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Beckman Coulter Diagnostics, SphingoTec Ink Agreement on Acute Kidney Injury Test

NEW YORK – Beckman Coulter Diagnostics and SphingoTec said Wednesday that the firms have formed a partnership to make a biomarker of acute kidney injury available for high-throughput testing in central labs.

SphingoTec's penKid assay is used to measure Proenkephalin 119-159 in plasma to aid the assessment of kidney function and the diagnosis of kidney injury. Under the agreement, Beckman Coulter will develop and validate a fully automated diagnostic test for penKid for use on its Access family of immunoassay analyzers.

Financial and other terms of the deal were not disclosed.

"Acute kidney injury exerts a profound impact on patients globally, complicates acute and chronic illnesses frequently resulting in poor outcomes, and rivals many other critical diseases in its severity and consequences," Beckman Coulter President Kevin O'Reilly said in a statement. "The published evidence for penKid testing combined with SphingoTec's scientific expertise provides an exciting opportunity to improve kidney health management."

Hennigsdorf, Germany-based SphingoTec received In Vitro Diagnostic Regulation certification for the test in May 2023, and the companies said that the certified assay will be used as the basis for the test on Brea, California-based Beckman Coulter's instruments. The penKid assay is used for the early detection of kidney function decline, and the results are used to aid treatment decisions and improve patient outcomes.

SphingoTec said that its IVDR-certified penKid assay has been implemented in some university hospitals as a routine test. The company also inked a commercialization agreement last year with Boditech Med to commercialize point-of-care tests that incorporate the biomarker.