Biopharma Partnerships
Advancing novel cancer therapeutics through next generation liquid biopsy solutions.
Our Pharma Partnership Makes It Possible
We help our pharma partners accelerate precision oncology across cancer indications and therapeutic modalities with research to clinical trials and ultimately, registration and commercial launch.
Our team brings together biopharma and companion diagnostics expertise with biomarker, drug-diagnostic co-development, and commercialization experience.
Our pharma partnerships deliver cancer detection, classification, and quantification results with the potential to analyze and monitor epigenetic signatures from early to advanced stage cancer.
Data from GRAIL studies have demonstrated analytically validated performance1 with robust analytical sensitivity, specificity, and precision.
We leverage the combination of GRAIL’s proprietary methylation-based multi-cancer early detection (MCED) liquid biopsy platform and biologically motivated machine learning capabilities.
GRAIL Cancer Research Solution : a multi-cancer ctDNA toolkit for biopharma research and clinical testing
GRAIL’s Cancer Research Solution is a blood-only ctDNA platform for sensitive and specific cancer detection, with the aim to advance precision cancer care. With one tube of blood, the test analyzes more than a million CpGs identified through population-scale clinical studies2,3 and leverages machine learning classifiers to detect, classify, and quantify ctDNA4.
GRAIL’s Tissue-free Platform to Support Precision Cancer Care
Potential Applications Across the Cancer Care Continuum
This enables ctDNA applications spanning from exploratory research and biomarker studies to clinical trial stratification and selection. GRAIL’s Cancer Research Solution and tunable machine learning architecture are poised to support novel biopharma precision oncology strategies.
Applications and Key Publications
Detection before, during, or after treatment for risk stratification, patient selection, and minimal residual disease (MRD) assessment:
- Circulating tumor DNA (ctDNA) dynamics and treatment responses in chemotherapy-ineligible patients (pts) with unresectable stage III NSCLC from the phase II DUART trial. Ann Oncolology 2024. Abstract / Slides
- Circulating Tumor DNA (ctDNA) Clearance With Neoadjuvant Durvalumab (D) + Tremelimumab (T) + Enfortumab Vedotin (EV) for Cisplatin-Ineligible Muscle Invasive Bladder Cancer (MIBC) From the Safety Run-In Cohort of the Phase 3 VOLGA Trial. Ann Oncology 2024. Abstract / Slides
- Clinical Utility of Tumor-Naïve Pre-surgical ctDNA Detection in Early-stage NSCLC. Journal of Thoracic Oncology 2024. Manuscript
Classification utilizing methylation signatures to determine cancer signal origin, cancer subtypes or predictive signatures for precision therapies:
- Identification of cancer subtypes with a ctDNA-based targeted methylation assay. Cancer Research 2024. Abstract / Poster
- Utility of ctDNA-based Targeted Methylation MRD Assay for Hematological Malignancies. Cancer Research 2023. Abstract / Poster
- cfDNA methylation profiling distinguishes lineage-specific hematologic malignancies. Cancer Research 2020. Abstract / Poster
Quantification to determine disease burden and molecular response as surrogate for treatment efficacy:
- A Novel Tissue-Free Method to Estimate Tumor-Derived Cell-Free DNA Quantity Using Tumor Methylation Patterns. Cancers 2024. Manuscript
- Prognostic significance of blood-based multi-cancer detection in plasma cell-free DNA. Clinical Cancer Research 2021. Manuscript
- Circulating Tumor DNA Allele Fraction: A Candidate Biological Signal for Multi-Cancer Early Detection Tests to Assess the Clinical Significance of Cancers. The American Journal of Pathology 2022. Manuscript
Regulatory and Clinical Trial Capabilities
Currently the GRAIL ctDNA assay is being used in global Phase 3 clinical studies such as [NCT06564844]. Read More. GRAIL brings extensive in vitro diagnostics (IVD) development and regulatory experience as well as needed certifications to ensure international regulatory compliance.
Contact the Biopharma Partnership Team
Partner with GRAIL for your oncology diagnostic testing needs across biomarker discovery, retrospective studies and companion diagnostic tests to accelerate your efforts to bring impactful solutions.
Contact us by filling out the following form, and our team will get in touch:
Laboratory/test information
GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The RUO test was developed, and its performance characteristics were determined by GRAIL. The RUO test is For Research Use Only, Not for Diagnostic Procedures. GRAIL’s RUO product offerings have not been cleared or approved by the Food and Drug Administration.
References
1. Desai M, et al. Analytical validation of a tissue-free, multi-cancer, post- diagnosis cancer research test that uses cell-free DNA methylation profiling (LB297). American Association for Cancer Research (AACR) Annual Meeting, April 14-19, 2023, Orlando, Florida.
2. Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020;31(6):745-759. doi:10.1016/j.annonc.2020.02.011.
3. Jamshidi A, Liu MC, Klein EA, et al. Evaluation of cell-free DNA approaches for multi-cancer early detection. Cancer Cell. 2022;40(12):1537-1549.e12. doi: 10.1016/j.ccell.2022.10.022.
4. Melton CA, Freese P, Zhou Y, et al. A Novel Tissue-Free Method to Estimate Tumor-Derived Cell-Free DNA Quantity Using Tumor