Roche's heart disease and bone tests:
This article was originally published in Clinica
Executive Summary
Roche Diagnostics has received US FDA 510(k) clearances for a new heart disease risk assay and an osteoporosis monitoring test. In heart disease, the clearance expand's the application of Roche's Elecsys proBNP test to use in the assessment of stable coronary artery disease risk. The test is already cleared to help diagnose individuals suspected of congestive heart failure (CHF), and as a marker of risk for acute coronary syndrome (ACS) and CHF. Roche claims its assay is the first natriuretic peptide test to receive FDA clearance for the new indication. According to the firm, over 192 million people in major countries have a high risk of developing cardiac events due to stable coronary artery disease. For osteoporosis, the FDA has cleared the firm's Elecsys N-MID test for osteocalcin, a protein found in the bone and in blood serum, which is an indicator of bone formation.
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