ARUP Laboratories & Biomonitor A/S Form Partnership To Monitor MS Patients Using Interferon Therapy
Salt Lake City and Copenhagen, Denmark - ARUP Laboratories and Biomonitor A/S recently 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 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.
SOURCE: ARUP Laboratories and Biomonitor A/S