SeraCare Announces Launch of Expanded NTRK Reference Material Panel

An important new tool for labs seeking to detect NTRK gene fusions by next-generation sequencing.

MILFORD, Mass., October 22, 2018 /PRNewswire/ -- SeraCare Life Sciences, a manufacturer and leading partner to global in vitro diagnostics manufacturers and clinical laboratories, announced today the commercial launch of an expanded neurotrophic tropomyosin receptor kinase (NTRK) RNA fusion reference material panel developed in a partnership with Bayer. The Seraseq™ NTRK FFPE RNA reference material contains 15 clinically significant NTRK RNA fusions across NTRK1, NTRK2, and NTRK3 genes and are to be used by clinical laboratories looking to validate their detection by next-generation sequencing (NGS) methods. The RNA fusions are present inside our reference cell line GM24385 and formalin-fixed and paraffin embedded to represent typical processed tumor sections.

TRK Fusion proteins are a primary oncogenic driver across multiple tumors in adults and children. In TRK fusion cancer, the NTRK gene fuses with an unrelated gene causing overexpression of the TRK protein and uncontrolled cell growth. Because many different fusions can cause this overexpression, NGS is an ideal platform to look for these important tumor biomarkers by looking at many possible gene fusion pairings.

To date, while NTRK gene fusions are important biomarkers, they are not routinely tested for and not always included on all testing platforms. Another challenge for labs looking to detect NTRK gene fusions with their NGS tests is the scarcity of characterized clinical samples for the various fusion genes. This representative panel of NTRK RNA Fusion reference materials designed together with scientists at Bayer will enable labs to develop and validate the ability to reliably detect some of these important fusion genes across NTRK 1, 2, and 3.

“We are excited that our innovative Seraseq reference material technology could be used to develop these NTRK RNA fusion genes to enable labs around the world to validate these important biomarkers to their testing panel,” Russell Garlick, Chief Scientific Officer at SeraCare Life Sciences. “More critically, because of the precise manufacture and large-scale availability of this material, it will allow labs to help standardize the measurement of these NTRK fusions from sample preparation through sequencing and bioinformatic assessment.”

“In order that patients with locally advanced or metastatic solid tumors harboring a NTRK gene fusions can be treated, high quality testing via next-generation sequencing is of key importance,” said Dr. Svetlana Kobina, Head of Medical Affairs Oncology at Bayer. “This tool will provide NGS testing providers and proficiency testing organizations more options to help add and improve their ability to detect this important cancer biomarker. Bayer is pleased to be working with SeraCare Life Sciences on this novel reference material.”

Learn more about the Seraseq NTRK FFPE RNA reference material here.

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 provide assurance of 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 www.seracare.com and follow SeraCare on Twitter (@SeraCare).

Company Contact:
Heather DelCarpini
SeraCare Life Sciences, Inc.
508.244.6429
hdelcarpini@seracare.com
www.seracare.com