FDA Clears Beckman Coulter’s Osteoporosis Blood Test – (05-20-00)

FDA Clears Beckman Coulter’s Osteoporosis Blood Test

What amazes me about this is that several labs in the country have been running tests for bone turnover for YEARS now!! And, even better, they use urine to test the rate at which bone is being broken down. The US Food and Drug Administration (FDA) has granted 510(k) marketing clearance to Beckman Coulter for its Access Ostase blood test for use in managing osteoporosis and Paget’s disease. The new test, known in the industry as a “bone turnover marker,” will be the first automated, serum-based assay sold and updates the firm’s own manual assay, the Hybritech Ostase Test, Beckman Public Affairs Associate Jobe Dubbs told Reuters Health.