A Medical Device Daily

SeraCare Life Sciences (Milford, Massachusetts) says it has launched its genetic controls business with the introduction of two new products at the Association for Molecular Pathology (AMP; Bethesda, Maryland) annual meeting in Grapevine, Texas.

Initial products launched include Accurun 601 controls for diagnostic testing of warfarin sensitivity and Accurun 610 controls for thrombophilia testing, which were developed internally by SeraCare. Additionally, the company reported an exclusive licensing and technology transfer agreement with Sacred Heart Medical Center & Children's Hospital (Spokane, Washington), 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 know-how owned by Sacred Heart.

"SeraCare intends to build a thriving genetic controls business line offering differentiated genetic controls that make our customers' jobs easier and more productive. We will apply the same in-house expertise, quality systems and state-of-the-art manufacturing facilities that are driving double-digit growth in our molecular controls business to our new genetic controls franchise," said President/CEO Susan Vogt. "In the coming months, we will continue to make key additions to the genetic controls product portfolio as this business line plays an important role in the company's near-term growth strategy and future profitability."

Warfarin is the most widely prescribed oral anticoagulant for thrombosis, stroke and other clotting disorders.

Last year the FDA approved a re-labeling 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, according to SeraCare. Single-package design will enable molecular testing labs to increase test throughput of patient samples, optimizing instrument capacity, the company said.

The genes associated with thrombophilia have been shown to cause pregnancy complications and infertility. Methylenetetrahydrofolate reductase (MTHFR) may represent an important genetic risk factor for thrombophilia, SeraCare noted. Accurun 610 is a multi-analyte control for genetic screening of MTHFR that includes the most relevant alleles in a single package, according to the company. 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, SeraCare says. By using Accurun 610 multi-analyte controls, labs can increase test throughput of patient samples, optimizing instrument capacity, the company said.

SeraCare provides products and services intended to facilitate the discovery, development and production of human diagnostics and therapeutics. The company's portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking and contract research services.