New assay launches give Roche the most comprehensive immunosuppressive drug monitoring portfolio

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Additional tests support long-term routine management of organ transplant recipients and enhance the testing workflow in medical laboratories

Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the market availability* of the new Elecsys® Sirolimus and Everolimus immunosuppressive drug assays. The launch of these two assays, which complement the currently available mycophenolic acid (MPA), Elecsys Tacrolimus and Cyclosporine assays, completes the Roche Diagnostics immunosuppressive drug monitoring portfolio.

The Elecsys Immunosuppressive drug (ISD) assays offer high precision and consistent results, which are vital factors in helping physicians to correctly tailor immunosuppressive therapy to individual organ transplant patients.  

“Immunosuppressive drug monitoring requires a high level of precision to ensure that patients receive the optimal therapy. The new Elecsys ISD Assays will offer reliable, life-long testing to patients who have had organ transplants,” said Jean-Claude Gottraux, Head of Roche Professional Diagnostics. “This full offering also provides clinical laboratories with the opportunity to optimize their workflows and consolidate testing for a wide range of relevant markers on a single platform. This is a further example of the Roche commitment to invest in personalized healthcare”.

Immunosuppressants must be taken continuously by recipients of organ transplants to prevent transplant rejection. If the dose of the medication is too low it may lead to organ rejection, while excessive doses can cause severe side effects. Therefore, it is important to monitor their concentrations in patients’ blood precisely.

With the Elecsys ISD assays, the required pretreatment step can be done with only a single procedure and reagent, which brings a clear benefit in terms of testing efficiency and reduction of handling errors.

About Elecsys Immunosuppressive Drug (ISD) Assays

More than 100’000 solid organs are transplanted each year1. The success of modern transplantation owes much to the application of highly potent immunosuppressive drugs. Worldwide, Tacrolimus, Cyclosporine,

Sirolimus, Everolimus and MPA are the main immunosuppressive drugs for the long-term maintenance therapy of transplant recipients, in cases where therapeutic drug monitoring is recommended. To deliver this, hospitals require quick turnaround times, reproducible results, flexible throughputs depending on the testing demand, and the diagnostic solution must also be cost effective.

All Elecsys ISD Assays offer performance based on Roche’s proven Elecsys electrochemiluminescence (ECL) technology. The tests can be performed on any of the cobas modular platforms, including the cobas 4000 and cobas 6000 analyzer series, or the high-volume cobas 8000 modular analyzer series. This allows laboratories to consolidate a wide range of assays on a single analytical platform and increase their efficiency. Roche offers a number of additional diagnostic assays on the cobas platforms which are important in the field of transplantation. Fully automated laboratories can also benefit from Roche’s pre- and post- analytical solutions. 

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, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche’s personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-nine medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.

In 2014, the Roche Group employed 88,500 people worldwide, invested 8.9 billion Swiss francs in R&D and posted sales of 47.5 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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*CE-mark; local product availability may vary independently from CE Mark approval.

References:

1.        http://www.irodat.org/