FDA APPROVAL FOR IPF MASTER

The Sysmex IPF Master software module for the XE2100 automated haematology analyser has received FDA approval for marketing in the USA.

Launched last summer in Europe, over 75 European customers have already purchased the clinically informative software. IPF Master measures the Immature Platelet Fraction of patient blood samples as an indicator of platelet production in the bone marrow.

Thrombocytopenia is an abnormal haematological condition in which the number of platelets is reduced, and the most common cause of bleeding disorders. Allowing haematology laboratory staff to deliver a more advanced service, the reportable IPF parameter provides diagnostic information which impacts directly on clinical decision-making for the monitoring and treatment of thrombocytopenic patients, and reduces unnecessary invasive procedures.

The XE2100 performs automated sampling of patient peripheral blood, a fixed temperature-controlled incubation with polymethine RNA stain, automated scattergram analysis (ACAS) and gating with a proprietary Sysmex algorithm using the IPF Master software. The immature platelet fraction (IPF%) is expressed as a proportional value of the total platelet count and provides a rapid indication of the platelet production rate.

An increased IPF% is indicative of increased thrombopoiesis (platelet formation) and an active bone marrow. IPF Master can therefore differentiate between decreased production/bone marrow failure and increased platelet consumption in the peripheral circulation as the cause of thrombocytopenia. This critically reduces the need for invasive bone marrow examinations and provides an easy to use rapid test that will allow clinical utility of the immature platelet fraction to be further evaluated in haematological disorders.