Merck KGaA. (10/13/16). "Press Release: Merck Introduces First Certified Spiking Solution of Heavy Labeled Thyroglobulin Protein". Darmstadt.

	Organisation	Merck KGaA
	Group	Merck (DE) (Group)
	Product	Cerilliant® certified reference materials (CRMs)
	Product 2	LC/MS (liquid chromatography/mass spectrometry)

> First to represent Cerilliant® portfolio in reference standards of endogenous protein biomarkers

> Suitable for critical diagnostic testing applications by liquid chromatography, mass spectrometry

Merck, a leading science and technology company, today introduced the first Certified Spiking Solution® of intact, heavy labeled Thyroglobulin in SigMatrix®, a synthetic surrogate serum. The matrix-based reference material is suitable as an internal standard for the quantification of Tg levels to ensure accurate, identifiable and quantifiable clinical diagnostic testing. Merck’s solution-based product is the first endogenous protein biomarker of the extensive Cerilliant® portfolio.

Measurement of patient Thyroglobulin levels is primarily performed to monitor differentiated thyroid carcinoma recurrence following therapy.1 Quantification of Thyroglobulin levels is also useful in determining the cause of hyperthyroidism and for monitoring treatment effectiveness in Graves disease.1

Anti- Thyroglobulin autoantibody (TgAb) is present in about 25 percent of thyroid cancer patients and can interfere with Tg immunoassays (IA), causing false-negative results.2,3 Quantitative mass spectrometry-based analysis of Thyroglobulin concentrations in serum is the preferred assay for measuring Thyroglobulin in TgAb positive patients.2,3 Recent studies suggest that reflex testing of Thyroglobulin levels by LC-MS/MS method following a positive IA test for TgAb can lead to substantial cost savings as a result of improved test utilization.2

Cerilliant® Certified Spiking Solutions® are manufactured using validated processes to ensure the highest level of accuracy for critical quantitative mass spectrometry-based applications. The portfolio spans from therapeutic drug monitoring, diagnostic testing, clinical chemistry and endocrinology to pharmaceutical research, clinical toxicology, and forensic analysis. Merck offers parent drug, metabolite, endogenous biomarker and internal standard Certified Spiking Solutions® for clinical and diagnostic testing applications- which includes omega-3 and omega-6 fatty acids, bile acids, catecholamines, vitamins, immunosuppressants, cardiac drugs, antiretrovirals and antifungals to hormones including male, female, neonatal, thyroid and hydroxyvitamin D.

References

1. https://labtestsonline.org/understanding/analytes/thyroglobulin/tab/test/
2. http://arup.utah.edu/media/shortTopics/aacc15_straseski/Straseski-AACC2015-Tg%20by%20MSv11.pdf
3. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4016991/

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Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2015, Merck generated sales of € 12.85 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck, Darmstadt, Germany holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

Record changed: 2016-11-01

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Merck KGaA. (10/13/16). "Press Release: Merck Introduces First Certified Spiking Solution of Heavy Labeled Thyroglobulin Protein". Darmstadt.

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