BioPorto Diagnostics A/S

BioPorto Diagnostics Inc. (US)

BioPorto is an in vitro diagnostics company focused on saving lives and improving the quality of life with actionable biomarkers – tools designed to help clinicians make changes in patient management. The Company uses its expertise in antibodies and assay development, as well as its platform for assay development, to create a pipeline of novel and compelling products that focus on conditions where there is significant unmet medical need, and where the Company’s tests can help improve clinical and economic outcomes for patients, providers, and the healthcare ecosystem. 

The Company’s flagship products are based on the NGAL biomarker and designed to aid in the risk assessment and diagnosis of Acute Kidney Injury (AKI), a common clinical syndrome that can have severe consequences, including significant morbidity and mortality, if not identified and treated early. With the aid of NGAL levels, clinicians can identify patients potentially at risk of AKI more rapidly than is possible with the current standard of care measurements, enabling earlier intervention and more tailored patient management strategies. The Company markets NGAL tests under applicable registrations including CE mark in several countries worldwide.

BioPorto has facilities in Copenhagen, Denmark and Boston, MA, USA. The shares of BioPorto A/S are listed on the Nasdaq Copenhagen stock exchange. For more information visit www.bioporto.com. 

To learn more about our products and their availability in your country, visit bioporto.com or follow our LinkedIn pages:

Outside the United States: https://www.linkedin.com/company/bioporto-diagnostics-a-s/

Within the US: https://www.linkedin.com/company/bioporto-diagnostics-inc-us/

Social Media Community Guidelines: https://bioporto.com/social-media/

BioPorto A/S

Happy holidays everyone. We look forward to improving kidney care in #2024.
#AKI #PICU #NGAL4kids #KidneyHealthforAll

BioPorto Diagnostics A/S
BioPorto Diagnostics Inc. (US)

HC Andersen Capital hosts CEO Tony Pare with an update for the #investor community, addressing the common questions related to the FDA’s clearance of ProNephro AKI™ (NGAL) – the first biomarker assay for pediatric AKI risk assessment. #FDA #medicaldevices 
 
Watch the presentation at: https://bit.ly/48efBlU
 
Learn more about ProNephro AKI (NGAL) at: https://bit.ly/4aa7fOh

BioPorto is excited to announce that it has received FDA clearance for ProNephro AKI™ (NGAL). This is the first FDA-cleared assay for pediatric AKI risk assessment.
 
“Now, clinicians will have a new and biologically credible AKI test at their disposal,” said BioPorto’s Senior Medical Director Dr. Prasad Devarajan.
 
The road to clearance:
BioPorto’s NGAL test received FDA Breakthrough Device Designation in 2019. In 2020, at the height of COVID, the BioPorto team conducted a reference range study with local events across the USA – thank you to our families, friends, and new believers in saving kidneys. Thanks to 16 US children’s hospitals and their committed staff, the EARNEST cutoff study and GUIDANCE clinical trial with 660 patients enrolled were completed.
 
Extensive studies were run, and many reports were created by BioPorto’s R&D, medical, clinical and regulatory employees (past & present), culminating in a pediatric FDA De Novo submission in November 2022. Additional information was provided to FDA in June 2023 and in September 2023, the regulatory pathway was changed to a 510(k).
 
We recognize and appreciate our investors for their loyalty and financial support throughout the entire journey to FDA clearance.
 
Next step: US commercialization:
 “With the FDA’s 510(k) clearance for ProNephro AKI (NGAL) on the Roche cobas® c 501 analyzer, we are excited to launch BioPorto’s US commercialization efforts,” said Tony Pare, BioPorto’s Chief Executive Officer.

Learn more about ProNephro AKI at https://lnkd.in/e9HrtPZw

Nis Glavind Kruse and Helle Helena Kirkemann remind us that, “Thanksgiving is a universal value we can all embrace.” BioPorto gives thanks to our diverse and talented team, our loyal customers, investors, researchers, and clinicians, and our innovative and impactful NGAL products.

Happy Thanksgiving from the BioPorto team!
BioPorto Diagnostics Inc. (US)
BioPorto Diagnostics A/S


Congratulations to our #CEO Tony Pare on his profile in Insights Care. Tony’s #leadership in bringing #diagnostics to market is valued during this exciting time for the company. #medicaldevices 
https://bit.ly/47EESFC

BioPorto Diagnostics A/S
BioPorto Diagnostics Inc. (US)
 

BioPorto A/S, an in-vitro diagnostics company, provides biomarker tests and tools, and antibodies for clinicians and researchers in Europe, North America, Asia, and internationally. It offers the neutrophil gelatinase-associated lipocalin test, a quantitative particle-enhanced turbidimetric immunoassay designed to run on automated chemistry analyzers; monoclonal antibodies for scientific, pharmaceutical, and clinical research; and enzyme-linked immunosorbent assay kits, as well as generic rapid assay device for custom lateral flow assays. The company was incorporated in 1917 and is based in Hellerup, Denmark.

COM:BIOPORTO

BioPorto

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