MilliporeSigma Introduces First Certified Spiking Solution® of Heavy Labeled Thyroglobulin Protein
- First to represent Cerilliant® portfolio in reference standards of endogenous protein biomarkers
- Suitable for critical diagnostic testing applications by liquid chromatography, mass spectrometry
Billerica, Massachusetts, October 13, 2016 — MilliporeSigma today introduced the first Certified Spiking Solution® of intact, heavy labeled Thyroglobulin (Tg) in SigMatrix®, a synthetic surrogate serum. The matrix-based reference material is suitable as an internal standard for the quantification of Tg levels by LC-MS/MS methods to ensure accurate, identifiable and quantifiable clinical diagnostic testing. MilliporeSigma’s solution-based product is the first endogenous protein biomarker of the extensive Cerilliant® portfolio.
Measurement of patient Tg levels is primarily performed to monitor differentiated thyroid carcinoma recurrence following therapy.1 Quantification of Tg levels is also useful in determining the cause of hyperthyroidism and for monitoring treatment effectiveness in Graves disease.1
Anti-Tg 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 Tg concentrations in serum is the preferred assay for measuring Tg in TgAb positive patients.2,3 Recent studies suggest that reflex testing of Tg levels by LC-MS/MS 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. MilliporeSigma 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.
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Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, generated sales of € 12.85 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, 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.
Merck KGaA, Darmstadt, Germany, today provided an overview of its innovative pipeline with a focus on five mid- to late-stage assets with first-in-class and/or best-in-class potential at its R&D Update Call.