International Liquid Biopsy Standardization Alliance (ILSA)

The Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium is a host and founding partner of the International Liquid Biopsy Standardization Alliance (ILSA) Collaborative Community, which comprises organizations that recognize the importance of working towards the global use of liquid biopsy and common reference standards in oncology and seek to promote their use in the broader medical community. The ILSA partners are aligned in their common vision to bring about the ubiquitous and meritorious use of liquid biopsy to support clinical decision making and regulatory considerations, which will ultimately reduce the need for unnecessary and invasive solid tumor biopsies. Organizations joining the ILSA group share the scope of their work, discuss lessons learned and disseminate the tools and data they develop as a coordinated effort.

The ILSA partners place value in the exercise of information exchange through quarterly in-person meetings and teleconferences, which are intended to provide updates across the partnership on recent activities and to coordinate the scope and exercise of their collective efforts. The group believes in the value of disseminating accounts of its collective efforts to the broader field and publicizes its efforts through educational outreach to the scientific community.

The alliance is open to all those working in liquid biopsy, reference standards or standardization who wish to join, but is likely most suitable to public- and private-sector partners from academia, industry and government, as well as patients and end-users of genetic testing. Partners are expected to join teleconferences and face-to-face meetings and to provide input and feedback to inquiries from their colleagues. Partners are free to leave the group at any time.

Goals

ILSA would like to identify and develop a uniform end-to-end process from pre-analytic capture through technology and assay validation to clinical collection and analysis. The group hopes to promote the use of this process to allow for standardized data capture for liquid biopsy to build the necessary level of evidence required to have multiple contexts of use qualified by regulatory agencies for clinical implementation. The ILSA partners wish to encourage others in the liquid biopsy field to join the group to help harmonize the many disparate efforts that strive towards progress in achieving full “clinical utility” of liquid biopsy in the many contexts of use in which it is applicable.

Results & Accomplishments

The group submitted a white paper for review to Critical Reviews in Oncology/Hematology. The group’s Charter was submitted to FDA, which designated the group as a Collaborative Community.

Download the Charter

Partners

BloodPAC: developed a Genomic Data Commons to aggregate liquid biopsy work, now open for contribution, and developed minimum technical data elements (MTDEs) for pre-analytical variables and patient context.

European Liquid Biopsy Society: aims to become the leading hub for liquid biopsy research in Europe with the key goal to translate liquid biopsy assays into clinical practice for the benefit of patients. ELBS has replaced the successful EU/IMI CANCER-ID consortium.

International Society of Liquid Biopsy (ISLB): introduces recommendations to develop reliable and sustainable diagnostics and prognostics tools using liquid biopsies that benefit patient health management and wellness.

FNIH Biomarkers Consortium ctDNA Quality Control Materials Project: gathered multiple private sector, government agency, academic and not-for-profit partners together to characterize Quality Control Materials (QCMs) and demonstrate their comparable performance to ctDNA and their suitability to establish performance characteristics for NGS assays already in use.

Friends of Cancer Research: has developed a framework for standardizing clinical ctDNA testing and is soliciting retrospective and prospective studies to validate the hypothesis that ctDNA is reflective of outcomes. Friends’ ctDNA to MONItor Treatment Response (ctMoniTR) Project seeks to harmonize the use of ctDNA to evaluate or monitor patient response.

The Japanese bio-Measurement and Analysis Consortium (JMAC): is an industrial group established to support biotechnology with international standardization activities.

Medical Device Innovation Consortium: is a public-private partnership created to advance medical device regulatory science for patient benefit and is developing somatic reference samples in solid tissues.

NIBSC: is the WHO International Laboratory for Biological Standards and is producing the WHO 1st International Standards for circulating tumor DNA, intended for the calibration of kits, assays and secondary standards.

ILSA benefits from regulatory observance and participation from European Medicines Agency (EMA) staff and the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) is a participating partner. Collaborative Communities bring together stakeholders to achieve common outcomes, solve shared challenges, and leverage collective opportunities; more information can be found here. The ILSA collaborators are open to other groups who may have similarly aligned interests and welcome them into the community.

FNIH Contact

Dana E. Connors, Senior Scientific Project Manager, dconnors@fnih.org

Stacey J. Adam, Ph.D., Director, Cancer,  sadam@fnih.org