CLIA waiver status for Osteomark NTx PoC (point-of-care) test:

The FDA has extended its clearance for Ostex International's Osteomark NTx Point-of-Care device to make it available in virtually all physicians' offices. The test, which measures cross-linked N-telopeptides of type I collagen (NTx), a marker of bone resorption, is used to monitor the effect of treatment in osteoporosis patients. It was originally approved in the US in 1999, but the FDA has now granted it Rx Home-Use clearance and CLIA waiver status. The new, wider approval will also mean the test can be distributed through pharmacies with a physician's script. The Seattle, Washington company is currently constructing a new manufacturing facility for the test, due for completion in the fourth quarter of this year.

The FDA has extended its clearance for Ostex International's Osteomark NTx Point-of-Care device to make it available in virtually all physicians' offices. The test, which measures cross-linked N-telopeptides of type I collagen (NTx), a marker of bone resorption, is used to monitor the effect of treatment in osteoporosis patients. It was originally approved in the US in 1999, but the FDA has now granted it Rx Home-Use clearance and CLIA waiver status. The new, wider approval will also mean the test can be distributed through pharmacies with a physician's script. The Seattle, Washington company is currently constructing a new manufacturing facility for the test, due for completion in the fourth quarter of this year.

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