Quidel Receives CE Mark for Its Point-of-Care Sofia® Quantitative Vitamin D Assay for Use With Sofia Instrument

SAN DIEGO--(BUSINESS WIRE)-- Quidel Corporation (NASDAQ: QDEL), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today it has received CE Mark for its Sofia Quantitative Vitamin D FIA for use with the Sofia fluorescent immunoassay analyzer for the quantitative determination of total 25-OH vitamin D from serum samples. The test is intended for use with the Sofia analyzer to aid in the assessment of Vitamin D sufficiency and is the first quantitative assay on Sofia.

Sofia is the brand name for Quidel’s flagship product, an instrumented immunoassay system. The easy-to-use first-generation Sofia analyzer and its companion assays combine unique software and fluorescent chemistry to yield an automatic, objective result that is readily available on the instrument’s screen, in a hard-copy printout, and in a transmissible electronic form that can network via an LIS system to hospital and medical center databases. The Sofia analyzer along with the Sofia Quantitative D FIA provide reliable diagnostic results within 10 minutes of processing the patient’s serum sample.

Vitamin D is a fat-soluble vitamin that helps maintain serum calcium and phosphate concentrations and plays an important role in bone mineralization. Vitamin D also facilitates cell growth modulation, neuromuscular function, immune function and alleviates inflammation.¹ Consequently, vitamin D deficiency has been correlated with increased risk of various health problems including, but not limited to, cancer, bone disease, cardiovascular diseases, and hypertension.^2,3,4,5 Children ages birth to 18 years with vitamin D deficiency may experience rickets which results in a marked decrease in growth and bone development, including a negative impact on both density and peak bone mass.⁶ During the adolescent puberty years where rapid growth spurts occur, there is a marked increase in the need for vitamin D to maintain the metabolic requirements for growth.⁶

Prevalence of vitamin D inadequacy in humans worldwide is high. Major causes of vitamin D inadequacy include lack of direct exposure of skin to sun without sun protection such as clothing or sunscreen, limited number of foods naturally containing vitamin D, and inadequacy of foods fortified with vitamin D to satisfy vitamin D requirements.^2,3

Total 25-OH vitamin D is the best indicator of vitamin D status. It reflects vitamin D produced cutaneously, obtained from food and supplements,⁷ and has a fairly long circulating half-life of 15 days.⁸ Vitamin D made endogenously in the skin, or obtained from dietary sources, is metabolized to 25-OH vitamin D in the liver. Finally, in the kidneys, it is converted to its biologically active form, 1,25-(OH)₂ vitamin D. In contrast to 25-OH vitamin D, circulating 1,25-(OH)₂ vitamin D is not a good indicator of vitamin D status because it has a short half-life of 15 hours and serum concentrations are closely regulated by parathyroid hormone, calcium, and phosphate.⁸ Levels of 1,25(OH)₂ vitamin D do not typically decrease until vitamin D deficiency is severe.^9,10

“We are pleased to have received approval for our Sofia Vitamin D product and are excited about the opportunity to expand Sofia’s international footprint,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “This also demonstrates our ability to develop quantitative assays on Sofia and Sofia 2 – greatly expanding the potential pipeline and market opportunity for both products.”

CE mark allows Quidel to launch the Vitamin D assay on the Sofia analyzer in Europe and in other locations outside of the United States. The product is currently not for sale in the U.S.

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1. NIH factsheet, http://ods.od.nih.gov/factsheets/VitaminD-HealthProfessional/
2. Holick M.F., Vitamin D deficiency: a worldwide problem with health consequences, Am J Clin Nutr 2008;87(suppl):1080S– 6S.
3. Holick M.F., High Prevalence of Vitamin D Inadequacy and Implications for Health, Mayo Clin Proc., March 2006;81(3):353-373
4. Pilz S, Vitamin D, cardiovascular disease and mortality, Clin Endocrinol (Oxf). 2011 Nov;75(5):575-84.
5. Kienreich K, Vitamin D, arterial hypertension & cerebrovascular disease, Indian J Med Res. 2013 April; 137(4): 669–679.
6. Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM, Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30.
7. Institute of Medicine (IOM), Food and Nutrition Board. Dietary Reference Intakes for Calcium and Vitamin D. Washington, DC: National Academy Press (2011).
8. Jones G. Pharmacokinetics of vitamin D toxicity. Am J Clin Nutr 2008;88:582S-6S.
9. Cranney C, Horsely T, O’Donnell S, Weiler H, Ooi D, Atkinson S, et al. Effectiveness and safety of vitamin D. Evidence Report/Technology Assessment No. 158 prepared by the University of Ottawa Evidence-based Practice Center under Contract No. 290-02.0021. AHRQ Publication No. 07-E013. Rockville, MD: Agency for Healthcare Research and Quality, 2007.
10. Holick MF. Vitamin D deficiency. N Engl J Med 2007;357:266-81.

About Quidel Corporation

Quidel Corporation serves to enhance the health and well-being of people around the globe through the development of diagnostic solutions that can lead to improved patient outcomes and provide economic benefits to the healthcare system. Marketed under the Sofia®, QuickVue®, D3® Direct Detection, Thyretain®, Triage® and InflammaDry® leading brand names, as well as under the new Solana®, AmpliVue® and Lyra® molecular diagnostic brands, Quidel’s products aid in the detection and diagnosis of many critical diseases and conditions, including, among others, influenza, respiratory syncytial virus, Strep A, herpes, pregnancy, thyroid disease and fecal occult blood. Quidel’s recently acquired Triage® system of tests comprises a comprehensive test menu that provides rapid, cost-effective treatment decisions at the point-of-care (POC), offering a diverse immunoassay menu in a variety of tests to provide diagnostic answers for quantitative BNP, CK-MB, d-dimer, myoglobin, troponin I and qualitative TOX Drug Screen. Quidel’s research and development engine is also developing a continuum of diagnostic solutions from advanced immunoassay to molecular diagnostic tests to further improve the quality of healthcare in physicians’ offices and hospital and reference laboratories. For more information about Quidel’s comprehensive product portfolio, visit quidel.com.

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