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FDA clears anti-cardiolipin screening test:

This article was originally published in Clinica

Executive Summary

Hycor Biomedical has received FDA clearance to market its anti-cardiolipin autoimmune screening test in the US. The ELISA-based test can be used to detect antibodies associated with antiphospholipid syndrome, a condition that can lead to venous and arterial thrombosis or frequent pregnancy loss. If the screen is positive, reflex testing can be done for anti-cardiolipin IgG and IgM using the Garden Grove, California-based company's previously cleared autoimmune kits.

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