BioPorto's ProNephro AKI™ Test Now Available in US Labs
BioPorto's Innovative Kidney Diagnostic Launches in US
BioPorto A/S, a pioneering in vitro diagnostics firm, has made significant strides in the medical field with the commercial launch of its ProNephro AKI™ (NGAL) test, aimed at the early detection of Acute Kidney Injury (AKI) in the United States. This milestone is a result of the collaborative efforts between BioPorto and Roche Diagnostics, marking a notable advancement in kidney health technology.
Advancing Kidney Health with Collaboration
The partnership with Roche Diagnostics represents BioPorto's first major commercial initiative, facilitating the adoption of ProNephro AKI across various hospital institutions in the US. This groundbreaking test has received FDA 510(k) marketing clearance and is compatible with Roche’s advanced cobas® c 501 analyzers, widely utilized for in vitro diagnostic tests aimed at optimizing patient care in hospital settings.
Why ProNephro AKI™ Stands Out
What makes ProNephro AKI (NGAL) particularly noteworthy is its designation as the first AKI biomarker test approved for pediatric usage in the US, applicable to patients aged three months to 21 years. This test is engineered to assist healthcare professionals in swiftly identifying patients at risk of developing or having moderate to severe AKI within the first 48-72 hours of their ICU stay. Given its capability to directly measure kidney cell damage, NGAL demonstrates sensitivity in detecting kidney damage significantly ahead of traditional serum creatinine tests.
The Importance of Early Detection
Timely identification of AKI is crucial as it empowers healthcare providers to undertake prompt intervention that could potentially save lives. ProNephro AKI (NGAL) serves as a vital tool for clinicians, offering an additional resource to diagnose AKI sooner, ultimately enabling informed and potentially life-saving medical decisions.
Leadership Insight on the Milestone
Jennifer Zonderman, BioPorto’s Senior Vice President of Global Marketing & Commercialization, highlighted the significance of this achievement, stating, "We have crossed another significant milestone in our journey towards building a commercial platform for kidney diagnostics. Our go-to-market strategy is supported by robust research surrounding NGAL, which has captured high interest and positive feedback from clinicians in practice. This ability to stratify risk allows for personalized medicine approaches for kidney health, catering to varied patient needs. Looking ahead, we are excited to meet the increasing demand for ProNephro AKI in our shared customer base."
Future Expansion and Ongoing Commitment
BioPorto is committed to raising awareness and enhancing education about kidney health through targeted programs aimed at US clinicians and researchers. The company is set to engage actively at major scientific nephrology and critical care conferences, ensuring that laboratory professionals gain access to the latest developments.
Next Steps for ProNephro AKI (NGAL)
Looking towards the future, BioPorto continues to expand the ProNephro AKI (NGAL) product line. Significant upcoming milestones include the integration of ProNephro AKI with additional standard lab chemistry instruments, including the cobas c 502 and Pure models. Furthermore, they anticipate the initiation of patient enrollment for studies validating the use of ProNephro AKI in the adult demographic, striving for FDA clearance for use in individuals aged 22 and older.
About Acute Kidney Injury
Acute kidney injury is a severe condition characterized by a sudden decline in kidney function, which can manifest within a matter of hours or days. This condition leads to an accumulation of waste products in the blood and can disrupt the delicate balance of bodily fluids. AKI poses significant risks, particularly in intensive care settings, as it can cause complications in other vital organs such as the brain and heart. Early intervention is critical for improving patient outcomes.
About BioPorto
BioPorto is dedicated to enhancing patient care through innovative kidney health diagnostics. The company actively engages in developing actionable biomarkers designed to assist clinicians in managing patient care effectively. With a strong focus on meeting significant unmet medical needs, BioPorto's products leverage advanced assay development to introduce impactful solutions aimed at improving clinical and economic outcomes within the healthcare system, particularly in addressing the challenges associated with Acute Kidney Injury (AKI).
Frequently Asked Questions
What is the ProNephro AKI™ test?
The ProNephro AKI™ test is designed for the early detection of Acute Kidney Injury (AKI), utilizing the NGAL biomarker to assess kidney function rapidly.
Who can use the ProNephro AKI™ test?
This test can be used for patients ranging from three months to 21 years of age, with ongoing efforts to gain clearance for adult patients as well.
How does the ProNephro AKI™ test improve patient outcomes?
By enabling earlier detection of AKI, this test allows healthcare providers to intervene more rapidly, reducing the risk of severe complications and improving recovery prospects.
Why is BioPorto significant in the kidney diagnostics field?
BioPorto leverages extensive research and expert development in kidney biomarkers, aiming to enhance clinical decision-making and patient management.
What next developments can we expect from BioPorto?
BioPorto is expected to expand their product line further and advance research for adult AKI testing, enhancing their commitment to improving kidney health diagnostics.
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