The First FDA-Cleared Biomarker Assay for Pediatric AKI
ProNephro AKI (NGAL) for risk assessment
A Critical Addition to Acute Kidney Care
ProNephro AKI (NGAL) provides an additional data point for clinicians to identify patients aged 3 months through 21 years at risk of developing or having persistent, moderate-to-severe AKI within 48-72 hours after intensive care unit (ICU) admission.
Make complex and potentially life-saving care decisions earlier and more confidently.
Cardiovascular
compromise
Respiratory
compromise
Solid organ
transplant
BONE marrow
transplant
Capitalize on the Window of Clinical Intervention
The NGAL biomarker rises rapidly in response to kidney injury, preceding changes in creatinine by as much as 2 to 3 days.i
By identifying patients at risk of AKI early, clinicians can take more appropriate action to manage fluid levels, avoid nephrotoxic agents, and potentially prevent permanent kidney damage.i
US Commercial Availability Expected in 2024
ProNephro AKI (NGAL) will be distributed through Roche Diagnostics. Join our mailing list to stay updated on product availability.
Identify AKI Days Earlier than SCr
Acute Kidney Injury (AKI) is difficult to assess early because the current standard of care relies on changes in serum creatinine (SCR) and urine output, physiologic endpoints that are delayed, non-specific, and impacted by extrarenal factors such as nutrition status and muscle mass.ii
“I have changed my management decisions on rounds and definitely changed the way I approached different patients based on NGAL results.”
About the Assay
A particle-enhanced turbidimetric immunoassay for the in vitro quantitative determination of neutrophil gelatinase-associated lipocalin (NGAL).
Sample type
3 µL urine
Assay run time
~ 10 minutes on Roche cobas c 501 analyzer
Result availability
Similar to a comprehensive metabolic panel; varies according to your laboratory’s collection and processing schedule