News UK

First FDA Approved DOAC Assay

US FDA Marketing Authorisation for Apixaban Diagnostic Test―The First Direct Oral Anticoagulant Test for Automated Hemostasis Systems

U.K. - October 19, 2020

Werfen has received US FDA marketing authorisation for the first direct oral anticoagulant (DOAC) test in the US market.

The HemosIL Liquid Anti-Xa test kit to measure Apixaban will be the first test of its kind commercialised in the US. The test is already available in the UK, EU and other markets.

The FDA indication for HemosIL Liquid Anti-Xa has been expanded from the current quantitative determination of unfractionated heparin and low molecular-weight heparin, to include apixaban measurement, when used with HemosIL Apixaban Calibrators. The test is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information: patients at risk for major bleeding and patients experiencing a bleeding episode.

In the fight against COVID-19, we have seen anticoagulant treatments come to the fore in the prevention of COVID related thrombotic events. HemosIL Liquid Anti-Xa has provided our UK customers with accurate and reliable monitoring of Unfractionated and Low Molecular Weight Heparin and DOAC levels. With its proven track record and liquid ready to use format, this is the assay of choice for laboratories needing fast and accurate results when treating patients.

Fully validated for use on the ACL TOP® Family and ACL TOP Family 50 Series Hemostasis Testing Systems, HemosIL Liquid Anti-Xa assay for apixaban measurement delivers an automated result with excellent linearity, limit of detection, precision and accuracy, for reliable results and enhanced patient management.

More information about our range of reagents can be found via this website at the link below and by contacting or your local Area Account Manager.


Share Press Release:

LinkedIn twitter facebook

Contact Us

Contact us directly filling out the form below.

Tel: +44 (0)1925 810 141

DATA PROCESSING NOTICE: In application of the Personal Data Protection regulations (Data Protection Act 2018, we inform that your personal data will be incorporated and processed in a file under the responsibility of WERFEN for the purpose of responding to the query and fulfilling the contact us services, responding to your query. While visiting the site, you access maybe used statistical analysis and other activities related to the management of query, as well as to provide by any means (electronic or not), information responding to the query which may include if required information about our products and / or services.

Responsible for the treatment: WERFEN., with address at Werfen Ltd, 712 The Quadrant, Cavendish Avenue, Birchwood, Warrington, WA3 6DE, Company number: 01040034

Data Protection Officer:

Legal basis of processing: The data provided to Werfen is processed and held under the legal basis of informed consent​

The information you are sending us via this "Contact Us" form will be used for the sole purpose of responding to your request and, therefore, this may be transferred to other Werfen companies or subsidiaries in other countries, if required to meet that request,

Recipients or categories of recipients: Werfen companies and commercial third parties to which WERFEN . has entrusted the provision of services (hosting, training and communication services, organization of events). When legally or contractually required.

From further information around privacy please review the privacy policy on the Werfen UK website:

Term of Retention: Subsequently, once the request has been completed the data will be maintained, duly blocked, for a period of 5 years.

Rights: You can exercise the rights of access, rectification or deletion, as well as request to limit your data processing, oppose it, request the portability of your data, or revoke the consent given by writing to

​Likewise, the data subject is entitled to lodge a complaint with UK Data Protection Agency (ICO) via, Registration number: Z5683002

By clicking "I accept", you agree that your data to be processed in accordance with this notice. 

* Mandatory field