SeraCare Life Sciences, Milford, Conn, has announced the commercial launch of an expanded neurotrophic tropomyosin receptor kinase (NTRK) RNA fusion reference material panel developed in partnership with Bayer, Leverkusen, Germany.

The Seraseq NTRK FFPE RNA reference material contains 15 clinically significant NTRK RNA fusions across the NTRK1, NTRK2, and NTRK3 genes. It is intended for use by clinical laboratories looking to validate detection of the RNA fusions by next-generation sequencing (NGS). The RNA fusions are present inside SeraCare’s reference cell line GM24385, and are provided in a formalin-fixed, paraffin-embedded format 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 such overexpression, NGS is an ideal platform for identifying tumor biomarkers by looking at many possible gene fusion pairings.

Russell Garlick, PhD, SeraCare Life Sciences.

Russell Garlick, PhD, SeraCare Life Sciences.

Although NTRK gene fusions are important biomarkers, they are not routinely tested for and are not 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. SeraCare’s representative panel of NTRK RNA fusion reference materials will enable labs to develop and validate their ability to reliably detect important fusion genes across NTRK1, NTRK2, and NTRK3.

“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,” says 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 NTRK gene fusions can be treated, high-quality testing via next-generation sequencing is of key importance,” says Svetlana Kobina, MD, PhD, 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.”

For further information, visit SeraCare Life Sciences and Bayer.