With many years of experience in quantitative Point of Care test developments on whole blood, using dry chemistry and short assay times, we are the obvious choice to bring the lab to the patient.
Point of care (POC) testing allows patient diagnosis at the hospital, medical specialist’s office, in the field or ambulance. No more delays in treatment decision making or unnecessary anxiety for patients.
Technologies improve fast on accuracy, precision, reliability and connectivity. Information and data sharing is being made easy so management reporting is no issue. The right POC analyzer can deliver lab-equivalent results.
Product category: Diagnostic agents / kits for vitamin determination
Vitamin D Assay Development Service
Future Diagnostics is your partner when you require an immunoassay to detect total 25-OH Vitamin D. We developed Vitamin D assays on automated immunoassay platforms showing the highest grades of specificity, sensitivity and precision found in the market for large multinational IVD companies.
Three key take-aways in outsourcing the development of your 25-OH Vitamin D assay: 1) Fast to market: feasibility and optimization is already done for you 2) Best specs in the market: highest grades of specificity, sensitivity and precision 3) Success guaranteed: work with an experienced partner
Future Diagnostics develops full IVD immunoassays on demand and offers flexible support in feasibility & optimization, verification & validation projects, and technical transfer to manufacturing for third parties.
Our exploratory phase teams run projects for conjugation, biomarker qualification, benchmarking and bead selection/coating to withstand the golden standard in the market on a daily basis.
The development of an immunoassay involves choosing a format, gathering the right components, and constructing a good working protocol. Optimization of assays takes systematically adjusting and testing all components and variables to ensure results are robust and accurate. The immunoassay formats provide different levels of specificity, sensitivity, simplicity, and speed. They also require different numbers and varieties of components. When we develop an immunoassay from scratch, this is often because the target of interest is a “new” biomarker, in which case a known pair of antibodies may not be available. Searching and matching for the right antibodies may be required.
Future Diagnostics is strongly familiar with various types of immunoassays, such as:
ELISA EIA CLIA Automated Platform based assay Paramagnetic particle based assay Microarray assays Multiplex bead assay Point of care assays Microfluidic assays Enzyme multiplied immunoassay technique (EMIT)Turbidimetric assays
Verification and validation (V&V) are critical phases in the completion of your Design History File. The Design History File is part of the technical file and above all necessary to have your product FDA registered or CE marked. We avoid delay in your product launches, because we know what we are doing. In other words, how frustrated can it be if you misinterpreted the guidelines for any documentation needed. The Food and Drug Administration (FDA) and EU Directive 98/79/EC set the recommendations for all steps in the manufacturing procedures. They have the authority and responsibility to perform inspections and audits in regards to the V&V process which is performed by the manufacturer. Our Quality Control and Assurance follow strict procedures based on the ISO9001 /13485 and FDA standards.
Advantages to involve Future Diagnostics in performing your V&V work: ◾Get your IVD product CE/FDA ready ◾Minimal involvement required from your R&D and QA teams ◾Work with our dedicated, highly experienced teams ◾Confidentiality is guaranteed ◾Compliant with NEN-EN 13612 and CLSI guidelines ◾If desired transferable to our manufacturing ◾Free up your own R&D team to initiate new developments
Future Diagnostics Solutions B.V. is leading in assay development and manufacturing services to the medical diagnostics and device industries. Our international expertise includes a wide array of disease areas and detection technologies. We develop high qualitative in vitro products (IVD) for our multinational customers. Future Diagnostics Solutions provides new and established production capabilities that fulfill the requirement of IVD products.
The well-established reputation as an independent and reliable partner among the most respected names in the IVD industry confirms our vision of integrity, customer service, sensitivity and cooperation. Future Diagnostics Solutions 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. Our R&D team is experienced in all phases of assay development, and will make sure that every new product and project meets the highest performance standards.
Future Diagnostics Solutions integrates its Quality Management System within every assay development project. Based on the ISO-9001/ISO-13485 standards, all of the development and manufacturing work is performed according to written Standard Operating Procedures (SOP's). Routine audits by Lloyd's give our customers the assurance that we maintain their high quality standards.
The production and worldwide distribution of our own developed real time test, STAT Intra-Operative PTH assay, is also part of our activity.