Sign In

Search Press
Looking for press releases of a particular company? Enter company name (or keyword) here.


Lophius Biosciences Completes Necessary Regulatory Milestones with EN ISO 13485 Certification ...

Lophius Biosciences Completes Necessary Regulatory Milestones with EN ISO 13485 Certification and CE Marking for Both In Vitro Diagnostic T-Track® CMV/EBV Test Systems

Regensburg, Germany, May 31, 2012 / B3C newswire / - Lophius Biosciences, a leader in the field of novel T-cell based diagnostic test systems, today announced the successful realization of two important regulatory milestones. With the successful completion of the EN ISO 13485 certification, the company established all prerequisites for a quality management system to meet customer and regulatory requirements applicable to medical devices according to the European IVD guidelines.

In addition, the company announced that it has received CE-marking for its T-Track® CMV and T-Track® EBV tests following successful clinical validation of both products by measuring functional effector cells of the cell-mediated immune system (CMI) in a cohort of > 120 hemodialysis patients. Observed clinical sensitivities in this patient cohort were 88-100% for T-Track® CMV and 86-97% for T-Track® EBV respectively, depending on the biostatistical method applied.

„We are very pleased with the successful completion of these important regulatory milestones which round up our development programs for both tests T-Track® CMV and T-Track® EBV. We now have the tools in place to establish full clinical benefits of these novel T-cell based diagnostics in the field of transplantation and other indications with high medical need” said Dr. Michael Lutz, CEO of Lophius Biosciences.

Link to the press release

Tweet this press release (URL will be shortened by Twitter)

About Lophius Biosciences
Lophius Biosciences GmbH develops and markets innovative T-cell based testing systems for diagnostics and possible therapy control in the fields of transplantation, infection and autoimmune diseases.

Lophius Biosciences GmbH
Josef-Engert-Str. 13
D-93053 Regensburg / Germany
Phone: +49 941 6309 1972

Publisher Contact Information:

Lophius Biosciences
+49 941 6309 1972

Company profile of Lophius Biosciences
Past press releases of Lophius Biosciences.


Tech investments
From our Online Data Service
VC-backed companies
From our Radar

Recent Deals

Nov 25€24.0MInternet commerce
Jul 23€23.0MArtificial Intelligence
Jul 22€20.0MKnowledge management
Jul 5€110.0MOther Biotechnology & Healthcare
Jul 5€13.0MInternet services
Jul 3€3.7MMedical devices
Jul 3€27.0MPayment software

For information on Europe's most extensive database on technology funding click here!


Press Releases

May 28
identiq raises $5m seed, launches privacy-first identity validation...

Apr 29
nethone raised over $1 million from innovation nest

Mar 31
the fit allocates chf 100'000 to comppair technologies

Jan 29
yumpingo raises $10m to transform guest experiences in restaurants

Oct 1
The Link App
the link app launches version 2.0

About usContact usLegal Information
Copyright © 1999-2019
Emerging Technology Research Europe Inc. All rights reserved.