Launch of NGS validated HIV-1 reference materials -- MEDICA - World Forum for Medicine


SeraCare Life Sciences, Inc.

Launch of NGS validated HIV-1 reference materials

SeraCare Life Science, Inc. - Milford, MA USA

Milford, Massachusetts, Sept 23, 2015 – SeraCare Life Sciences, a leading partner to global in vitro diagnostics manufacturers, announced today that the company’s new precision medicine business unit has launched Seraseq™ HIV-1 Reference Materials; a portfolio consisting of 12 individual high-titer HIV-1 viral isolates that have been characterized by next-generation sequencing (NGS). These products are intended for use with targeted NGS assays that determine HIV-1 subtype, identify drug resistance mutations or assign viral tropism.

HIV drug resistance has tremendous consequences in terms of treatment failure and overall health care costs. With increasing numbers of drug resistance mutations being characterized, Sanger sequencing-based assays have been the preferred genotyping method. However, it has been recognized that they are limited in their ability to detect critical minority variants below 20% frequency. As clinical laboratories access to NGS technology increases, so will the ability to develop assays with improved sensitivity. Reference materials with clinically actionable resistance mutations that have been characterized by NGS-methods are critical for labs developing NGS-based assays for HIV. Seraseq™ HIV-1 Reference Materials are high-titer isolates that can be used to validate new assays, compare different test results as well as monitor assay performance on an ongoing basis.

“SeraCare’s longstanding history of producing high-quality, characterized and cultured viruses for HIV (AccuType™ viral isolates) and other infectious disease areas has enabled us to develop a product family optimized for sequencing-based assays”, says Russell Garlick, Chief Scientific Officer at SeraCare. “It is critical that entire regions of the HIV genome be sequenced with high sensitivity to monitor drug sensitivity.” Through our participation in the NGS Proficiency Panel Project sponsored by the Forum for Collaborative HIV Research, we have been able to validate and characterize these 12 HIV-1 isolates across several platforms and laboratories and demonstrate their utility as reference materials for sequencing-based assays.

These products are additional examples of SeraCare’s commitment to supporting the emerging area of precision medicine, consistent with the company’s recent announcements regarding the cultivation of new products and talent, as well as strategic partnerships.

“For over 30 years, SeraCare has provided market leading products for infectious disease, and we are continuing our investment with the launch of Seraseq™ HIV-1 Reference Materials for the sequencing market; the first of many products in development”, says Charlie Mamrak, CEO, SeraCare Life Sciences. “Precision diagnostics will undoubtedly drive the future growth of the industry and we are fully dedicated to creating solutions through technology developments and strategic partnerships to meet the needs of the industry.”

About SeraCare Life Sciences, Inc.
SeraCare enables the promise of precision medicine by advancing the understanding of disease and providing assurance of the diagnostic result. Our innovative tools and technologies not only ensure the safe, effective, and accurate performance of diagnostic assays but also establish a framework for regulating, compiling, and interpreting data from precision diagnostics. Our portfolio includes a broad range of products such as quality control technologies, disease-state specimens and tissues for research and development, processed biological materials, and immunoassay reagents. For more information, please visit and follow SeraCare on Twitter (@SeraCare).