Innovative anti-Xa assay sets new standard in anticoagulant diagnostics

An innovative and flexible anti-Xa assay streamlines workflows, reduces errors, and upholds top-quality standards, setting a new benchmark in anticoagulant testing.

Managing anticoagulant therapies is a delicate balancing act. Too much of these life-saving medications can cause dangerous bleeding, while too little increases the risk of potentially fatal blood clots. For clinical laboratory staff tasked with anticoagulant testing monitoring, the challenge has grown even more complex with the rise of direct oral anticoagulants (DOACs).

The INNOVANCE Anti-Xa assay is a diagnostic tool designed to streamline anticoagulant therapy management while ensuring accuracy and reliability. To learn more about its development and impact, SelectScience^® spoke with Dr. Matthias Wilkens, Senior Manager Assay Development, Siemens Healthineers. With extensive experience in assay development, Dr. Wilkens sheds light on how this innovation is helping labs meet the evolving needs of modern medicine.

What makes the INNOVANCE Anti-Xa assay stand out?

The INNOVANCE Anti-Xa assay is a chromogenic in vitro diagnostic test designed to measure anticoagulants that target Factor Xa, a key component in the blood clotting process. It was initially developed for monitoring the activity of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH). Its scope has since expanded to include the quantitative measurement of DOACs such as rivaroxaban,* apixaban, and edoxaban.*

This adaptability is one of the key factors that sets the assay apart. “We use the same assay principle and reagent for both heparins and the DOACs,” Dr. Wilkens explains. “This means labs don’t need separate reagents for each type of anticoagulant.”

Such versatility is crucial as DOACs become more prevalent in clinical practice. Unlike vitamin K antagonists, these medications generally don’t require routine monitoring. However, certain situations—such as emergency surgeries, suspected overdoses, or drug interactions—necessitate precise testing to manage risks and guide interventions.

The challenges of traditional anticoagulation assays

For years, tests such as the activated partial thromboplastin time (APTT) assay were the standard for monitoring heparin therapy. While these methods served their purpose, they often came with drawbacks. “APTT testing suffers from high variability, and its sensitivity to heparin can differ greatly depending on the reagent used,” Dr. Wilkens said.

These inconsistencies can make it challenging to maintain stable anticoagulation levels, leading to frequent dosage adjustments and additional blood draws. For DOACs, the limitations are even greater—routine tests such as APTT and prothrombin time (PT) may not be sensitive or specific enough to measure these newer drugs accurately. Prolonged results may also be caused by defects of coagulation other than the drug taken by the patient.

The INNOVANCE Anti-Xa assay solves these problems by delivering consistent, precise results. By directly measuring the activity of Factor Xa inhibitors, it ensures a stable and reliable approach to managing anticoagulant therapies.

Anti-Xa assay usability designed for real-world labs

Laboratories are often challenged by the complexity of anticoagulant testing, as the need for multiple reagents, calibration curves, and preparation steps can disrupt workflows and increase the risk of errors. Recognizing these challenges, Siemens Healthineers designed the INNOVANCE Anti-Xa assay with usability in mind.

One standout feature is its single calibration curve for the heparins. Traditional assays often require separate calibration for different types of heparins, which can be time-consuming and prone to errors. “With a single calibration curve, labs can simplify workflows and reduce risks,” says Dr. Wilkens. “It also eliminates the need to verify which type of heparin the patient is using.”

The assay is ready to use, and liquid reagents further enhance its practicality. Unlike other assays that require reconstitution or equilibration, the INNOVANCE Anti-Xa assay is always ready to go. “There’s no waiting time, no preparation required, and therefore less hands-on time needed,” Dr. Wilkens explains. “This means testing can begin immediately, even in urgent situations.”

The reagent’s eight-week, once-open stability also reduces waste, while the streamlined design allows for efficient integration into any lab regardless of size or testing volume.

Quality and precision backed by international standards

One of the most critical aspects of any diagnostic assay is its adherence to quality and regulatory standards. The INNOVANCE Anti-Xa assay excels in this regard, aligning with both international and local requirements.

“For heparin calibrators and controls, we ensure traceability to the World Health Organization (WHO) standards,” says Dr. Wilkens. “For DOACs, we use high-purity, in-house preparations to create standards and controls, ensuring consistent quality.”

This commitment to precision is particularly important as regulatory frameworks, such as the European In Vitro Diagnostic Regulation (IVDR), become more stringent. “With the INNOVANCE Anti-Xa assay, Siemens Healthineers has been at the forefront of meeting these requirements,” Dr. Wilkens adds. Moreover, the assay has recently achieved FDA 510(k) clearance in the U.S., further demonstrating its reliability and compliance.

Why anticoagulant testing matters

Anticoagulant therapies, whether using heparins or DOACs, come with inherent risks and require careful management. These risks can vary widely based on individual factors such as age, weight, renal function, and comorbidities. Accurate testing is essential to tailor treatments and avoid complications.

For heparins, the variability in patient response makes quantification critical. Dr. Wilkens explains, “identical doses of heparin can have very different effects depending on the patient’s condition.” DOACs, while often marketed as “no-monitoring-needed” drugs, still require testing in certain scenarios, such as emergency interventions, suspected overdoses, or acute bleeding of unknown cause.

The INNOVANCE Anti-Xa assay provides reliable quantification, offering results in international units per milliliter for heparins and nanograms per milliliter for DOACs. This level of accuracy ensures clinicians have the data they need to make informed decisions, improving patient outcomes and reducing risks.

A unified solution for the future

As the use of DOACs continues to grow, the demand for precise and efficient testing solutions will only increase. The INNOVANCE Anti-Xa assay is well-positioned to meet these needs, offering a unified platform for testing both heparins and DOACs with ease and reliability.

“Prescription rates of vitamin K antagonists are steadily declining, while the number of patients on DOACs continues to rise,” Dr. Wilkens explains. “This shift significantly impacts coagulation testing, as DOACs can interfere with other coagulation tests, potentially causing misleading results if clinicians are unaware of the patient’s anticoagulant use. Given the growing use of DOACs, the need for accurate drug testing is more important than ever.”

By simplifying workflows, reducing errors, and adhering to the highest quality standards, the INNOVANCE Anti-Xa assay is setting a new benchmark in anticoagulant therapy management. For labs of all sizes, it represents, not only an advancement in technology, but also a practical, real-world solution for a complex and critical area of diagnostics.

Find out how you can simplify your anticoagulant testing with the INNOVANCE Anti-Xa assay.

*Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.

The products/features are not commercially available in all countries. Due to regulatory reasons, their future availability cannot be guaranteed. Please contact your local Siemens Healthineers organization for further details.

All trademarks are the property of their respective owners.