Controls for Warfarin and Thrombophilia Introduced

In August of 2007, the U. S. Food and Drug Administration (FDA; Rockville, MD, USA) approved a relabeling of warfarin that indicates new patients on warfarin should undergo genetic testing prior to long term use of the drug to alleviate dosing regimen problems and reduce adverse events, including significant risk of bleeding.

Two genes seem to have an effect on warfarin sensitivity: CYP2C9 and VKORC1. Developed with human donor genomic DNA, Accurun 601 includes the most relevant alleles for warfarin sensitivity and is the only control kit in this market configured as a single package to control for both CYP2C9 and VKORC1 screening. Single package design will enable molecular testing labs to increase test throughput of patient samples, optimizing instrument capacity.

The genes associated with thrombophilia, cause pregnancy complications, and infertility. Methylenetetrahydrofolate reductase (MTHFR) may represent an important genetic risk factor for thrombophilia. Accurun 610 is a multianalyte control for genetic screening of MTHFR, which includes the most relevant alleles in a single package. Concurrent screening of MTHFR with factor II and factor V screening for thrombophilia offers clinicians a more complete picture of the genetic component of the thrombotic phenotype.

Accurun 601 controls were developed internally by SeraCare Life Sciences (Milford, MA, USA). The company announced that it has entered into an exclusive licensing and technology transfer agreement with Sacred Heart Medical Center & Children's Hospital (Spokane, WA, USA), which allows SeraCare to manufacture and distribute additional controls for genetic testing, including screening for cystic fibrosis and for diseases common among people of Ashkenazi Jewish ancestry, under patents and proprietary knowhow owned by Sacred Heart.

The SeraCare genetic controls business was launched with the introduction of the two new products at the Association for Molecular Pathology annual meeting, held on October 29-November 2, 2008 in Grapevine, Texas (USA).

Related Links:
U.S. Food and Drug Administration
SeraCare Life Sciences
Sacred Heart Medical Center & Children's Hospital