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Could First-Mover Advantage Make Curetis Ripe For The Picking By Dx Players?

Executive Summary

German molecular diagnostics company Curetis may have missed its original forecast for a 2017 US launch of its flagship Unyvero infectious disease test platform, but CEO Oliver Schacht is confident that the all-clear from FDA is very close. When this crucial milestone is achieved, the firm will be the first in the US with a molecular diagnostic for lower respiratory tract infections. And the approval could increase Curetis' appeal as an acquisition target for larger diagnostics players.

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Device Debut: Curetis' Unyvero Infectious Disease Tester Earns De Novo Clearance

FDA granted de novo clearance to Curetis' Unyvero "sample-to-answer" diagnostic system and the Lower Respiratory Tract Infection Application Cartridge, the company announced April 3. Unyvero works with the Unyvero LRT Application Cartridge to provides rapid infectious disease testing directly from aspirate samples in less than five hours. The FDA decision comes a day after the Singapore Health Sciences Authority approved Curetis' Unyvero BCU Cartridge.

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