Beckman's Access Ostase blood test gets US FDA go-ahead:
This article was originally published in Clinica
Executive Summary
Beckman Coulter has received US FDA 510(k) clearance to market what it claims is the first automated serum-based blood test in the US that can help manage osteoporosis and Paget's disease. The Access Ostase assay, which is available on the company's Access Immunoassay system, is less expensive than bone mineral density tests that are traditionally used to measure the effectiveness of osteoporosis therapy, said the company.