November 1, 2023
News Release
BioPorto Announces Two Poster Presentations at ASN Kidney Week 2023 Conference
COPENHAGEN, Denmark and BOSTON, MA, USA, November 1, 2023, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto or Company) (CPH:BIOPOR), an in vitro diagnostics company focused on empowering the early detection of Acute Kidney Injury (AKI), announced today that, that it will present two poster presentations at the upcoming American Society of Nephrology (ASN) Kidney Week 2023. Both poster presentations can be requested on the “Publications” section of BioPorto’s corporate website by industry professionals at ASN Kidney Week 2023.The Kidney Week 2023 Annual Meeting will take place in-person from November 2-5, 2023, in Philadelphia, Pennsylvania.
These studies have been submitted to the FDA for consideration of a 510(k) regulatory pathway marketing clearance for a BioPorto’s NGAL test submitted in September 2023. If the FDA grants BioPorto marketing authorization for an NGAL test, it would be the first commercially available biomarker test for assessing the risk of having Acute Kidney Injury (AKI) in pediatric patients in the US.
Abstract 1 presents data from GUIDANCE, a prospective, observational clinical study to validate the performance of NGAL in pediatric patients at risk of developing severe to moderate AKI within 48 to 72 hours of ICU admission. Abstract 2 characterized reference intervals for NGAL in healthy pediatric and adult patients, aged 3 months to greater than 65 years of age. These data will be used by laboratories to understand the upper and lower limits of NGAL values as measured in healthy patients using BioPorto's NGAL test. The data assists clinicians with interpreting results of an NGAL test.
Abstract Summary/Details:
Abstract #1: GUIDANCE: Primary results of a prospective, observational clinical study evaluating the performance of NGAL in the risk assessment of acute kidney injury (AKI) in pediatric intensive care unit patients
Presenter: Stuart L. Goldstein, MD, FAAP, FNKF, director of the Center for Acute Care Nephrology at Cincinnati Children's Hospital Medical Center is noted in the ASN program; due to a conflict the poster will be presented by Tabari Baker, PhD, BioPorto’s Vice President of Global Medical Affairs
Session: Pediatric Nephrology
Date: November 2, 2023
Time: 10:00 AM ET - 12:00 PM ET
Location: Exhibit Hall, Pennsylvania Convention Center
Abstract #2: Determination of Urinary NGAL Reference Intervals from Specimens of Healthy Adult and Pediatric Individuals
Presenter: Tabari Baker, PhD, BioPorto’s Vice President of Global Medical Affairs
Session: AKI: Biomarkers, Imaging, Interventions
Date: November 4, 2023
Time: 10:00 AM ET - 12:00 PM ET
Location: Exhibit Hall, Pennsylvania Convention Center
Poster access will be made available on the “Publications” section of BioPorto’s corporate website after they have been presented at ASN Kidney Week 2023.
To subscribe to news from BioPorto, please sign up at https://bioporto.com/investor-contact/
Investor Relations Contacts
Tim Eriksen, EU Investor Relations, Zenith Advisory, +45 4529 0000, investor@bioporto.com
Ashley Robinson, US Investor Relations, LifeSci Advisors, +1 617 430 7577, arr@lifesciadvisors.com
About BioPorto
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 product, The NGAL Test™ - CE marked and registered in several countries worldwide, is designed to aid in the risk assessment of Acute Kidney Injury, a common clinical syndrome that can have severe consequences, including significant morbidity and mortality if not identified and treated early. With the aid of The NGAL Test, physicians can identify patients potentially at risk of AKI more rapidly than is possible with current standard of care measurements, enabling earlier intervention and more tailored patient management strategies.
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
