Werfen and VolitionRx Partner to Advance Diagnostic Testing for Antiphospholipid Syndrome

This condition increases the risk of blood clots that can lead to stroke, heart attack, pulmonary embolism, or deep vein thrombosis. It is also associated with recurrent miscarriages and pregnancy complications. Current diagnostic methods rely on blood tests that require repeated confirmation over time, leaving a gap for improved and more efficient tools.

VolitionRx (Henderson, NV, USA), a multinational epigenetics company, has signed a research license and exclusive commercial option rights agreement for APS with Werfen’s Immunoassay Technology Center (Barcelona, Spain), a worldwide leader in specialized diagnostics. Under the agreement, Werfen will evaluate the clinical utility of Volition’s proprietary Nu.Q® NETs assay on its automated platforms. The assay focuses on detecting neutrophil extracellular traps (NETs), which play a significant role in the clotting complications seen in APS patients.

Initial technology transfer has already succeeded, with the Nu.Q® NETs assay integrated into Werfen’s ACL AcuStar® platform. Early data on NET detection in APS patients have been encouraging, showing the test’s potential as a risk indicator for thrombosis. The Nu.Q® assay represents the first CE-IVD biomarker being investigated for APS, positioning it as a potential breakthrough in disease monitoring and diagnosis.

The collaboration aims to validate the assay in larger clinical studies and determine its role in routine APS patient care. If successful, the tool could provide improved diagnostic information, enable more personalized treatments, and support long-term monitoring with a simple, low-cost blood test. This development could reduce reliance on current multi-step diagnostic protocols and enhance patient care globally.

“We believe that Volition’s Nu.Q® NETs test is the first CE-IVD biomarker being investigated in APS and could provide not only improved diagnostic information to aid clinical decision-making and personalize care, but also a low-cost test to continue to monitor these patients throughout their lifetimes,” said Remi Rabeuf, Vice President Corporate Alliances & Strategic Partnerships, VolitionRx.

“We are excited to validate further and complete a clinical utility study to determine the potential role of this marker as a risk indicator of thrombosis in APS patients, allowing a better management of this very complex syndrome,” added Marta Palicio, Werfen’s Immunoassay Technology Center Innovation R&D Director. “This could open the possibility to enlarge Werfen’s portfolio in APS testing.”

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