Diagnostics, a clinical diagnostics leader, and Fujirebio, a leader in neurological markers and In Vitro Diagnostic (IVD) manufacturing, today announced an expansion of their partnership focused on development, manufacturing and clinical adoption of neurodegenerative disease assays.
  • In 2023, Beckman Coulter and Fujirebio entered into a collaboration agreement focused on new biomarkers aligned with recently approved monoclonal antibody-based Alzheimer’s disease therapeutics.
  • These new assays are being developed for use on the recently introduced Beckman Coulter DxI 9000 Immunoassay Analyzer.
  • Kevin O’Reilly, President, Beckman Coulter Diagnostics, commented, “We are very excited by our expanded partnership with Fujirebio designed to overcome challenges of developing highly sensitive assays, measuring ultra-low concentrations of neurodegenerative disease biomarkers circulating in the blood stream.”
    “Our expanded partnership with Beckman Coulter will enable increased laboratory, clinician and patient access to more neurodegenerative biomarkers around the world,” stated Monte Wiltse, President & CEO, Fujirebio Diagnostics, Inc. “We look forward to continued collaboration with Beckman Coulter bringing these critical assays to physicians and patients worldwide.”

Key Proteo Submits De Novo Application to FDA for its First Newborn Screening Kit

Retrieved on: 
Friday, March 29, 2024
Disease, WD, XLA, Infant, Patient, Classification, Mortality, Wiskott–Aldrich syndrome, RUO, IVD, Trial of the century, Proteomics, X-linked agammaglobulinemia, WAS, Hypogammaglobulinemia, FDA, DSM-IV codes, Food, Pharmaceutical industry

SEATTLE, March 29, 2024 /PRNewswire/ -- Key Proteo, a pioneering proteomics diagnostics company specializing in the enhanced early detection of rare but treatable genetic disorders, today announced that it has submitted a de novo classification request to the U.S. Food and Drug Administration (FDA) for its first in vitro diagnostic Key Proteo Newborn Screening Kit. The novel proteomics-based screening panel addresses a critical, unmet need to aid in the early identification of four treatable rare genetic disorders that current newborn screening programs do not typically test for, including Wilson Disease (WD), Wiskott-Aldrich Syndrome (WAS), X-linked Agammaglobulinemia (XLA) and Adenosine Deaminase Deficiency (ADA). Early screening has the potential to enable timely intervention that can help change the clinical trajectory and relieve the burden of disease for patients and their families afflicted by these potentially devastating disorders.

Key Points: 
  • The submission of Key Proteo's Newborn Screening Kit 1 comes after screening over 22,000 newborn samples in an ongoing pilot study in Washington state.
  • Subsequently, Key Proteo successfully completed a clinical study that included 3,294 newborn samples analyzed at 3 sites across North America.
  • The in vitro diagnostic Key Proteo Newborn Screening Kit 1 will only be available for commercialization once the FDA has completed its process.
  • Currently, Key Proteo Newborn Screening Kit 1 is available as an RUO offering.

Wireless Testing Market worth $34.1 billion by 2029 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Thursday, March 28, 2024
Health, Viavi Solutions, Transport, Statistics, WCDMA, LTE, Internet of things, Rohde & Schwarz, WLAN, Measurement, City, Code-division multiple access, Orthopedic surgery, Keysight, Region, OTA, Medicine, GSM, Wireless, Bureau Veritas, SGS S.A., WiMAX, CDMA, HSPA, UMTS, Construction, Growth, Final good, DEKRA, Telecommunications, IVD, Agriculture, Hardware, Bluetooth, Mobile phone

The Wireless network testing by equipment segment is expected to account for the largest share of the wireless testing market in 2024.

Key Points: 
  • The Wireless network testing by equipment segment is expected to account for the largest share of the wireless testing market in 2024.
  • The wireless network testing segment is a significant market for wireless testing.
  • The IT & telecommunication segment is expected to account for the largest share of the wireless testing market in 2024.
  • The Asia Pacific market is expected to witness the highest CAGR in the wireless testing market during the forecast period.

Wireless Testing Market worth $34.1 billion by 2029 - Exclusive Report by MarketsandMarkets™

Retrieved on: 
Thursday, March 28, 2024
Health, Viavi Solutions, Transport, Statistics, WCDMA, LTE, Internet of things, Rohde & Schwarz, WLAN, Measurement, City, Code-division multiple access, Orthopedic surgery, Keysight, Region, OTA, Medicine, GSM, Wireless, Bureau Veritas, SGS S.A., WiMAX, CDMA, HSPA, UMTS, Construction, Growth, Final good, DEKRA, Telecommunications, IVD, Agriculture, Hardware, Bluetooth, Mobile phone

The Wireless network testing by equipment segment is expected to account for the largest share of the wireless testing market in 2024.

Key Points: 
  • The Wireless network testing by equipment segment is expected to account for the largest share of the wireless testing market in 2024.
  • The wireless network testing segment is a significant market for wireless testing.
  • The IT & telecommunication segment is expected to account for the largest share of the wireless testing market in 2024.
  • The Asia Pacific market is expected to witness the highest CAGR in the wireless testing market during the forecast period.

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.

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.