Creating Standards for Liquid Biopsies: the BLOODPAC Experience
Since the first Food and Drug Administration (FDA) approval in 2013, liquid biopsy-based platforms have transformed the precision management of patients with advanced cancer [1]. Liquid biopsy holds a demonstrated role in precision medicine that historically focused on targeted therapy selection. Yet, continued innovation is expected to drive growing utility for liquid biopsy-based tests in other areas of clinical need, including minimal (or molecular) residual disease monitoring and early-stage cancer screening.
As with any novel medical technology, the clinical potential of liquid biopsy cannot be realized without acceptance by stakeholders within the biomedical and healthcare ecosystem. This creates an urgent need to establish best practices for test development and validation and to support shared standards that lessen the burden on regulators, clinicians, patients, and payers. This framework could only be generated through an exceptional degree of collaboration among stakeholders and industry experts in this highly competitive field.
In 2016, when then-U.S. Vice President Joe Biden launched the Cancer Moonshot, the call-to-action catalyzed a collective effort to overcome hurdles in the development, validation, and clinical adoption of liquid biopsy for the benefit of patients [2]. When Blood Profiling Atlas in Cancer (BLOODPAC, also denoted as ‘BloodPAC’) formed in late 2016, it was with a clear understanding of the challenge: without a common ‘yardstick’ to guide the development and evaluation of these tests, the clinical benefits for patients would be slow to materialize.
A competitive marketplace fuels innovation. Yet, with a novel technology like liquid biopsy, competition must be grounded in broad understanding, trust, and a shared vision for standards of excellence [3]. At its inception, BLOODPAC members recognized that no single entity could establish these essential elements for a healthy competitive space. This understanding took root and, since 2016, the consortium has grown to include over 60 collaborators – diagnostic developers, pharmaceutical companies, academic institutions, nonprofit organizations, private payers, standards-setting organizations, and federal agencies – all working within ten different working groups [4].
Other industry collaborations exist to establish best practices, like Friends of Cancer Research, Quality Assurance Initiative in Pathology, and the Clinical and Laboratory Standards Institute [5–7]. BLOODPAC fills a void where guidelines do not exist. The consortium is working to address the unmet need by providing guidance for the industry, collaborating with government and other regulatory agencies, and leveraging expertise through the organization’s diverse membership.