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Asuragen’s Signature NPM1 Mutations Test, Qiagen’s HLA-B*5701 Test

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Asuragen this week launched the Signature NPM1 Mutations Test for research use. The RT-PCR-based assay detects mutations A, B, and D in exon 12 of the nucleophosmin (NPM1) gene from cell line, whole blood, and bone marrow specimens.
 
According to Asuragen, it is one of two exclusive licensees to NPM1, a gene commonly mutated in patients in the early stages of acute myeloid leukemia.
 
“The discovery of the importance of the NPM1 gene also represents a rational approach for the development of molecularly targeted therapies making NPM1 mutation detection potentially useful in drug development research,” Asuragen said in a statement. 
 
Approximately half of all AML patients are thought to be NPM1 mutation positive. 
 
The assay operates on Luminex’s 100 IS or 200 System utilizing a liquid bead array method.
 

 
Qiagen announced this week that it has introduced in the European Union a new molecular diagnostic test to gauge HIV patients with the HLA-B*5701 allele, a genetic variation in the Human Leucocyte Antigen system.
 
According to Qiagen, HIV patients with the HLA-B*5701 marker have a 60 percent greater risk of developing a serious and sometimes fatal multiorgan syndrome, called hypersensitivity reactions, to GSK’s Abacavir. HSR manifests in fever, and respiratory or constitutional symptoms.
 
In July, the US Food and Drug Administration updated Abacavir’s label to recommend that all HIV patients be screened for HLA-B*5701 before initiating treatment with the drug. Addtionally, the 1,956-patient PREDICT1-1-Study published in the New England Journal of Medicine earlier this year identified HLA-B*5701 as a major biomarker for the HSR.
 
Following the FDA’s regulatory action, Germany issued similar recommendations.
 
The HHS Panel on Antiretroviral Guidelines for Adults and Adolescents in January updated its guidelines to change Abacavir’s status as an “alternative” medication to the “preferred” treatment in patients who have tested negative for HLA-B*5701.
 
“HLA-B*5701 testing should be performed prior to initiation of abacavir,” the working group said.
 
In the US, an HLA-B*5701 test is marketed by the Laboratory Corporation of America.

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