Eng

Abionic's CAPSULE PSP Receives FDA Approval for Early Detection of Sepsis; Fapon Introduces Exclusive PSP Solution in China via Licensing Collaboration

PR Newswire (美通社)
更新於 7小時前 • 發布於 7小時前 • PR Newswire

DONGGUAN, China, Oct. 31, 2024 /PRNewswire/ -- Fapon, a global leading life sciences company, is thrilled to announce its PSP CLIA reagent solution which demonstrates promising outcomes in extensive clinical validation studies targeting Chinese population.

Leveraging its strategic partnership with Abionic SA and LASCCO SA, Fapon has gained exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Recently, Abionic announced that its innovative sepsis early detection test, IVD CAPSULE PSP, has received 510(k) clearance from the US Food and Drug Administration (FDA). This approval marks a significant advancement in the diagnosis and treatment of sepsis.

廣告(請繼續閱讀本文)

Pancreatic Stone Protein (PSP) is an emerging sepsis biomarker used by clinicians as a screening tool for the early-detection of sepsis 24 - 48h earlier than current standards to support critical time-sensitive decisions. Produced by the pancreas and immune cells, PSP levels increase in response to infections and inflammation and has demonstrated significant sensitivity and specificity in detecting sepsis, particularly in critically ill patients. Clinical studies have shown that elevated PSP levels correlate closely with the progression of sepsis, allowing healthcare professionals to activate sepsis bundles earlier and improve outcomes.

The FDA clearance highlights the marker and test's accuracy and reliability, supported by existing certifications from the EU CE, EU IVDR, and the Australian Therapeutic Goods Administration (TGA). This sets the stage for PSP test's global implementation, emphasizing its potential impact on sepsis diagnostics.

In October 2023, Fapon entered into a strategic cooperation agreement with Abionic SA and LASCCO SA. This alliance grants Fapon exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China. Leveraging this collaboration and the test's recent FDA approval, Fapon is in the development and commercialization of PSP on its chemiluminescent immunoassay (CLIA) analyzer within the territory.

廣告(請繼續閱讀本文)

Beyond its focus in sepsis, Fapon is dedicated to advancing research in a range of critical areas, including infectious diseases, neurodegenerative disorders, anti-aging, AI-driven biomarkers and others. We continually strengthen our R&D capabilities through the establishment of global research centers, recruitment of industry-leading experts, and strategic licensing collaborations and investments in breakthrough technologies.

Moving forward, Fapon is committed to providing more innovative, high-quality IVD products and services, and bringing earlier, more accurate, more convenient, and more accessible diagnostic solutions to our partners.

About Fapon

廣告(請繼續閱讀本文)

Fapon is a global leading life sciences company dedicated to providing integrated solutions and services for diagnostics, biopharma and biotherapy. Integrating a one-stop solution on raw materials, reagents and innovative open instrument platforms, the Company has grown into a leading supplier in in-vitro diagnostics. Fapon boasts advanced innovations in therapeutics technologies and AI algorithm platforms with data insights that contribute to a better and healthier world. Supported by its strong global R&D, manufacturing, sales and service network, Fapon's products have established presence in 68 countries and regions, serving more than 2,500 business partners worldwide.

Follow us on LinkedIn (Fapon) or visit our website

查看原始文章

更多 Eng 相關文章

Japan's economy gradually recovering amid lingering stagnation: report
XINHUA
JACOB & CO. Boutique Debuts in Macao: A Perfect Fusion of Art and Luxury
PR Newswire (美通社)
Chinese table tennis great Ma Long wins ANOC Outstanding Sporting Career Award
XINHUA
Technology helps power grid prepare for peak winter season
PR Newswire (美通社)
Telix Partners with Subtle Medical on AI-Enabled SubtlePET™ Software for Faster PET Imaging with Illuccix®
PR Newswire (美通社)
Nearly 240,000 Visits Attend the Grand Event as the 31st China (Guzhen) International Lighting Fair Concludes Successfully
PR Newswire (美通社)
Xinhua Silk Road: E. China's Shanghai gears up to build digital, intelligent & green int'l shipping center
PR Newswire (美通社)
"Bleach: Brave Souls" Anime Broadcast Celebration Special: Thousand-Year Blood War Zenith Summons: Puppets Begins with Thousand-Year Blood War 2024 Versions of Giselle & Others
PR Newswire (美通社)
Youdao to Report Third Quarter 2024 Financial Results on November 14
PR Newswire (美通社)
NetEase to Report Third Quarter 2024 Financial Results on November 14
PR Newswire (美通社)
Global Times: Three taikonauts of Shenzhou-19 crew enter China Space Station
PR Newswire (美通社)
Morinaga Nutritional Foods Vietnam (MNFV), Is Strengthening Its Efforts To Respect Human Rights And Human Capital Development
PR Newswire (美通社)
Hisense named first Official Partner of the FIFA Club World Cup 2025™
PR Newswire (美通社)
Global Times: GCI spreads seeds of harmonious world by connecting cultures
PR Newswire (美通社)
FII Convenes Dialogues on Global Growth and Sustainable Innovation
PR Newswire (美通社)
Profile: Wang Haoze -- female rocket engineer launched into space
XINHUA
Haier Mix Pro14 Ultrabook: A Perfect Blend of Performance and Portability
PR Newswire (美通社)
World Insights: EU's protectionist tariffs on Chinese EVs face backlash from industry, officials
XINHUA
CStone Announces MHRA Approval of Sugemalimab for First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC) in the UK
PR Newswire (美通社)
Profile: Cai Xuzhe, returning to space 22 months after his first spaceflight
XINHUA
TECNO Pocket Go Named to TIME'S List of The Best Inventions of 2024
PR Newswire (美通社)
GLOBALink | China's eVTOL enterprise to showcase latest product at CIIE
XINHUA
Taiwan's Fintech Shines in Singapore! FinTechSpace Once Again Leads a Delegation to 2024 Singapore FinTech Festival
PR Newswire (美通社)
NTT Sparks Collaboration on AI, Drives Smart City Development at Innovation Summit
PR Newswire (美通社)
Vietnam's Marketing Future: MMA Global's Vision for a Thriving Marketing Ecosystem
PR Newswire (美通社)
THE CHILDREN'S PLACE ANNOUNCES LAUNCH OF STOREFRONT ON SHEIN
PR Newswire (美通社)
Nagarro and Marubeni Announce Global Partnership to Leverage Digital Technologies for Japanese Corporates
PR Newswire (美通社)
Full Truck Alliance Co. Ltd. to Announce Third Quarter 2024 Financial Results on Wednesday, November 20, 2024
PR Newswire (美通社)
Update: China's Shenzhou-19 spaceship docks with space station combination
XINHUA