Roche launches home testing device for anticoagulant patients

Roche has launched a home self-test Bluetooth device for patients to measure blood clotting status, with results sent straight to the doctor. It will be available in all countries accepting the CE mark.

The CoaguChek INRange system measures patients' prothrombin time (PT) (also known as International Normalised Ratio – INR) levels to check on their anticoagulation status and their response to vitamin K antagonist (VKA) therapy. PT/INR levels indicate the length of time it takes for blood to clot. The measurements are then relayed directly to the patient's doctor.

Measuring PT/INR levels has been shown to significantly improve the clinical outcomes of patients on anticoagulant therapy through increased adherence and patients increasing their Time in Therapeutic Range (TTR) - i.e. the length of time a patient's PT/INR levels remain between an upper and lower target value. Having a higher TTR results in fewer incidences of stroke or bleeding.

"As healthcare systems face continued pressure to deliver improved access to care at a lower cost, increased connectivity between HCPs and patients becomes even more important," said Roland Diggelmann, COO of Roche Diagnostics. "This innovative technology continues the CoaguChek legacy of setting the standard in coagulation monitoring by providing high quality, convenient care, while optimising outcomes for patients. This is another proof point towards our aim to position patient self-testing as the standard of care to monitor VKA therapy."

The technology consists of a PT/INR measurement device and a lancing device called Softclix. The patient uses Softclix to prick the end of their finger and a drop of blood is then placed on a small test strip inserted into the CoaguChek measurement device. After approximately one minute, the patient's PT/INR levels are displayed.

Compared to the traditional method of anticoagulant monitoring – having a blood sample taken at a hospital and waiting 2-3 days for a result – self-testing devices drastically shorten the amount of time to gather the data.

Roche's CoaguChek XS platform is already available as a home test alongside Alere's INRatio device but its Bluetooth connectivity provides real-time data to doctors, giving it an edge over the competition.

"In a clinical environment, we need to establish a model of care that empowers patients, helping them to understand their health condition and allowing them to take responsibility for their own health care needs," said Juan Carlos Souto, Physician at the Hospital de Sant Pau in Barcelona, Spain. "The new technology will enable us to access the test results in the clinic's database, to keep track of the individual patient's status and to measure the quality of care provided by our clinic."