IGEN gets green light from FDA

IGEN gets green light from FDA

Gaithersburg, MD–IGEN, Inc. has received FDA clearance for its Origen Analyzer and a line of reagents. IGEN develops, manufactures and markets diagnostic systems. This approval represents the first IGEN product to receive FDA market clearance and it is the second product using IGEN`s Origen technology. Origen technology is based on a principle of electrochemiluminescence which utilizes labels that, when attached to a biological substance and then electrochemically stimulated, emit light particles at a particular wavelength. The light emission can then be measured with a high degree of accuracy to detect and quantify a variety of substances such as hormones, bacteria, viruses and cancer.

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