Clinical Use of XM-ONE in focus at ASHI symposium
The annual ASHI meeting was held in New Orleans, LA, last week and attracted specialists within the field of transplantation immunology. At the meeting Allenex subsidiary AbSorber, together with their US distributor Olerup Inc., hosted a lunch symposium focusing on the clinical use of XM-ONE®, Absorber’s endothelial cross match test. AbSorber is part of Allenex Group.
The title of the symposium was “Improving outcomes in kidney transplantation: Non-HLA antibodies and Enhanced Clinical Risk Assessment”.
The Hopkins Experience of XM-ONE®
Dr Annette Jackson started the symposium by reviewing the experience at her lab at Johns Hopkins University in Baltimore, MD. Johns Hopkins was one of the first laboratories in the world to start using the assay and was also one of six participating centers in the multicenter study published in 2009 (Breimer et al, Transplantation, Feb 27, 2009). Dr Jackson and co-workers has thereafter confirmed the findings in the multicenter study in a single center extension of the same study (Transplantation, 2011 Jul 15). As in the multicenter study they could observe a significantly higher risk of developing acute rejections among the XM-ONE® positive patients. What they also showed was that these rejections were cellular, with absence of complement activation.
The advantages with the XM-ONE®test is that the method is easy, there is a strong correlation between anti endothelial cell antibodies and rejection and that the antibodies detected are donor specific. Dr Jackson is currently working with Stanford University, Stanford, CA with identification of non-HLA antigens via protein array.
Introducing the XM-ONE® Proficiency Testing
In 2008 XM-ONE®was cleared for the US market by FDA and still the assay is the only FDA cleared transplantation cross match. In Europe XM-ONE®is CE marked including CD3 and CD19 enabling a simultaneous T-, B and EC cross match in the same tube. In the US the FDA cleared version is without CD3/CD19.
In September 2011 was the first US external proficiency testing (EPT) performed. The Clinical Laboratory Improvement Act (CLIA) regulations require that all clinical laboratories participate in an external PT program approved by CLIA. The XM-ONE®EPT is approved by ASHI and CLIA. Five US ASHI accredited labs participated in the September EPT and all participating centers were graded satisfactory. The EPT program will run twice yearly with the next EPT being in February 2012. Centers wanting to participate should contact customer support at Olerup, Inc.
Clinical Case Reports
The symposium was ended by case reports from three different centers including Barnes Jewish, Johns Hopkins and Karolinska Hospital. The three cases all describes patient considered to be “safe” to transplant due to negative standard cross matches. Occurrence of severe rejections in such patients are not uncommon and provides a challenge to the attending physician as well as to the immunologist and patologist. XM-ONE®proved to be a valuable tool in firstly diagnosing the cause of the rejection/graft loss both pre- and post transplantation and also to be of value in choosing therapy and/or in allocating the organ.
“We are excited about the very positive interest that XM-ONE® has received in the transplant community around the world. It is especially encouraging to see the clinical utility of the assay being even more defined and that XM-ONE starts to assists the clinical community in decision making in organ transplantation” says, Anders Karlsson, CEO of Allenex.
XM-ONE®
XM-ONE®is a standardized, cell based, cross match test for clinical use. The use of XM-ONE® allows you to identify patients with anti endothelial cell antibodies, a risk factor for acute rejections in organ transplantation. XM-ONE®provides additional information compared to the currently used lymphocyte cross match tests.
For further information, please visit www.absorber.se
For more information please contact:
Anders Karlsson, CEO, tel: +4670-918 0010, email: anders.karlsson@allenex.se
Lars Öqvist, Director Marketing, Absorber AB, tel +46 76276550 email: lars.oqvist@absorber.se
Or visit www.allenex.se
Allenex is a life science company that develops, manufactures, markets and sells high quality products and services that enables for safer transplantations with better results. Allenex is listed on NASDAQ OMX Stockholm Small Cap (ticker: ALNX).