- The new tests can support clinical decision making when prescribing direct oral anticoagulants for stroke prevention
- Increased testing 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
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.