October 27, 2022
Press release
BioPorto Exhibiting NGAL Biomarker at ASN Kidney Week – Antibodies, ELISA kits, and Clinical Chemistry Assays for Early Drug Development and Clinical Research
COPENHAGEN, DENMARK and BOSTON, MA, USA, October 24, 2022, (GLOBE NEWSWIRE) -- BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced it will showcase its NGAL biomarker for acute kidney injury (AKI) research (clinical chemistry assay, ELISA kits, and antibodies) at booth #2734 during the world’s premiere nephrology conference, ASN Kidney Week, November 2-6, 2022, in Orlando, Florida.
BioPorto’s exhibition follows the June 2022 announcement that BioPorto achieved targeted subject enrollment for the third part of a 3-part clinical study to support a US Food and Drug Administration (FDA) De Novo submission for use of a neutrophil gelatinase-associated lipocalin (NGAL) test designed to assess the risk of moderate/severe Acute Kidney Injury (AKI) in critically ill patients (3 months to 22 years) Iin the first 24 hours of ICU admission. As previously announced, based on the quality of the clinical data and other material to support the desired claims, BioPorto anticipates submission of its De Novo application to the FDA by the fourth quarter of 2022.
The NGAL TestTM is CE marked and available for in vitro diagnostic use in the European Union; registered in several countries, and available for Research Use Only in the United States. The NGAL biomarker is one of six urinary biomarkers in the FDA's Center for Drug Evaluation and Research’s (CDER) kidney safety composite measure. CDER encourages safety biomarkers for monitoring drug-induced renal tubular injury in early clinical drug development.
Meet with BioPorto at booth #2734 during Kidney Week 2022 to learn more.
For product information, please contact:
Commercial/product team, NGAL@bioporto.com, 844-424-6767
For investor inquiries, please contact:
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 is The NGAL Test, which has been 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. The NGAL Test is CE marked and registered in a number of 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.
Forward-looking statement disclaimer
Certain statements in this news release are not historical facts and may be forward-looking statements. Forward-looking statements include statements regarding the intent, belief or current expectations with respect to the Company’s expectations, intentions and projections regarding its future performance, anticipated events or trends and other matters that are not historical facts, including with respect to potential FDA marketing authorizations, implementation of manufacturing and quality systems, commercialization of tests, and the development of future products and new indications. These forward-looking statements, which may use words such as “aim”, “anticipate”, “believe”, “intend”, “estimate”, “expect” and words of similar meaning, include all matters that are not historical facts. These forward-looking statements involve risks, and uncertainties that could cause the actual results of operations, financial condition, liquidity, dividend policy and the development of the industry in which the Company’s business operates to differ materially from the impression created by the forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Given these risks and uncertainties, prospective investors are cautioned not to place undue reliance on forward-looking statements. Forward-looking statements speak only as of the date of such statements and, except as required by applicable law, the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Factors that may impact BioPorto’s success are more fully disclosed in BioPorto’s periodic financial filings with the Danish Financial Supervisory Authority, particularly under the heading “Risk Factors”.
