Roche Launches Self-Testing Coagulation Monitor
Published: Jun 11, 2018 By Mark Terry
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Patients receive warfarin therapy for a number of indications, including atrial fibrillation (AF), deep vein thrombosis (DVT), pulmonary embolism (PE), and the presence of a mechanical heart valve (MHV). They monitor how warfarin, a blood thinner, is working by measuring the International Normalized Ratio (INR). The appropriate dose is vitally important for effective and safe anticoagulation treatment.
The CoaguCheck Vantus system is Bluetooth-enabled. It allows patients to use a smartphone or tablet with a compatible app to send their results automatically to their healthcare provider. The testing itself is performed by the patient at home with a small drop of blood from the patient’s fingertip. The device then automatically sends the information by way of wireless connectivity. There is no manual input required.
“As healthcare systems face continued pressure to deliver improved access to care at a lower cost, increased connectivity between healthcare providers and patients becomes even more important,” said Alan Wright, Roche Diagnostics’ chief medical officer, in a statement. “This innovative technology sets the standard in coagulation monitoring by providing high quality, convenient testing, while optimizing the patient result reporting workflow.”
The device should be available this summer.
The system is made up of a hand-held CoaguChek Vantus meter in combination with the CoaguChek XS PT test strips. The meter is a small handheld device designed for the quantitative measurement of INR based on a PT response using a single electrochemical test strip. The test strip contains a lyophilized reagent. The test strip has a single reaction chamber that includes both the prothrombin time reaction and an on-board quality control. The prothrombin time test reaction and on-board quality control run simultaneously. If the quality control is within limits, it is verified. If it is not within limits, the meter displays an error message and the test result isn’t reported,
The system has also added new features including medication and testing reminders.
Roche also announced today that the U.S. Food and Drug Administration (FDA) approved it and AbbVie’s combination of Venclexta and Rituxan (rituximab) to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion in patients who have received at least one previous therapy. The approval was based on data from the MURANO Phase III clinical trial, comparing Venclexta plus Rituxan to standard chemo bendamustine in combination with Rituxan.
The data was quite impressive. The Venclexta and Rituxan arm had a decreased risk of disease progression or death by 81 percent compared to the bendamustine-Rituxan arm. The overall response rate (ORR) in the Venclexta-Rituxan arm was 92 percent compared to 72 percent in the bendamustine-Rituxan combination arm.
Roche’s chief medical officer, Sandra Horning, said in a statement, “We are pleased that this approval makes Venclexta, a first-of-its-kind targeted therapy, available for more people with chronic lymphocytic leukemia whose disease has returned after previous treatment. Venclexta plus RItuxan provides a new chemotherapy-free option shown to help people live longer without their disease progressing compared to a standard-of-care therapy.”