Response guided therapy for hepatitis C (HCV) patients
Roche provides peginterferon alfa-2a and ribavirin combination therapy for chronic HCV infection and its cobas® diagnostic tests can be used to determine the duration and dosage of therapy.
The results of these tests allow healthcare professionals to identify the sub-type of infecting HCV and the amount of that virus in the patient’s blood so they can tailor treatment to specific sub-groups of patients.
This early detection of HCV infection is vital if healthcare professionals are to provide consolidated care of acute and chronic infection - and adequate treatment of drug response monitoring is crucial to overall therapy success.
Patients undergoing a peginterferon alfa-2a and ribavirin therapy can be accurately monitored by real-time PCR measurement. The Elecsys® anti-HCV II immunoassay on cobas e modules is a cutting-edge tool for the early, qualitative detection of antibodies against HCV.
Following the identification of HCV antibodies, testing for HCV RNA - which is a crucial marker in the management of hepatitis C - confirms the infection and aids clinicians in predicting treatment response.
In December 2011, Roche received the CE mark for its HCV RNA qualitative and quantitative tests, which enable the detection of HCV RNA and viral load measurement for predicting drug response via the cobas AmpliPrep/ cobas TaqMan® fully automated platform.
Treating skin cancer
Skin cancer therapy is the latest example of Roche successfully combining accurate molecular diagnosis with targeted therapy.
Scientists first discovered the existence of a mutated gene in metastatic melanoma cells back in 2002. This gene causes uncontrolled division of the skin cells and has been detected in approximately half of all skin cancer patients since that time.
When this new molecular-biological information was established, Roche and Plexxikon (a member of the Daiichi Sankyo Group) worked together to develop a new active substance which attacks the protein product of the mutated gene.
A clinical study published in June 2011 shows that the new active substance can directly prolong the survival of patients suffering from a metastatic melanoma with the mutation described above.
At the same time, Roche developed a test to detect this mutation in the tumour at a molecular level, identifying patients who are likely to respond to targeted therapy with the new active substance.
Guided treatment for patients with heart failure
Heart failure is characterized by a reduction in quality of life, frequent hospitalization, complex therapy, increasing cost and high mortality.
Recent clinical trials, such as PROTECT (Pro-BNP outpatient tailored chronic heart failure therapy), suggest that heart failure management can be improved by adjusting therapy based on the blood level of the biomarker NT-proBNP, the Elecsys proBNP test from Roche. In 2011, the results of this study showed that an NT-proBNP guided treatment strategy in patients with heart failure was associated with a significant reduction in total cardiovascular events and improved quality of life.
It is hoped that a new study - the GUIDE-IT (Guiding evidence based therapy using biomarker intensified treatment) study - will further validate the hypothesis that monitoring with NT-proBNP in combination with practice guideline-based care can delay heart failure hospitalization, improve quality of life and decrease mortality rates.
The study will be conducted in approximately 35 clinical centers in the United States and the results could lead to a US Food and Drug Administration (FDA) claim for therapy guidance and acceptance in medical guidelines.