Boditech Med and SphingoTec have jointly introduced a new diagnostic tool aimed at improving the detection and management of kidney function in critically ill patients.
The AFIAS sphingotest penKid assay, now commercially available, uses the biomarker Proenkephalin A 119-159 (penKid) to assess kidney function in real time. It provides clinical support in the management of acute kidney injury (AKI), particularly in patients with sepsis or septic shock.
Boditech Med CEO Eui-Yul Choi said: “We are proud to introduce the AFIAS sphingotest penKid assay to clinicians worldwide. This launch reflects our commitment to delivering innovative diagnostic solutions that address critical needs in healthcare.
“Our collaboration with SphingoTec has been instrumental in bringing this important tool to market.”
The assay, which holds an In Vitro Diagnostic Regulation (IVDR) marking, has been developed to operate as an automated fluorescence immunoassay for use in clinical laboratories.
It is designed to quantitatively determine penKid levels in human whole blood or plasma, enabling physicians to identify signs of AKI earlier than conventional methods. The technology offers a pathway for earlier intervention by detecting changes in kidney function before serum creatinine levels rise, which typically occurs later in the diagnostic timeline.
This development follows a collaboration between Boditech and SphingoTec. The agreement involves a licensing arrangement permitting Boditech to develop and commercialise assays based on penKid technology through its diagnostic platforms.
A parallel market development agreement is also in place to accelerate international rollout and clinician adoption.
SphingoTec CEO Deborah Bergmann said: “The launch of AFIAS sphingotest penKid demonstrates how partnerships can drive innovation and improve access to advanced diagnostics.
“By combining our biomarker expertise with Boditech’s diagnostic capabilities, we are reaching a new chapter in our collaboration. We are streamlining our processes to support the business of our license partners and further expand our global reach.”
PenKid is distinguished from conventional kidney function markers, such as serum creatinine, in that it offers consistent readings unaffected by inflammation, age, or comorbidities.
This independence from confounding variables allows clinicians to gain a more accurate understanding of kidney function in critically ill patients. Research has indicated that penKid can forecast deteriorating kidney performance up to two days before traditional criteria are met, supporting its role in early-stage AKI detection.
Its introduction into the clinical environment is intended to offer physicians an added layer of information during patient triage and management, particularly for those at heightened risk due to septic conditions.
By identifying kidney impairment earlier, healthcare providers may be able to initiate therapeutic interventions more effectively, potentially improving patient outcomes in intensive care settings.
