Roche launches three new Factor Xa inhibitor coagulation tests to meet growing patient need

• The new tests can support clinical decision making when prescribing direct oral anticoagulants for stroke prevention
• Increased testing is needed to meet growing demand since these anticoagulants were added to the WHO list of essential medicines
• The new assays will utilise Roche's reagent cassette concept, ensuring high quality results and efficient sample processing

ROTKREUZ, Switzerland, Feb. 12, 2024 /PRNewswire/ -- Roche announced today that it has launched three new coagulation tests for the oral Factor Xa inhibitors apixaban, edoxaban and rivaroxaban in countries accepting the CE mark¹. These anticoagulants were added to the World Health Organization's Model List of Essential Medicines in 2019² due to the positive benefits they can have for patients. The tests could support clinical decision making in patients treated with direct oral anticoagulants for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, coronary artery disease (CAD), peripheral arterial disease (PAD) and for the prevention and treatment of venous thromboembolism (VTE).

"Diseases such as CAD and PAD can have serious consequences and urgently need better diagnosis and treatment. CAD alone accounts for about one in every five deaths³ and PAD affects over 200 million adults worldwide⁴," said Frank Sieben, Head of Core Lab Customer Area at Roche Diagnostics. "These numbers and our growing understanding of these diseases are leading to a sharp rise in global demand for direct oral anticoagulants. We want to help labs meet this increased need for testing to better inform patient care. Labs will also benefit from our innovative cassette concept, which will let them bring scale and speed to testing."

These tests can be used for both assessing the anti-Xa activity of heparin therapy as well as the three authorised Factor Xa inhibitors. This will bring standardisation and automate the reconstitution process without lab user intervention, saving time for other activities. The tests can be run on indicated cobas^® t analysers and benefit from Roche's Anti-Xa innovative cassette technology. The reagent cassette concept ensures high quality of results by reducing risk of contamination and evaporation and can lead to a more optimised use of reagents.

Roche in coagulation
The Roche Coagulation journey started in the early 80's with the launch of COBAS^® FIBRO. In the 90's, the Point of Care instruments CoaguChek^® were launched and consolidated the use for INR monitoring. In 2017, Roche launched the cobas^® t 511 and cobas^® t 711 coagulation analysers for laboratories with different workflow needs; those instruments use the cassette concept for coagulation reagents which avoids manual preparation. During the last 5 years, the tests menu has been in constant expansion, showcasing the recurrent investment in lab coagulation, fulfilling our commitment to patients who live with haemostatic disorders and to the healthcare system that brings them care.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

In recognising our endeavour to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

References
[1] Roche Diagnostics. (2023). APIX, EDOX, RIVA CalSet and ControlSet Method Sheets (version 1)
[2] National Library of Medicine [internet; cited 2024, Jan 30] Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7546116/
[3] National Library of Medicine [internet; cited 2024, Jan 30] Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2787400/
[4] National Library of Medicine [internet; cited 2024, Jan 30] Available from: https://www.ncbi.nlm.nih.gov/books/NBK430745/

For further information please contact

Jonathan Parry, Roche Diagnostics Solutions
Phone: + 41 79 653 76 43
e-Mail: jonathan.parry@roche.com