Changes in technical documentation for IVD assays. Since May 2017, the In-Vitro Diagnostic Directive (IVDD) is replaced by the new In-Vitro Diagnostic Regulation (IVDR). IVD device manufacturers have a five-year transition period to be fully compliant with all changes as set forth within this new regulation. A significant number of definitions will change, which may […]
A miniature Bio-photonics Companion Diagnostics platform for reliable cancer diagnosis and treatment monitoring. BIOCDx project is an initiative funded by the European Union under the H2020 Programme, aiming to provide a Point-of-Care (PoC) device for early cancer diagnosis and treatment monitoring. Current diagnostic options for cancer treatment monitoring rely on imaging techniques and cannot guarantee […]
Are you a biotech startup or university spin-off company and you want to transform your biomarker or concept assay into a product that is ready for the CE/IVD market or FDA approval? Have you thought about the steps that are required to get to this point? Do you have the experience and/or the resources to […]
Our facility is closed on the following days: Monday December 25th, 2017 Tuesday December 26th, 2017 Monday January 1st, 2018. We will re-open on Wednesday December 27th and on Tuesday, January 2nd 2018. We wish you the best of joy and cheer for Christmas and for the coming year!
Currently, Free T4 (thyroid hormone) measurements are well established in clinical diagnostics. Free T4 measurements, which reflect both total T4 levels and binding protein capacity, have become the recognized standard for determining thyroid status in conjunction with a TSH measurement. Similarly, in several conditions such as pregnancy, renal disease or liver disease the level of Vitamin […]
Future Diagnostics performs pre-feasibility studies for third parties within the global medical technology and IVD market. These pre-feasibility studies are performed on different types of raw materials or assays. It can also be done on a variety of technologies and analyzers, both immunologically or molecular based. Have a look at our presentation on Slideshare
This week we are proud to be celebrating the 20th Anniversary of Future Diagnostics. We take this opportunity to thank all our employees, customers, partners and other stakeholders for their loyalty and helping us succeed.
VALENCIA, SPAIN, March 2017: Zenosense, Inc. (OTCQB: ZENO) (“Zenosense”, the “Company”), a healthcare technology company primarily focused on the development and commercialization of MIDS Cardiac™, a Point of Care (“POC”) handheld device for the early detection of certain cardiac event biomarkers to significantly accelerate the triage, diagnosis, treatment and disposition of patients reporting chest pain […]
“Biological materials have a mind of their own” AroCell’s research and development staff members started a valuable collaboration with Future Diagnostics in the Netherlands in 2011, for the development of the TK 210 ELISA test throughout all these different phases. Collaboration between AroCell team members and this extended contract assay development organization has led to […]
According to IVD companies, the market for near-patient testing is growing significantly. Diagnosis by Point-of-Care testing accelerates patient care decision-making and fast-tracks the time to initiate treatment. Because of the complexity, regulatory guidelines and the complicated set-up of POC platforms the growth potential is limited. Talking to our scientists, I learned about the complex decisions that have to […]