Roche has launched three coagulation tests for three oral Factor Xa inhibitors namely apixaban, edoxaban and rivaroxaban, in European countries accepting the CE mark.
Factor Xa inhibitors, unlike traditional anticoagulants, are given as fixed doses without the need for coagulation testing. However, in certain situations such as during a haemorrhagic or thromboembolic event, suspected overdose, and in patients who require urgent surgery, it is necessary to conduct Factor Xa inhibitor coagulation tests to inform patient care.
Factor Xa inhibitors are prescribed for various cardiovascular indications such as non-valvular atrial fibrillation, coronary artery disease (CAD), peripheral arterial disease (PAD) and for the prevention and treatment of venous thromboembolism (VTE). The use of these therapies has increased, and these have been added to the World Health Organization (WHO)’s Model List of Essential Medicines in 2019.
Roche’s coagulation tests can be used to assess the anti-Xa activity of the three Factor Xa inhibitors along with another anti-coagulant heparin. The automated tests can be run on Cobra t analysers and are aimed at improving workflow, as per Roche.
The market for blood coagulation tests is a part of the larger haematology market. The haematology reagents and the haematology test segments are estimated to generate revenue of $3.5bn and $3.2bn by 2025, respectively, as per GlobalData market analysis.
Roche’s blood test portfolio includes multiple immunoassays such as Elecsys HBeAg quant, to diagnose and monitor hepatitis B, Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections, neurofilament light chain (NfL) test for diagnosing multiple sclerosis and the interleukin 6 (IL-6) immunoassay for diagnosing neonatal sepsis.
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Earlier this year, the company received a CE mark for the Elecsys anti-müllerian hormone (AMH) plus immunoassay as a diagnostic blood test for diagnosing polycystic ovary syndrome (PCOS). The test identifies the presence of polycystic ovarian morphology in women with suspected PCOS.
Roche has also invested in developing an automated workflow software, the Digital Pathology software platform. To that end, the company partnered with Ibex Medical Analytics and Amazon Web Services (AWS) to enable pathology laboratories to access Ibex’s AI-powered decision support tools to aid in the diagnosis of breast and prostate cancer through its Digital Pathology software platform.