Media Release

08 November 2011

Roche announces commercial availability of the new Elecsys PTH (1–84) assay

Fully automated assay provides accurate assessment of parathyroid function in patients with chronic kidney disease in routine clinical practice

Roche announces the market availability of the Elecsys PTH (1–84) assay in the EMEA/LATAM, Canada, and APAC region. The assay is a unique testing solution for the exclusive detection of full-length parathyroid hormone (PTH) in patients with secondary hyperparathyroidism, a common condition in patients with chronic kidney disease. The new one-step sandwich assay is fully automated and works without using radioactive isotopes.

Chronic kidney disease (CKD) is a serious condition that affects 13% of the world’s population and more than 30% of the elderly.1 Around 80% of patients with advanced CKD will develop secondary hyperparathyroidism,2 which results in increased secretion of PTH by the parathyroid glands in the neck. One of the main roles of PTH is to increase calcium levels in the blood by stimulating the release of calcium from bones. However, an elevated concentration of active full-length PTH (1–84) in blood serum affects the body’s ability to regulate calcium, sodium, phosphorus, and vitamin D in the blood and bones, leading to bone deformities and fractures. Clinicians are also increasingly concerned about calcification of soft tissues and blood vessels, which causes swelling and loss of function, and can lead to death.

As CKD becomes more severe, PTH levels in the blood increase. Measuring these levels is essential to ongoing clinical management in CKD. As well as PTH (1–84), PTH (7–84) – fragments of PTH – accumulates in the bloodstream of patients with severe CKD, particularly those receiving dialysis. Using traditional assays, the presence of PTH (7–84) leads to an overestimation of concentrations of active full-length PTH, further compounded by the longer half-life of these fragments. The Elecsys PTH (1–84) assay from Roche does not detect PTH fragments.3 By exclusively measuring whole PTH, it provides clinicians with a more accurate assessment and, therefore, the potential for improved management of parathyroid function in CKD patients.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism, and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics, and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life, and survival of patients. In 2010, Roche had over 80,000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more

1) Brosnahan, G. et al. (2010). South Med J 2010;103: 140–146
2) Samson, W. et al. (2010). Dialysis & Transplant;39: 92–96
3) Tanaka, H. et al. (2011). Therapeutic Apheresis and Dialysis;15(Supplement 1):56–61