CDx Service

Early inclusion of Companion Diagnostics (CDx) is key to successful regulatory approval.

A companion diagnostic is a biomarker that is used as a companion to a therapeutic drug, in order to determine its applicability to a specific person.

Companion diagnostics are ideally co-developed with drugs, to aid in selecting or excluding patient groups for treatment and increase the chances of rapid and successful regulatory approval.

 

 

CDx Examples

The team at Geneseq Biosciences have extensive experience in all areas of companion diagnostic design and execution. These are examples of predictive genomic signatures developed for lung cancer, melanoma and breast cancer.

 

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The Melaseq signature was identified from the ~800 microRNAs present in the Nanostring Human MicroRNA V3 Panel

Melaseq & Nanostring

Melaseq™ is Geneseq Biosciences first liquid biopsy genomic assay. This test is designed to improve the diagnostic accuracy and post-treatment monitoring of cutaneous melanoma.

The was developed using NanoString’s Human v3 miRNA Expression panel, which contains 799 probes that represent >95% of all high-confidence human miRBase reads plus additional clinically-significant microRNAs identified in the literature.

This platform is ideal for discovering new biomarkers of treatment response and translating them into clinical practice.

Let’s talk!

 

Contact us to discuss how Geneseq Biosciences can assist in designing a CDx strategy for your program.

 


References:

  1. Van Laar R, Lincoln M, Van Laar B: Development and validation of a plasma-based melanoma biomarker suitable for clinical use. Br J Cancer 2018.
  2. Van Laar RK: Genomic signatures for predicting survival and adjuvant chemotherapy benefit in patients with non-small-cell lung cancer. BMC Med Genomics 2012, 5:30.
  3. Van Laar RK: Design and multiseries validation of a web-based gene expression assay for predicting breast cancer recurrence and patient survival. J Mol Diagn 2011, 13(3):297-304.