CellaVision, Lund, Sweden has obtained FDA clearance to introduce its DiffMaster(TM) Octavia, an in-vitro diagnostic device, on the U.S. market.

DiffMaster Octavia is an automated cell-locating device for differential count of white blood cells and characterization of red morphology, today conducted through manual microscopy. It is based on a software system developed by CellaVision, combined with a sophisticated hardware platform.

The system automatically locates and presents images of blood cells on peripheral blood specimens. The operator identifies and verifies the suggested classification of each cell. DiffMaster(TM) Octavia is a powerful tool to be used by skilled operators, trained in the use of the instrument and in recognition of leukocyte classes.

"CellaVision will identify initial trial sites as well as potential distributor partners in the U.S. during this year. Sales is expected to start during 2002," says Yvonne Mårtensson, CEO at CellaVision.

There are more than 10 000 laboratories in the U.S. performing white blood cell differential counting.

DiffMaster(TM) Octavia will be exhibited both at the AACC Annual Meeting (American Association of Clinical Chemistry), in Chicago, Illinois in August and at the ASH Annual Meeting (American Hematology Association) in Orlando, Florida in December.