The Swedish biotech company AbSorber recently received FDA approval in the U.S. for its patented transplantation test XM-ONE®. Now AbSorber has received further support for its
transplantation test from a major clinical trial in which six well-reputed transplantation centers in the U.S. and Sweden participated. The results of the study show that XM-ONE® provides valuable information that refines the diagnostics of matching the right organ with the right patient, thereby increasing the probability of a successful transplantation.
Following recent FDA approval, XM-ONE® has received yet another positive breakthrough - this time the results of major clinical trials in which four U.S. and two Swedish well-reputed transplantation centers participated. The study was presented on August 14 at the global transplantation congress in Sydney by Professor Andrea Zachary, a renowned expert in the transplantation area, at John Hopkins University Hospital in Baltimore.
"The study demonstrates and confirms an increased frequency of rejection reactions among patients who test positive with XM-ONE®, even in cases where conventional lymphocyte crossmatch tests are unsuccessful in detecting donor-specific antibodies. Prior to now, we have not
been able to be sure that we could detect these important non-HLA anti-bodies" says Professor Zachary.
"The study shows that we now, with XM-ONE®, easily can get access to donor cells that allow detection of non-HLA anti-bodies. This in turn, improves donor-recipient pairing and kidney transplantation outcome", adds Professor Andrea Zachary.
From June 2005 to October 2006, a total of 195 patients were screened of which 147 patients met inclusion criteria and were therewith evaluated in the XM-ONE® clinical trials. Patients participating in the trials were from the Sahlgrenska University Hospital in Gothenburg, Johns Hopkins University School of Medicine in Baltimore, Ohio State University in Columbus, Massachusetts General Hospital in Boston, Baylor University Medical Center in Dallas and the Karolinska University Hospital in Huddinge.
"The study is a first step in building up a scientific knowledge base about and clinical acceptance of XM-ONE®. The work has awakened great scientific interest and several other transplantation centers want to conduct their own independent trials with XM-ONE®," said associate professor Jan Holgersson, doctor and researcher at the Karolinska University Hospital and founder of AbSorber.
"XM-ONE® provides key, previously unattainable, information about donor/recipient compatibility that increases the probability of a successful transplantation. XM-ONE® opens up completely new possibilities for detecting antibodies that we previously were unable to identify," continued Holgersson.
"Using XM-ONE®, we can now identify the extent of clinical problems related to anti-endothelium cell antibodies in patients undergoing transplantations," said Holgersson.
Jan Holgersson, Karolinska University Hospital, tel: +46 8 585 81384
Anders Karlsson, CEO AbSorber, tel: +46 70 918 00 10
See also www.absorber.se
AbSorber develops products that facilitate more successful transplantations. AbSorber's first product, the transplantation test XM-ONE®, detects key antibodies responsible for post-transplantation rejection reactions. XM-ONE® is already CE marked and FDA approved for sales in the EU and U.S.