MilliporeSigma Expands Portfolio of Certified Reference Materials for Applied Diagnostics and Testing

• Two new products support the identification of the industry-standard alcohol biomarker with high sensitivity
• Seven new products ensure accurate identification of omega-3 and omega-6 fatty acids for diagnostic testing

Billerica, Massachusetts, August 3, 2016 — MilliporeSigma today announced the expansion of its portfolio of Cerilliant® certified reference materials (CRMs) with nine new Certified Spiking Solutions® used in laboratories around the world. The pre-made stock solutions can be spiked into matrices to create accurate controls and calibrators for applied diagnostics and testing, ensuring reliability in the identification and quantification of drugs and endogenous biomarkers.

“Our portfolio of certified reference materials leverages the latest research and techniques from around the world to meet the ever-changing needs of the health care industry,” said Theresa S. Creasey, Head of Strategy, Marketing and Innovation at MilliporeSigma. “MilliporeSigma’s commitment to highly accurate and reliable starting materials helps our customers stay ahead of the curve, ultimately supporting the best possible care and outcomes for patients.”

The new additions to the Cerilliant® product line include two Certified Spiking Solutions® of phosphatidylethanol (PEth), an alcohol biomarker with high sensitivity appropriate for determining moderate to heavy alcohol consumption.1 Due to its superior sensitivity and specificity, PEth is now widely used to detect recent drinking. To date, a false positive blood PEth test result has yet to be reported.2

Seven new Certified Spiking Solutions® of five Omega-3 fatty acids and two Omega-6 fatty acids have also been added to the product line. These fatty acids, the most commonly monitored in clinical and diagnostic testing applications, play a critical role in conditions including coronary heart disease, diabetes mellitus and cancer.3,4 Fatty acid levels are evaluated using mass spectrometry to determine patients’ risk of coronary events, to diagnose essential fatty acid deficiency or to monitor patient response with  therapies or dietary supplements.3,4

Cerilliant® certified reference solutions are manufactured and authorized to ensure the highest level of accuracy. Solutions are used in quantitative mass spectrometry-based applications that range from therapeutic drug monitoring to diagnostic testing and from endocrinology to pharmaceutical research, clinical toxicology and forensic analysis. MilliporeSigma manufactures a comprehensive list of parent drug, metabolite and internal standard Certified Spiking Solutions® used for clinical diagnostic test applications of immunosuppressants, bile acids, vitamins, steroids and hormones, catecholamines, cardiac drugs, antidepressants and pain management drugs.

References

1. http://store.samhsa.gov/shin/content/SMA12-4686/SMA12-4686.pdf
2. http://www.sciencedirect.com/science/book/9780128003398
3. http://www.mayomedicallaboratories.com/test-catalog/Clinical+and+Interpretive/82426
4. http://www.questdiagnostics.com/testcenter/testguide.action?dc=TS_Omega_3_6

About the Life Science Business of Merck KGaA, Darmstadt, Germany
The life science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 19,000 employees and 65 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. Udit Batra is the global chief executive officer of MilliporeSigma.

Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.

Merck KGaA of Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has six businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Biosimilars, Life Science and Performance Materials – and generated sales of € 12.85 billion in 2015. Around 50,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges.

Merck KGaA, Darmstadt, Germany is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. Merck KGaA, Darmstadt, Germany holds the global rights to the name and the trademark “Merck” internationally except for the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD performance materials.