IRIS International, Inc. Submits 510(k) Application To FDA For Its N.A.D.I.A. Prostate Cancer Test

CHATSWORTH, Calif.--(BUSINESS WIRE)--IRIS INTERNATIONAL, INC. (NASDAQ: IRIS) today announced that its Iris Molecular Diagnostics (IMD) subsidiary has filed a 510(k) application with the U.S. Food and Drug Administration (FDA) for its ultra-sensitive Prostate-Specific Antigen (PSA) test. The Nucleic Acid Detection Immuno Assay (NADIA) technology utilized to develop the ultra-sensitive PSA test was compared to a commercially available test and compared well across the assay range with improved sensitivity at low concentrations. NADIA PSA is to be used for monitoring prostate cancer patients following therapy.
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