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Biokit reactive to diagnose heparin-induced thrombocytopenia gains FDA approval


Biokit, a company in the Werfen Group that specialises in developing and manufacturing immunoassays and biomaterials and a member of CataloniaBio, has developed the first automatic reactive to diagnose heparin-induced thrombocytopenia (HIT). The reactive, HemosIL HIT-Ab (PF4-H), has been approved by the Food and Drug Administration (FDA) and will soon hit the market in the United States. This is the first authorisation the US agency has granted for a product of these characteristics in the past ten years.

Heparin-induced thrombocytopenia (HIT) is a condition that can occur in some patients when this anti-coagulant triggers a pre-thrombotic state and means treatment must be discontinued. Currently, detecting HIT requires long and complex functional techniques that are prone to giving false positives. With the Biokit HemosIL HIT-Ab (PF4-H) reactive, doctors can do a fully automatic turbidimetric immunoassay and get the results within ten minutes. This is a significant advance in detecting HIT.

For more information, see this press release (Spanish).

Photo: Aerial view of the new Biokit facilities in Lliça de Munt (Barcelona) - © Werfen Group