Qiagen has unveiled a diagnostic assay to detect genetic variation causing adverse reactions in AIDS patients.
The company introduced a molecular diagnostic test to type the HLA-B*5701 allele, a genetic variation in the Human Leucocyte Antigen (HLA) system.
HIV patients carrying the HLA-B*5701 marker have a 60 per cent higher risk of developing hypersensitivity reaction (HSR) to Abacavir, which is a component of several widely marketed drugs inhibiting the reverse transcriptase of the HI virus.
HSR is a serious and sometimes even fatal multi-organ syndrome that manifests in fever, respiratory or constitutional symptoms.
On 24 July, the US Food and Drug Administration (FDA) advised healthcare professionals that all HIV patients should be screened for HLA-B*5701 before initiating treatment with drugs containing Abacavir.
Institutions in other countries issued similar warnings.
The regulatory bodies responded to results from a study published in the 'New England Journal of Medicine' earlier this year.
The PREDICT1-1-Study carried out at the Royal Perth Hospital and Murdoch University, Perth, Australia, among 1,956 patients from 19 countries, found that HLA-B*5701 is a major biomarker for the HSR.
Dr Magnus Ingelman-Sundberg, professor and head of the section of pharmacogenetics at the Karolinska Institute in Stockholm, and responsible for the commentary on the PREDICT1-study in the 'New England Journal of Medicine', said: 'The screening for HLA-B*5701 prior to Abacavir treatment allows the identification of patients likely to develop HSR.
'Using HLA-B*5701 tests as a companion diagnostic with the drug Abacavir therefore helps to better protect HIV-infected patients in treatment from severe additional suffering.
'The combination of diagnostics and therapeutics is a key approach to eliminating risks of side effects and therefore increasing the efficacy of drugs.' Ingelman-Sundberg expected 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.
He added: 'Carbamazepine, for instance, which is prescribed for treatment of epilepsy, is more likely to cause dangerous or even fatal skin reaction in Asian patients carrying the HLA-B*1502 allele.' Peer Schatz, chief executive officer of Qiagen, said: 'Our test is another example of the advent of molecular diagnostic tests, which can be used to assess the efficacy of drugs.
'This trend holds great promises for the future.
'Enabling doctors to customise therapies based on molecular tests which create molecular profiles of patients or diseases ultimately leads to more medical innovation, cost-efficiency and - most importantly - to better and safer treatment of patients.'