INNOVANCE Antithrombin AssayState-of-the-art antithrombin testing

Now FDA cleared as a companion diagnostic for QFITLIA

INNOVANCE Antithrombin Assay

The INNOVANCE Antithrombin assay is a state-of-the-art reagent for the detection of congenital or acquired antithrombin (AT) deficiencies. The ready-to-use reagent offers excellent precision even in the low measuring range, provides human Xa-based activity, and demonstrates excellent sensitivity to detect antithrombin mutations.^*,1-11

NEW! The INNOVANCE Antithrombin assay is now indicated as an aid in monitoring antithrombin activity to support QFITLIA (fitusiran) dosing in adult and pediatric patients aged 12 years and older with hemophilia A or B, with or without factor VIII or IX inhibitors.^†

Features & Benefits

For ease of use, the liquid reagent uses standard calibrators and controls for simplified system adaptation.
Good method correlation across systems offers harmonized result interpretation and helps avoid the need for repeat testing, saving time and reagents.

Available in multiple ready-to-use kit sizes, reducing waste and providing cost and labor efficiencies.
Available for any sized lab on the CS-2500/CS-5100, BCS XP System, and CA-600 Systems.^†

Low variation across the measuring range even at the lower end, producing reliable test results even for low AT activity levels.
The activity assay is based on human Xa and shows outstanding performance in the detection of types I/II deficiency observed including the challenging type II HBS deficiencies.^*,^1-11

Technical Specifications

10 µL Required sample volume, depending on system application	7.3–127.9% of norm Linearity range on BCS XP System
48 hours Onboard stability on BCS XP System	5.5% CV Within-device/lab with a plasma pool at mean 14.8% of norm antithrombin activity on CS-2500 System
100/130/400 tests per kit^‡ Three kit configurations available to suit different volume needs	4 weeks Stability after reconstitution at 2–8°C
99% AT type II HBS deficiencies correctly identified Testing 643 patients with >10 different mutations^2-11	98% AT type I/II deficiencies correctly identified Testing 954 patients including >45 different mutations^2-11

Clinical Use

Monitoring antithrombin activity levels to support QFITLIA dosing

Treatment with QFITLIA (fitusiran) supports individuals living with hemophilia A or B— with or without inhibitors— by helping to rebalance one of the body’s critical clotting mechanisms to prevent bleeding. The INNOVANCE Antithrombin assay from Siemens Healthineers aids in monitoring patients’ antithrombin activity levels to support QFITLIA dosing in adult and pediatric patients aged 12 years and older.^12-15 It is the only assay cleared for this indication. Due to its high precision also in the lower measuring range, it is an ideal tool for monitoring drug therapy with QFITLIA.^†

As of today, INNOVANCE Antithrombin assay is the only FDA cleared companion diagnostic for QFITLIA. In addition to its novel use in therapeutic drug monitoring, the INNOVANCE Antithrombin assay is used to detect genetic or acquired antithrombin deficiencies.

Services & Support

Education & Training

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Please refer to the Technical Specifications section for performance details on precision, sensitivity, and detection levels.

†

The indication for use with Qfitlia has been cleared for BCS XP system.

‡

Dependent upon individual analyzer performance.

Rojnik T, et al. Comparison of antithrombin activity assays in detection of patients with heparin binding site antithrombin deficiency: systematic review and meta‑analysis. Nature Sc Rep 2023;13:16734. https://doi.org/10.1038/s41598-023-43941-x

Reda S, et al. Functional Characterization of Antithrombin mutations by monitoring of thrombin inhibition kinetics. Int J Mol Sci 2021;22:2119. https://doi.org/10.3390/ijms22042119

Puurunen M, et al. Type II antithrombin deficiency caused by a founder mutation Pro73Leu in the Finnish population: clinical picture. J Thromb Haemost 2013; 11: 1844–9. https://doi.org/10.1111/jth.12364

Javela K, et al. Great discrepancy in antithrombin activity measured using five commercially available functional assays. Thromb Res 2013;132:132–7. http://dx.doi.org/10.1016/j.thromres.2013.05.012

Gindele R, et al. Clinical and laboratory characteristics of antithrombin deficiencies: A large cohort study from a single diagnostic center. Thromb Res 2017; 160:119–128. http://dx.doi.org/10.1016/j.thromres.2017.10.023

Orlando C, et al. Antithrombin heparin binding site deficiency: A challenging diagnosis of a not so benign thrombophilia. Thrombosis Research 2015; 135:1179–85. https://doi.org/10.1016/j.thromres.2015.03.013

Cooper PC, et al. The phenotypic and genetic assessment of antithrombin deficiency. Int. Jnl. Lab. Hem. 2011, 33, 227–237. https://doi.org/10.1111/j.1751-553X.2011.01307.x

Merz M, et al. Clinical multicenter evaluation of a new FXa-based antithrombin assay. Int Jnl Lab Hem 2011;33:498–506. https://doi.org/10.1111/j.1751-553X.2011.01326.x

Kovacs B, et al. The Superiority of Anti-FXa assay over Anti-FIIa assay in detecting heparin-binding site antithrombin deficiency. Am J Clin Pathol 2013;140:675-9 https://doi.org/10.1309/AJCPVY4Z9XZMFOTH

Gindele R, et al. investigation of the differences in antithrombin to heparin binding among antithrombin Budapest 3, Basel, and Padua mutations by biochemical and in silico methods. Biomolecules 2021;11 : 544. https://doi.org/10.3390/biom11040544

Rühl H, et al. Activated Factor X-Based versus Thrombin-Based Antithrombin Testing in Thrombophilia Workup in the DOAC Era. Thromb Haemost 2018;118:381–387. https://doi.org/10.1160/TH17-08-0568

Kenet G, et al. Fitusiran prophylaxis in people with hemophilia A or B who switched from prior BPA/CFC prophylasis: the ATLAS-PPX trial. Blood. 2024;143:2256-69. https://doi.org/10.1182/blood.2023021864

Young G, et al. Efficacy and safety of fitusiran prophylaxis in people with haemophila A or haemophilia B with inhibitors (ATLAS-INH): a mutlicentre, open-label, randomized phase 3 trial. Lancet. 2023;401:1427-37. https://doi.org/10.1016/S0140-6736(23)00284-2

Srivastava A, et al. Fitusiran prophylaxis in people with severe haemophilia A or haemophilia B without inhibitors (ATLAS-A/B): a multicentre, open-label, randomized, phase 3 trial. Lancet Haematol. 2023;10: e322-32. https://doi.org/10.1016/S2352-3026(23)00037-6

Young G, et al. Safety and efficacy of a fitusiran antithrombin-based dose regimen in people with hemophilia A or B: the ATLAS-OLE study. Blood 2025, published preprint on March 7, 2025. https://doi.org/10.1182/blood.2024027008

Assay performance can vary from country to country as well as with the system application of the respective assay. The values listed above are provided as examples only.

Product availability varies from country to country and is subject to varying regulatory requirements.

CS-2500/CS-5100 Systems refer to Automated Blood Coagulation Analyzer CS-2500 and Automated Blood Coagulation Analyzer CS-5100 respectively. CA-600 Systems refer to CA-660 and CA-620 Systems. CA-660 and CA-620 Systems refer to Automated Blood Coagulation Analyzer CA-660 and Automated Blood Coagulation Analyzer CA-620 respectively.

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