Vitamin D Assay Development

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 company’s 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)

Have your Company’s Name on a Total 25-OH Vitamin D Assay

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