Qiagen launches Olerup SSP AB’s new test for detecting adverse reactions to HIV-medicine in the EU
LinkMed’s wholly owned subsidiary Olerup SSP AB has developed a new test that detects genetic variations in the Human Leucocyte Antigen (HLA) system that indicate risk for severe adverse reactions to Abacavir in HIV patients. The test is marketed and sold by Qiagen. Experts expect more tests for similar markers in the future.
HIV patients carrying the HLA-B*5701 marker have a 60 percent higher risk to develop hypersensitivity reaction (HSR) to Abacavir, a component of several widely marketed HIV-drugs. HSR is a serious and sometimes fatal multi-organ syndrome.
In July, the U.S. Food and Drug Administration (FDA) advised healthcare professionals that all HIV patients should be screened for this genetic variation before initiating treatment with drugs containing Abacavir. Institutions in other countries such as Germany issued similar warnings. These advisories were issued as a response to results from a new study published in the New England Journal of Medicine earlier this year. The study, carried out on 956 patients from 19 countries, found that HLA-B*5701 is a major biomarker for the HSR.
”The screening for HLA-B*5701 prior to Abacavir treatment allows the identification of patients likely to develop HSR,” says Magnus Ingelman-Sundberg, Professor and Head of the Section of Pharmacogenetics at the Karolinska Institute in Stockholm and responsible for the commentary on the study in the New England Journal of Medicine. ”The combination of diagnostics and therapeutics is a key approach to eliminating risks of side effects and therefore increasing the efficacy of the drugs.”
Dr Ingelman-Sundberg expects more tests for pharmacogenetic markers to be introduced in the near future, including tests for HLA alleles, which are believed to play an important role in patients’ responses to a number of drugs.
The new test is CE marked in Europe for in vitro diagnostic use and available for research use in other countries.
Please visit www.qiagen.com for a more comprehensive press release.
About Olerup SSP AB
Olerup SSP AB is world leading in the development of reagents and kits for genomic HLA typing, which is a required step performed prior to a transplantation operation in order to match the donor and recipient. HLA typing is primarily carried out before bone marrow transplantations (hematopoietic stem cell transplantation) but is also carried out in conjunction with solid organ transplantations (kidneys, lungs, hearts, etc). The better the match between donor and recipient, the lower the risk of transplantation-related complications. Genomic HLA typing is therefore a standard procedure prior to bone marrow transplantations. Olerup SSP AB was acquired by LinkMed AB in July 2008.
For more information:
Ingemar Lagerlöf, CEO LinkMed, tel: +46 8 508 939 93
Also visit www.linkmed.se