Product category: Rapid tests - clinical chemistry, Point of care - testing systems
POINT-OF-CARE TEST DEVELOPMENT SERVICES
Support for Total POCT developments, pre-feasibility studies, optimization, verification and validation
Future Diagnostics has over 15 years of experience in quantitative Point-of-Care (POC) test developments on several devices/technologies. For this reason, Future Diagnostics is the obvious choice to assist companies with POC test- and platform developments. You can benefit from our POC knowledge on whole blood, dry-chemistry, nano-technology, and magnetic beads.
Point-of-Care Point-of-Care testing is a fast growing specialty within the in vitro diagnostics market. POC tests decrease turnaround time (TAT) and therefore improves patient care by near-patient testing. You can think about rapid diagnosis at the emergency rooms or operating theaters at hospitals, medical specialist's offices, general practitioner's offices or in the ambulance. No more delays in treatment decision making and at the same time no unnecessary anxiety for patients. Besides efficiency, technologies improve fast on precision, reliability and accuracy. In conclusion, the right POC device can deliver lab-equivalent results within 8 - 30 minutes.
Product category: Point of care - testing systems, Immuno assay systems
IVD IMMUNOASSAY DEVELOPMENT
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.
Product category: Anemia related / Vitamin tests, Diagnostic agents / kits for vitamin determination, Reagents for vitamin determination
TOTAL 25-OH VITAMIN D IMMUNOASSAY DEVELOPMENT
Vitamin D Vitamin D research has expanded greatly over the last 10 years. Annual publications listed in PubMed with the key word 'Vitamin D' increased with more than two-fold from 1675 in 2005 to 3953 in 2014. Part of this increase is due to research showing that Vitamin D deficiency is associated with a wide range of diseases and health outcomes. Until the 1980s, the primary focus of Vitamin D research (in combination with calcium supplementation) was on bone diseases. Since then, observational studies have linked Vitamin D deficiency with increased risk of many diseases: both acute and chronic. The market for Vitamin D is projected to reach about $2.5 Billion by 2020 at a Compound Annual Growth Rate (CAGR) of 11%.*
Adequate level of Vitamin D for human health Vitamin D, the sunshine Vitamin, has received a lot of attention recently as a result of a meteoric rise in the number of publications. They show that Vitamin D plays a crucial role in a plethora of physiological functions. Vitamin D deficiency is associated with many acute and chronic illnesses including disorders of calcium metabolism, autoimmune diseases, some cancers, type 2 diabetes mellitus, cardiovascular disease and infectious diseases.
Vitamin D deficiency is now recognized as a global pandemic. The major cause for Vitamin D deficiency is the lack of appreciation that sun exposure has been and continues to be the major source of Vitamin D for children and adults of all ages. Vitamin D plays a crucial role in the development and maintenance of a healthy skeleton throughout life. There remains some controversy regarding what blood level of 25-hydroxy Vitamin D should be attained for both bone health and reducing risk for Vitamin D deficiency. What is associated with acute and chronic diseases and how much Vitamin D should be supplemented?
25-hydroxy (25-OH) Vitamin D Vitamin D in the circulation is bound to the Vitamin D binding protein. This is transported to the liver where Vitamin D is converted by the Vitamin D-25-hydroxylase to 25-hydroxy Vitamin D [25(OH)D]. This is the major circulating form of Vitamin D that is used by clinicians to measure Vitamin D status. It is biologically inactive and must be converted in the kidneys by the 25-hydroxyl Vitamin D-1Į-hydroxylase (1-OHase) to its biologically active form 1,25-dihydroxy Vitamin D [1,25(OH)2D].
Patent release reagent for Vitamin D Future Diagnostics holds a patent in the field of conducting an immunoassay of 25-OH Vitamin D in blood or blood components, notably serum or plasma. The invention pertains to an immunoassay method, including point-of-care tests. Samples of blood or blood components are tested for total Vitamin D or Vitamin D metabolites, in particular 25-OH Vitamin D using an agent to release Vitamin D from endogenous binding proteins.
Do you miss a Vitamin D immunoassay in your product range? 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
Feel free to contact us and explore the possibility to have your companys name on a total 25-OH Vitamin D.
Sources: 1) http://www.marketsandmarkets.com/PressReleases/Vitamin-d.asp 2) Vitamin D and Human Health by Simon Spedding (ed)
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: