Ikonisys gets US nod to market automated prenatal diagnostic:
This article was originally published in Clinica
Executive Summary
The US FDA has given Ikonisys clearance to market its automated scanning microscope-based test for prenatal genetic diagnosis. The Ikoniscope fastFISH amnio test system is an in vitro diagnostic for aiding in the detection of the most common chromosomal aneuploidies for chromosomes 21 (Down's syndrome), 18 (Edward syndrome), 13 (Patau syndrome) and for numerical aberrations for sex chromosomes X and Y. The test can provide a result within 24-36 hours. Commenting on the US approval, Ikonisys chairman and CEO Petros Tsipouras said: "It will give us the opportunity to market our first product - to the largest market in the world."