SALT LAKE CITY and COPENHAGEN, Denmark, August 10, 2010—ARUP Laboratories and Biomonitor A/S today announced that they have formed an alliance in the monitoring of multiple sclerosis (MS) patients treated with interferon-beta.
“Our relationship with Biomonitor enables ARUP to offer this innovative test to our clients to help manage MS patients,” said Sherrie L. Perkins, MD, PhD, ARUP’s chief medical officer and director of laboratories.”We are very pleased to include this testing as part of our comprehensive menu of services.”
Patient Monitoring
Biotherapeutic drug monitoring is an aspect of personalized medicine in which the individual patient is tested on a regular basis for bioactive drug levels and the possible formation of antibodies that may “neutralize” drug action. Like other biopharmaceuticals, interferon can elicit immune responses, including the production of antibodies. Neutralizing antibodies in MS patients causes a reduction in therapeutic effects of interferon and higher relapse rates. Biopharmaceuticals are expensive and, when they are used to treat chronic diseases, it is important to monitor the patient’s response to the drugs in order to optimize patient care and control disease-related pathologies.
ARUP Laboratories is a leader in personalized medicine in the United States and has significant experience in conventional therapeutic drug monitoring. Several technologies are used, including liquid and gas chromatography, and immunoassays and mass spectrometry to determine post-therapeutic concentrations of circulating drugs and clinically important drug metabolites. ARUP also offers pre-therapeutic evaluation of genetic markers associated with a patient’s potential to metabolize and/or respond to specific drugs.
Biomonitor’s work and research place it among the leaders in Europe in monitoring patients on biotherapeutic drugs using cell-based assays and immunoassays. For the past seven years, Biomonitor has been involved with the Danish Multiple Sclerosis Group and monitored all interferon-beta-treated MS patients in Denmark. The company has also monitored drug levels as well as neutralizing anti-drug antibodies in patients being treated with TNF-alpha antagonists.
iLite™ Technology
The basis of the partnership is Biomonitor’s iLite™. This proprietary technology combines state-of-the-art reporter gene assay methodology with division-arrested, cryopreserved cells, which can respond in a sensitive and reliable manner to report biotherapeutic drug activity in patient serum and can measure levels of neutralizing antibodies. The Biomonitor iLite™ cells are manufactured and tested under the strictest quality standards (ISO 13485 Certification) and has been validated in the ARUP laboratory facilities and will be used with complete confidence to provide accurate and clinically meaningful results.
Dr. Arsalan Kharazmi, CEO of Biomonitor, stated: “We are pleased and enthusiastic about our collaboration with ARUP Laboratories. It allows Biomonitor to take advantage of our many years of experience in monitoring MS patients and to employ our patented iLite™ reporter gene technology in the U.S. market with the help of an outstanding clinical reference lab. We are convinced that biotherapeutic drug monitoring will increase treatment efficacy, save money for the health care systems, and result in excellent patient care.”
ARUP Laboratories has developed and validated the neutralizing antibody test for interferon-beta, and will begin offering the test (test code #2003390) to clients on October 18, 2010.
About Biomonitor
Biomonitor A/S is a privately held Danish company founded in 2003 and among the leaders in developing innovative, reliable assay technologies and incorporating these tests into large and comprehensive patient-monitoring programs. In addition to monitoring programs for MS patients, the company offers laboratory-testing services for patients on anti-TNF drug therapy (both circulating levels of drug and detection of anti-drug antibodies [ADAs]) and, as a specialized CRO, supports the pharma and biotech industry in their drug-development programs for many classes of biological drugs. Biomonitor Limited is Biomonitor A/S’s wholly owned subsidiary located in Galway, Ireland and is an ISO-certified manufacturing facility.
About ARUP LaboratoriesFounded in 1984, ARUP Laboratories is a leading national reference laboratory and an enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients across the United States, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Clinical and Experimental Pathology®.
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Media Contacts:
Biometrics Arsalan Kharazmi +45 39179797(wk), +45 40107500(cell), email ARUP Laboratories Kristofer Beldin Cyndee Holden |