2024 - Novel Liquid Biopsy ML multigene mRNA Expression for Clinical Trials: from Discovery to CDx Development

Liquid biopsy is becoming an attractive matrix to develop non-invasive in-vitro diagnostics for standard patient care and pharmaceutical trials but multigene mRNA expression has been relatively sidelined. Empowered by 115+ patents, 60+ clinical studies conducted in collaboration with 70 investigators and KOLs from the world top 45 institutions in 16 countries, Wren has developed and validated multigene mRNA expression assays.
The PCR data are fed into proprietary algorithms to produce binary readouts as “detected” or “not detected” based on clinically validated cutoffs. We also report the exact score on a scale of 0-100 which helps in monitoring patients’ post-surgery and/or after therapeutic dosing. In addition to assays being validated for multiple solid and hematological tumor indications, our lead NETest® and PROSTest® for neuroendocrine tumors (NETs) and prostate cancer are being offered to patients and biopharma companies in our CLIA, CAP and NYS-licensed laboratories.
Different from others, we only need 1 mL of sample to capture the full cancer image and eliminate pre-analytical hurdles isolating different blood components. To enable this, we innovated our blood collection tubes which can maintain RNA integrity in whole blood for up to 10 days at ambient temperature.
With our leadership team with 100+ cumulative years of experience in oncology biomarkers, translational research, precision medicine and CDx, we are committed to deliver best-in-class services to biopharma companies right from discovery to CDx development and registration. Our offerings include the following:
Ready-to-use CLIA, CAP and NYS-approved blood mRNA assays: NETest® for neuroendocrine (NET) tumor and PROSTest® for prostate cancer
RUO whole blood and saliva assays for lung, pancreas, colorectal, breast, melanoma and multiple myeloma, and RUO saliva assays for NET and prostate cancer
400+ validated cancer-associated genes for a client to pick and choose from
Any mRNA gene panel requested by a client in whole blood or saliva with gene mapping, clustering and signaling analyses
In this presentation, we will walk you through our technology and demonstrate how we could be a solution to biopharma technical, operational and regulatory pain points. We will unveil the key analytical and clinical performance characteristics of our assays and demonstrate their clinical validity for different applications as diagnostic and prognostic biomarkers for patient monitoring to detect MRD or recurrence and to predict response to therapeutics.
In addition to these applications, we will show how our novel approach can help in biomarker and target discoveries and serve as tools for exploratory purposes, including POC, POM and PD. We will also show how our novel blood collection tube outperforms all major brands on the market.
Don’t miss this opportunity to explore the future of biomarkers and precision medicine with us!
Keywords: Biopsy, Precision Medicine, Clinical Research, Oncology, Biomarkers, Liquid Biopsy, CDx, Diagnostics, Therapeutic Areas, Laboratory Technology, Liquid Biopsy Cancer, Basic Research