NEW YORK (360Dx) – German diagnostics firm Sphingotec is using proceeds from a €20 million ($23 million) funding round announced last week to commercialize automated point-of-care versions of its biomarker tests proenkephalin (penKid) and adrenomedullin (bio-ADM).
The tests are intended for monitoring kidney function (penKid) and endothelial dysfunction (bio-ADM) to identify intensive care and emergency department patients at risk of heart failure.
The company will run the tests on the Nexus IB 10 immunoassay-based point-of-care testing platform that it acquired when it purchased Samsung subsidiary Nexus Dx for an undisclosed sum in May.
The company will focus on the European market initially and has longer term plans to enter the US market via its relationship with Ortho Clinical Diagnostics, which has a licensing agreement to run the bio-ADM assay on its automated Vitros immunoassay platform, said Deborah Bergmann, vice president of marketing at Hennigsdorf, Germany-based Sphingotec.
The penKid test measures levels of the prohormone peptide proenkephalin, while the bio-ADM assay measures the peptide hormone bioactive adrenomedullin. According to Bergmann, the pair of markers are intended to help doctors manage acute heart failure patients.
Diuretics are often used to treat congestion in heart failure patients. However, Bergmann said, these drugs can harm kidney function. "So, you really have to find the balance between kidney [function] and [reducing] congestion," she said.
Measurements of patient serum creatinine levels are commonly used to measure kidney function, but, Bergmann said, this marker is known to appear late in the process.
"It means that one of your kidneys is already not functioning [well] anymore, so you get creatinine in your blood," she said. Additionally, levels "are influenced by many factors that are not kidney-specific — like age and sex and muscle mass.
Proenkephalin, on the other hand, is a marker of kidney function, not damage, Bergmann said. "You have a biomarker that provides real-time information on how your kidney is functioning, and that will help [doctors] with treatment decisions like, for instance, adjusting the levels of a nephrotoxic drug."
The bio-ADM assay, meanwhile, can be used to monitor whether patients have residual congestion requiring additional diuretics or whether diuretic treatment can be ended.
There are several other tests on the market for predicting acute kidney injury. BioPorto Diagnostics' neutrophil gelatinase-associated lipocalin (NGAL) test is intended for detecting AKI and can pick up the condition within a few hours, as opposed to the 24 to 72 hours required by serum creatinine. The Danish firm signed a global distribution deal with Roche in February to run the test on the Cobas c 501 and c 502 analyzers. It has received the CE mark for the test and is running studies to support a US Food and Drug Administration submission.
BioMérieux in April acquired AKI testing company Astute Medical, which offers an AKI risk assessment test called Nephrocheck that measures the levels of two protein markers, insulin-like growth factor-binding protein-7 and tissue inhibitor metalloproteinase-2. The test received US FDA clearance in 2014, and while Astute struggled to drive broad adoption of the test, BioMérieux plans to offer the assay and believes it could be useful both as a test for gauging AKI risk and also for guiding sepsis treatment in combination with the company's procalcitonin assay.
Procalcitonin was originally developed as a sepsis marker by BRAHMS, which was co-founded by Sphingotec CEO Andreas Bergmann, who was the company's chief research officer.
Ms. Bergmann said that while both penKid and Nephrocheck are kidney markers for patients with AKI, they addressed two different parts of that clinical question and were not in direct competition.
The proteins measured by NephroCheck are indicative of kidney damage, while the penKid test measures kidney function both within and outside the normal range to tell doctors if function is declining or improving.
NephroCheck "is positioned for the risk prediction of AKI in acute care patients," she said, "while we are positioning penKid for the monitoring of treatment success in critical care patients."
This is a shift for the company, which several years ago was focusing on proenkephalin along with proneurotensin as markers for predicting medium-term breast cancer risk in healthy women. The company launched that test in Europe in 2015 and in the US the same year through a deal with clinical reference lab Innovative Diagnostic Laboratory, which sells it under the name BreastSentry.
However, while the test is still available, Bergmann said, it has had limited commercial success.
"This was our focus, and it is still something we are working on, but it seems like the market is not ready for this kind of testing at the moment," she said. "It is definitely where we want to go ultimately, but for now we'll focus on the acute care biomarkers."
The Nexus Dx purchase was made with this focus in mind, giving the company an automated point-of-care technology for running its acute care assays. According to Sphingotec, more than 1,000 facilities throughout Europe and the Middle East were using the platform at the time of the acquisition, running more than 100,000 tests per year.
"We saw good symbiosis in combining our markers with a point-of-care technology that was already working in routine practice," Bergmann said. She added that the company planned to open up the Nexus platform to other firms that would like to develop markers for use on the system.
Sphingotec is also developing additional markers for the platform internally, she said, noting that the company aimed to launch two new markers each year. One of the next markers it plans to bring to market is one for assessing risk of reinfarction after a heart attack.
The company has roughly 60 employees divided evenly between its German office and its Nexus Dx facility in San Diego, California, and plans to add headcount, particularly on the marketing side and for building a global distribution network, with funds from the recently closed round, Bergmann said.