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!
Speaker
Dr. Abdel Halim, PharmD, PhD, CEO/CSO, Wren Laboratories
Dr. Abdel Halim, a Fulbright Scholar, is an executive and internationally recognized KOL with over three decades of experience in biomarker and precision medicine. Dr. Halim is one of only four lab professionals in the US who are triple board-certified in molecular diagnostics, clinical chemistry and toxicology. He is one of only two worldwide accredited by the FDA as a third-party reviewer of the largest list of IVD 510K submissions.
Dr. Halim has led the biomarkers, translational research and precision medicine aspects in 150+ Phase I-Phase III clinical trials in oncology and other indications. He has led 12 end-to-end registrable CDx programs and implemented LDT-based patient selection in 30+ Phase I-Phase II trials. He has overseen the development and validation of hundreds of assays and has championed two drug and several medical device approvals.
Dr. Halim holds a PharmD, two master’s degrees and a PhD in Cancer Molecular Biology. He has published 75+ articles, three book chapters and a single-author reference book.
Message PresenterWho Should Attend?
This webinar will appeal to professionals in the following fields or those with the following job titles:
- Early discovery
- Translational medicine
- Biomarkers
- Precision medicine and companion diagnostic departments
- Clinical study monitors
- Oncology/Cancer research
What You Will Learn
Attendees will learn about:
- With the unparalleled analytical and clinical performance, Wren’s novel multigene mRNA expression technology will make a difference in drug development
- How our approach covers the full scope of biomarkers and precision medicine from early discovery to patient selection/stratification
- How our proprietary RNA stabilization tube significantly outperforms others and makes logistics easy
Xtalks Partner
Wren Laboratories
Wren is at the forefront of transforming cancer diagnostics through advanced mRNA technologies. Our pioneering machine learning-based liquid biopsy tests utilize multiplex mRNA expression to revolutionize cancer patient care and enhance clinical trials. Conducted in a CLIA-certified, CAP-accredited, and NYSDOH-licensed laboratory, our tests are governed by a robust quality management system.
Our NETest® and PROSTest® assays are clinically validated as diagnostic and prognostic tools, for detecting minimal residual disease and recurrence, and for predicting responses to radiotherapeutics in neuroendocrine and prostate cancers. These clinical assays, featuring binary readouts, are suited for patient selection and stratification in clinical trials, serving as companion or complementary diagnostics. Their utility extends beyond oncology: the FDA has recently accepted our NETest® for predicting tumorigenesis in a diabetic drug trial, addressing potential pancreatic neuroendocrine differentiation.
Wren’s innovative pipeline includes assays for colorectal, lung, breast, pancreatic, melanoma, and multiple myeloma cancers. Our theranostic applications offer customized multigene mRNA gene signatures for biomarker and target discovery, POC, POM, or pharmacodynamics.
Led by a team of biopharma experts with unparalleled scientific, clinical, operational, and regulatory experience, Wren is dedicated to delivering best-in-class services where every sample counts.
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