Metra Biosystems Inc. received clearance to market oneof four assays it had under FDA review in the areas ofbone formation and resorption.
The Mountain View, Calif. company got clearance tomarket the Alkphase-B assay for helping in themanagement of Paget's disease of bone. Alkphase-B, abiochemical marker for bone formation, is Metra's firstassay to get regulatory approval. The product already wasbeing used by researchers in the U.S., and has beenavailable for clinical use elsewhere, including Europe.
Metra Biosystems also has 510(k) submissions filed forthree bone resorption (loss) products. All were submittedbetween April and June of this year. The bone resorptiontests include Pyrilinks Polyclonal; Pyrilinks, a second-generation monoclonal antibody-based assay; andPyrilinks-D, a bone-specific resorption marker.
Alkphase-B measures serum levels of bone-specificalkaline phosphatase (BAP), an enzyme released into thebloodstream as a result of bone formation. Themonitoring of BAP levels will help physicians evaluatethe efficacy of treatments for Paget's disease, thecompany said.
Paget's disease, in which bone is broken down and builtup at an accelerated rate, is the second most commonmetabolic bone disease, following osteoporosis. It afflictsabout 2 million to 3 million Americans.
"We finally cleared the hurdle and demonstrated we canwork within the regulatory challenges of the industry,"Ronald Steckel, the company's vice president ofdevelopment and operations, said of the clearance. "Itdemonstrates another commitment Metra made to themarket that we delivered." n
-- Jim Shrine
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