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FDA-approved companion diagnostic

INNOVANCE Antithrombin

Automated chromogenic factor Xa–based assay that quantifies antithrombin activity in citrated plasma to detect AT deficiency and support therapy monitoring.

IVD-developed CDxMethod: Chromogenic AssaySpecimen: PlasmaBiomarker: Functionally active Antithrombin III
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Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
K242952
Supplements
Manufacturer
Siemens Healthcare Diagnostic Products GmbH
Approval date
March 28, 2025
Test specifications
Methodology
Chromogenic Assay
Specimen
Plasma
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
Functionally active Antithrombin III
What this test is

INNOVANCE Antithrombin is a liquid, ready-to-use chromogenic assay for automated quantitation of functionally active antithrombin in human citrated plasma. Using a human factor Xa–based activity principle, it provides precise AT levels to aid in diagnosing inherited or acquired antithrombin deficiency and in monitoring antithrombin activity for patients receiving hemophilia prophylaxis regimens.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Hemophilia A patients with or without factor VIII inhibitors and Hemophilia B patients with or without IX inhibitorsAntithrombin IIIFunctionally active Antithrombin IIIQFITLIA

IVD Manufacturer

Siemens Healthcare Diagnostic Products GmbH

Siemens Healthineers pioneers breakthroughs in healthcare. For everyone. Everywhere. Sustainably. The company is a global provider of healthcare equipment, solutions and services, with activities in more than 180 countries and direct representation in more than 70. The group comprises Siemens Healthineers AG, listed as SHL in Frankfurt, Germany, and its subsidiaries. As a leading medical technology company, Siemens Healthineers is committed to improving access to healthcare for underserved communities worldwide and is striving to overcome the most threatening diseases. The company is principally active in the areas of imaging, diagnostics, cancer care and minimally invasive therapies, augmented by digital technology and artificial intelligence. In fiscal 2025, which ended on September 30, 2025, Siemens Healthineers had approximately 74,000 employees worldwide and generated revenue of around €23.4 billion.

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If your organization is connected to Casandra, you can place an electronic order forINNOVANCE Antithrombin directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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