SeraCare Introduces CE Marked ACCURUN® 644 Control for Cystic Fibrosis Diagnostic Testing to the European Market
SeraCare Life Sciences (Nasdaq: SRLS), a global life sciences company providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics, today announced it has received CE marking for its ACCURUN® 644 Control for Cystic Fibrosis Testing, now available in Europe. After serving as a highly effective tool for research purposes in the U.S. for two years, the control is now labeled for in vitro diagnostic use in the European market.
This synthetic, multiplex control is an effective mechanism for identifying mutations in the cystic fibrosis CFTR gene, covering all mutations in the Luminex xTag™ Cystic Fibrosis 39 kit v2 IVD assay. By covering the largest number of mutations in a single vial of any commercial control, the ACCURUN® 644 Control offers labs tremendous advantages in terms of both quality control and cost. Using the multiplex control allows for detection of significant errors missed or more difficult to identify using rotating genomic DNA controls – enabling labs to improve error detection with fewer controls, reducing costs, improving throughput and increasing revenue potential.
“SeraCare’s synthetic control for cystic fibrosis diagnostic testing offers labs the ability to test all 39 separate reactions in one well, enabling much better quality control testing coverage than rotating gDNA schemes,” said Tamara Smith, Senior Manager, Marketing Operations, SeraCare Life Sciences. “Now our European customers will be able to ensure the highest quality, while increasing the efficiency and throughput of their cystic fibrosis diagnostic testing by obtaining improved coverage using fewer wells.”
The ACCURUN® 644 Control can serve as a vital component of a laboratory’s quality control program by improving confidence in the reliability of cystic fibrosis diagnostic testing results. SeraCare provides this control at high purity levels in large lots.
SeraCare’s ACCURUN® 644 Control for Cystic Fibrosis Testing with CE marking is available immediately in Europe. For ordering information, contact SeraCare Customer Service at 1-508- 244-6400 or view the company’s product catalogue at www.seracarecatalogue.com.
About SeraCare Life Sciences, Inc. SeraCare serves the global life sciences industry by providing vital products and services to facilitate the discovery, development and production of human diagnostics and therapeutics. The Company's innovative portfolio includes diagnostic controls, plasma-derived reagents and molecular biomarkers, biobanking and contract research services. SeraCare's quality systems, scientific expertise and state-of-the-art facilities support its customers in meeting the stringent requirements of the highly regulated life sciences industry.