The Obvious Choice for High Quality Diagnostic Solutions.

Future Diagnostics Solutions B.V. is an independent, internationally oriented and certified service provider focused on the medical diagnostics and device industry. Our modern, state-of-the-art laboratory is based in Wijchen, The Netherlands, which is located in the Dutch Health Valley area since 1997.

We are specialized in full IVD immunoassay development, biomarker qualification, point of care test development, and contract manufacturing. Future Diagnostics offers flexible support in feasibility & optimization, verification, technical transfer, and validation. Our expertise is broad and comprises among others the cardiovascular, fertility, infectious, auto-immune, endocrine, metabolism and cancer fields. The FDA-registered facility is fully compliant with all needed regulatory requirements to manufacture IVD products or assays going to market.

Future Diagnostics believes that exceeding customers’ expectations is realized by continuous improvement and applying our core values:

 Integrity, Teamwork, Customer Focus, Organizational Sensitivity 

We have the flexibility to incorporate ideas and technologies from any source to create the best solutions.

Quality

Our approach permits us to guarantee quality control through laboratory analysis and the traceability of our products, which corresponds to regulatory demands. We follow strict procedures based on the ISO 13485, cGMP and FDA standards (inspections in 2004, 2008, 2011, 2016). We get your test designed and manufactured in accordance with IVD requirements and regulations. Your ideas and innovations are safe with us. We are used to work with a Confidential-Disclosure Agreement (CDA) or Non-Disclosure Agreement (NDA) at the start, during and after closure of our projects.

Team

Our dedicated team of 60+ employees has 12 PhD-level scientists on board with profound experience in a wide range of disease areas, technologies, and platforms. We are devoted to manage the diagnostic development and manufacturing process focused on the highest performance standards. Recruitment, training and development of all personnel is important to us to meet the level of expertise needed to meet and exceed customer standards.

STAT-IO-I-PTH

Future Diagnostics also developed, produces, and markets their own CE marked & U.S. FDA cleared product: STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay. This unique system monitors the intact PTH levels during parathyroidectomies. The kit is a two-site chemiluminescent immunometric assay with only one pipetting step and 8-minute turnaround time. The detection antibody is present in the lyophilized accusphere ensuring long stability and low background. Detailed information can be found on www.io-i-pth.com.

Future Diagnostics has a well-established reputation as an independent and reliable partner among the most respected names in the IVD industry. Future Diagnostics works with companies worldwide as an extension of their internal R&D, and with innovative companies that require assay development support to bring new IVD products to market. We are an independent partner for multinationals, mid-sized biotech to small start-up companies. Have a look at an overview of companies we work(ed) with here.


Why work with Future Diagnostics?

We know how important it is for you to quickly reach your target Return On Investment.

We understand that your project does not end after the development.

We put your product on the ‘fast track to market entry’.

Mike Martens

PhD, Managing Director

Ernst Lindhout

PhD, Director Research and Development

Henny Pit

Director Operations