HERLEV, Denmark, Nov. 11, 2024 /PRNewswire/ -- Nordic Bioscience, a leading biomarker company, announced that its CPa9-HNE biomarker assay received a Letter of Support (LoS) from the U.S. Food and Drug Administration (FDA).
For the past thirty years, Nordic Bioscience has continuously advanced its ProteinFingerprint Biomarker Technologyâ„¢, driven by its scientific breakthroughs published in high-impact journals, ongoing enhancements to its high-precision automated instruments[1], and consistent regulatory approvals from official authorities.
"This trifecta of scientific excellence, high-quality biomarkers, and regulatory support sets us apart from the competition" commented Morten A. Karsdal, CEO of Nordic Bioscience. "The CPa9-HNE Letter of Support is not only another landmark achievement signifying our success story, but also something that our hard-working teams can be very proud of."
The CPa9-HNE biomarker measures a fragment of calprotectin S100a9, produced by human neutrophil elastase. It is detected in the serum and plasma of individuals with inflammatory bowel disease (IBD) and quantifies activated neutrophils, offering a non-invasive indicator of disease activity. In IBD trials, a frequent drug evaluation target is treating patients with moderate to severe ulcerative colitis or Crohn's disease. Neutrophils are important immune cells contributing to IBD, and CPa9-HNE can improve disease activity monitoring.
"The Letter of Supports underlines what we have sought to achieve with CPa9-HNE: this marker has the potential to be applied as a patient enriching tool for clinical trials in the future, by identifying patients more likely to have moderate or severe endoscopic disease activity" added Joachim Høg Mortensen, Scientific Director of Gastrointestinal Diseases, Nordic Bioscience. "This can significantly streamline patient recruitment, ensuring you target the right profiles. In addition, CPa9-HNE, as a serum calprotectin biomarker, provides a blood-based measure of disease activity, and has the potential to be used for monitoring of disease activity and treatment response."
Nordic Bioscience has a strong history in ECM remodeling research, earning FDA Letters of Support for its PRO-C3 and PRO-C6 biomarkers. The Company has transferred the FDA-approved bone biomarker CTX-I and fibrogenesis biomarker PRO-C3 to the Roche COBAS platform. With over 125 ELISA biomarkers developed to quantify unique ECM fragments, Nordic Bioscience's tools are used across all stages of drug development and patient selection in various diseases.
[1] CPa9-HNE is currently measured in hand-held ELISA assays, though development is ongoing for high precision automated platforms. Not for use in diagnostic procedures.
Contact: Elijah Aighobahi, eai@nordicbio.com, +45 4452 5252
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
Nordic Bioscience receives Letter of Support from the FDA for the CPa9-HNE biomarker in inflammatory bowel diseases
LAS VEGAS, Jan. 2, 2025 /PRNewswire/ -- As one of the global leaders in the display industry, KOORUI is set to unveil a range of cutting-edge products at CES 2025, showcasing advancements in both technology and user experience. These launches mark another milestone in delivering innovative display solutions to consumers. We warmly invite you to visit KOORUI at Booth #35609 in South Hall 2 of the Las Vegas Convention Center to explore these products firsthand.
The highlight of the new product lineup is the world's first consumer-grade monitor featuring an unprecedented 750Hz refresh rate. To compensate for the color defects of the TN panels, the screen uses the latest QD film with a wide color gamut solution, enabling a color gamut of up to DCI-P3 95%.
In today's esports landscape, where every frame can be a game-changer in fast-paced FPS and MOBA games, there is a growing demand on ever-smoother performance for esports players. Traditional monitors with refresh rates of 144Hz, 240Hz, or even 480Hz are no longer sufficient to meet the expectations of top-tier gamers. KOORUI's new gaming monitor shatters these boundaries, delivering an exceptional 750Hz refresh rate that brings next-level visual fluidity. KOORUI has scheduled the mass production of this model in 2025, with a global launch planned.
Product Specifications:
MOD
KOORUI G7
Display Type
TN
Screen Size
24.5-inch
Resolution
FHD
Color Gamut
DCI-P3 95%
Refresh Rate (Max.)
750Hz
Response Time
0.5ms
HDR
HDR 400
In addition to unveiling new products, KOORUI will also showcase its popular featured lineup at CES 2025, including OLED gaming monitors such as the OG32UK (a 480Hz UHD gaming monitor) and the GS49UK (a 49-inch DQHD ultra-wide gaming monitor with a high fresh rate).
Leveraging its parent company - HKC's robust supply chain and proprietary glass manufacturing facilities, KOORUI will also exhibit a range of cost-effective monitors tailored for bulk procurement needs.
About KOORUI
KOORUI is an innovative tech and lifestyle brand under HKC, a leading powerhouse in China's semiconductor display industry. Founded on May 4, 2021, coinciding with Youth Day, KOORUI is dedicated to the design, research, development, and sales of smart hardware and consumer electronics.
Leveraging its parent company's extensive expertise in R&D, raw materials, design, and craftsmanship, KOORUI combines high-quality customer service, efficient supply chain management, and cost optimization to deliver exceptional products. This holistic approach has established KOORUI as a globally recognized brand in the consumer electronics industry. Known for their impressive refresh rates, superior graphic quality, and innovative designs, KOORUI monitors have gained the trust of gamers, designers, and office users alike. With a philosophy of "Pragmatism, Integrity, Innovation, and Pursuit of Excellence", KOORUI is committed to delivering exceptional visual experiences with its advanced technology and user-oriented features.
With over 6 million units shipped annually and a robust global marketing network, KOORUI has established a strong presence across North America, Europe, Asia-Pacific, and the Middle East.
To learn more about KOORUI's innovative technologies, visit our booth at CES 2025 or explore our official website at koorui.net.
Social Media:
Facebook: @Kooruimall
Twitter: @Kooruimall
Instagram: @Koorui_official
Tiktok: @Koorui_official
Youtube: @Koorui_official
CONTACT: support@koorui.net
** The press release content is from PR Newswire. Bastille Post is not involved in its creation. **
KOORUI to Unveil the World's First Monitor with a 750Hz Refresh Rate at CES 2025
