EU clears Abbott's blood test for ovarian cancer

01/16/2010 | Clinica (subscription required)

Abbott Laboratories has received EU's CE Mark approval for Architect HE4, a blood test designed to help determine whether pelvic masses are benign or cancerous. The company says its product, co-developed with Fujirebio Diagnostics, is the world's first automated HE4 diagnostic. Abbott also filed an application with the FDA seeking 510(k) clearance for the test.

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