Press Release
| April 16, 2018

Q2 Solutions | EA Genomics expands its Immuno-Oncology biomarker assay portfolio to include Tumor Mutational Burden, Microsatellite Instability and T Cell Receptor Sequencing assays

Morrisville, N.C. – April 16, 2018 – Q2 Solutions | EA Genomics laboratories proudly announces the launch of our Tumor Mutational Burden (TMB) assay, which utilizes whole exome sequencing methodologies coupled with robust bioinformatic tools to deliver an accurate and precise estimate of the overall mutational burden in tumor genome. This portfolio expansion allows us to continue to fuel clinical trial research with our innovative genomic solutions and our commitment to service excellence.

Data presented at the AACR 2018 conference demonstrates that our TMB assay can be applied to a variety of tumor types including those that are traditionally low in the overall mutational burden, such as glioma and renal clear cell carcinoma, and those that are traditionally high, such as lung and melanoma. Our assay yields TMB scores highly compatible to the published scores obtained in the pivotal TMB studies. This new TMB bioinformatics pipeline complements our existing portfolio of industry-leading bioinformatics tools for the analysis of whole exome sequencing data, together allowing for a comprehensive characterization of tumor DNA.

Our TMB assay is one of a series of immuno-oncology biomarker solutions now available at Q2 Solutions| EA Genomics. In addition to our currently available Microsatellite Instability (MSI) assay, we have launched an RNA-based T cell receptor b/g chain NGS clonality assay. Potentiated by the molecular barcodes labelling methodology, this assay enables sensitive, low input, quantitative detection of the T cell receptor clones actively expressed at the RNA level from blood and tumor FFPE specimens. We have also developed immune gene expression signatures which, as reported at the AACR 2018 meeting, are predictive of patient outcomes across many tumor and/or therapy types. Complementary to MSI and TMB, immune gene expression signatures have emerged as important components of the tumor microenvironment reflective of the tumor ability to elicit an immune response. Available at Q2 Solutions| EA Genomics as an output from RNA sequencing or other targeted immune gene expression panel assays, the immune signature scores can be evaluated, in combination with TMB, for association with response to cancer immunotherapies.

Q2 Solutions| EA Genomics supports the entire clinical development continuum, from early discovery through Companion Diagnostic development. Q2 Solutions now offers EA Genomics services in its full-service clinical trial laboratory in Beijing, China.

Download our factsheet to learn more about our TMB assay specifications and our comprehensive portfolio of genomic assays for immuno-oncology applications.

About Q2 Solutions, a Quintiles Quest joint venture
Launched in 2015, Q2 Solutions is a leading global clinical trials laboratory services organization. We help biopharmaceutical, medical device and diagnostics customers improve human health through innovation that transforms science and data into actionable medical insights. Q2 Solutions is a quality driven, responsive partner with strong global experience and deep scientific and medical expertise. The Q2 Solutions joint venture was formed by Quintiles and Quest Diagnostics, combining the best of each parent organizations clinical trials laboratory services capabilities. To learn more, visit www.q2labsolutions.com.