BioPorto expects that US sales through its distribution agreement with Roche Diagnostics GmbH (Roche) will begin in the second half of 2024
BioPorto Receives FDA 510(k) Clearance for NGAL Test. (Credit: National Cancer Institute on Unsplash)
BioPorto A/S (BioPorto or the Company) (CPH:BIOPOR), today announced receipt of a US Food and Drug Administration (FDA) 510(k) clearance for BioPorto’s NGAL test, to be marketed as ProNephro AKITM (NGAL).
ProNephro AKI (NGAL) is the first Acute Kidney Injury (AKI) biomarker test cleared for pediatric use (aged 3 months through 21 years) in the US. ProNephro AKI (NGAL) is designed to help doctors identify patients at risk of developing or having persistent, moderate-to-severe AKI within 48-72 hours in the intensive care unit (ICU) setting. Unlike serum creatinine, a muscle by-product that is the current standard of care but slow to rise in AKI, NGAL is a direct real time marker of kidney cell damage and can potentially detect AKI days earlier than serum creatinine. Early detection of AKI may enable prompt intervention to save lives.
“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. “This milestone will provide the first STAT laboratory test to aid in the assessment of AKI in pediatric patients. Pediatric intensive care is a beachhead where we aim to demonstrate the life- and cost-saving value of ProNephro AKI (NGAL). Pediatric is the first segment of the $1.2 billion US and $3 billion worldwide markets1 for AKI detection.”
Mr. Pare continued, “We accomplished what we set out to do, and I am very proud of the BioPorto team that achieved this key step for the Company, hospital patients, and our shareholders.”
Until now, the risk for developing or having persistent AKI has been difficult to assess early because current standard-of-care methods, such as sCr, rise slowly in AKI. As such, ProNephro AKI (NGAL) was developed to help save kidneys and lives through faster and more timely intervention.
“Now, clinicians will have a new and biologically credible AKI test at their disposal,” said BioPorto’s Senior Medical Director and co-discoverer of NGAL, Dr. Prasad Devarajan, Professor of Pediatrics & Developmental Biology, Director of Nephrology and Hypertension, and CEO of the Dialysis Unit at Cincinnati Children’s Hospital Medical Center* (Ohio, US). “NGAL is well studied and enables a more personalized approach to the early management of AKI, as demonstrated by our extensive work in the ICU setting.”
Source: Company Press Release