– Curetis reiterates that it expects FDA to provide decision on clearance of Unyvero LRT in the second half of 2017
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis“), a developer of next-level molecular diagnostic solutions, today provided an update regarding the ongoing interactive review by the U.S. Food and Drug Administration (FDA) of its 510(k) application for clearance of the Unyvero Platform and Lower Respiratory Tract Infection (LRT) Application Cartridge.
– First quarter 2017 revenue increases 2.6-fold year over year
– Successful completion of CE performance evaluation study and launch of Unyvero IAI Intra-Abdominal Infections (IAI) Cartridge
– Incorporation of wholly-owned subsidiary Ares Genetics to accelerate commercialization of GEAR database
Curetis N.V. (the “Company” and, together with Curetis GmbH, “Curetis”), a developer of next-level molecular diagnostic solutions, today published a business and financial update for the first quarter ended March 31, 2017, and provided details on its outlook for the remainder of the year.
Company News: Updated Results of Cervical Cancer Study Sponsored by ISA Pharmaceuticals to Be Presented at ASCO 2017
– Phase I/II trial shows significant responses of HPV16-positive patients with late-stage cervical cancer
ISA Pharmaceuticals B.V., a clinical-stage immunotherapy company, today announced that an update of the results of a company-sponsored clinical Phase I/II trial in late-stage cervical cancer patients (ISA101-CervISA) will be presented at the 2017 ASCO Annual Meeting (June 2-6, 2017, Chicago, IL, USA).