Cell Sorter Fails to Win Approval

Oncology NEWS International Vol 4 No 2, Volume 4, Issue 2

ROCKVILLE, Md--The FDA has denied a request by CellPro, Inc. (Bothell, Wash) to approve its cell sorting device Ceprate SC, used investigationally to purify bone marrow or peripheral blood autografts by concentrating CD34+ stem cells. The FDA has asked the company to provide additional information on the device.

ROCKVILLE, Md--The FDA has denied a request by CellPro, Inc. (Bothell,Wash) to approve its cell sorting device Ceprate SC, used investigationallyto purify bone marrow or peripheral blood autografts by concentratingCD34+ stem cells. The FDA has asked the company to provide additionalinformation on the device.