Billerica, Massachusetts, January 13, 2017 — MilliporeSigma, a leading science and technology company, today announced the introduction of its new testosterone calibrator kit for in vitro diagnostic (IVD) use. The certified kit allows users to calibrate assays and verify calibrations, and is the first of its kind to receive CE mark approval, indicating compliance with the European Union's Medical Device Directive. The CE mark allows the kit to be marketed and sold in the European Union and in any country recognizing CE mark approval.
The diagnostic range of the new kit encompasses both male and female testosterone clinical reference ranges. The kit’s broad reference range enables ample analytical sensitivity for accurate testing using new mass spec-based methods, from the lowest levels needed for testing of women and children to the highest levels used in testing of men. The new calibration kit delivers more accurate and consistent test results for more reliable clinical diagnosis and monitoring. Traditional immunoassays used for measuring testosterone levels in patient samples can be inaccurate and deliver inconsistent results, especially at the low levels present in women and children.
The kit is manufactured and tested under the most stringent international quality standards, assuring calibration accuracy. The calibrator kit includes a set of 10 levels of testosterone serum concentration standards ranging from 2-2,000 ng/dL, along with a blank and internal standard.
MilliporeSigma’s portfolio of Cerilliant® certified reference materials are used to validate analytical measurement methods and calibration, and are manufactured and authorized to ensure the highest level of accuracy. Solutions are used in quantitative mass spectrometry-based applications that range from diagnostic testing and endocrinology to therapeutic drug monitoring, forensic analysis, clinical toxicology and pharmaceutical research. MilliporeSigma manufactures a comprehensive list of parent drug, metabolite, endogenous biomarker and internal standard Certified Spiking Solutions® used for clinical diagnostic test applications of steroids and hormones, biogenic amines, hydroxyvitamin D, bile acids, fatty acids, vitamins, immunosuppressants, antifungals and cardiac drugs.
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 some 22,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing, and testing services. Matthias Heinzel is the CEO of MilliporeSigma and a member of the Executive Board of Merck KGaA, Darmstadt, Germany.
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science, and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck KGaA, Darmstadt, Germany generated sales of € 17.5 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics. Since its founding in 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.