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Liquid Biopsy Technology – Changing the paradigm in clinical diagnostics and IVD regulatory approaches
Apr 19, 2021
Liquid biopsy technology is seeing rapid adoption in the field of clinical diagnostics, specifically in early cancer screening/detection. General consensus has been reached on the clinical utility of liquid biopsy technology as traditional tissue biopsies can be invasive, risky, and samples often insufficient for more advanced testing. Instead, liquid biopsy technology uses blood or urine tests to detect materials shed from a tumor, and can have a meaningful impact on the course of patient diagnosis and treatment (1). To date, the focus in oncology has centered primarily on therapy selection and tumor staging; two core areas gaining widespread traction are early-stage disease detection and residual disease monitoring (Tumor Mutational Burden or Minimal Residual Disease).
While much of the healthcare industry has faced uncertainties over the past 12+ months and investment changed and halted in some areas, funding seemingly flowed freely to liquid biopsy startups and M&A plans continued to make news in 2020. Notable were the announcements of Illumina to acquire Grail, Exact Sciences’ decision to acquire Thrive, Invitae’s announcement to acquire ArcherDx, and Foundation Medicine’s acquisition of Lexent Bio, to name a few.
Analysts estimate the global liquid biopsy market to be roughly $1 billion in size, with expectations to reach and exceed $5 billion by 2030. Expectations are high given the potential impact across multiple stakeholders:
- Patients: The procedure is minimally invasive, painless, and rapid
- Physicians: Given the speed and potential for precision diagnostics and targeted therapy treatment (1)
- Payers: Due to the more cost-effective shift from a surgical procedure to a potential blood draw.
Liquid biopsy companies are driving innovation in IVD through precision technology, but also through novel thinking focused on their business and commercial models. Industry is faced with an evolving regulatory landscape, methods and standards, driving change in the IVD industry and requiring greater generation of relevant and reliable real world evidence (RWE). Interestingly, many liquid biopsy companies have adopted a model already embraced by the pharmaceutical world and adopted in select medical device areas. In light of evolving regulatory processes and ISO 20916, several have turned to the use of non-interventional RWE-based studies to generate the evidence needed to prove pre-market clinical performance, as well as to conduct post-market surveillance and demonstrate ongoing safety and performance (see Figure 1 for applications of non-interventional RWE-based studies).
Figure 1: Non-Interventional Studies (NIS) in IVD
Many established companies remain hesitant to date to explore possibilities of RWE, uncertain about the validity of results in regulatory submissions. According to ISO 20916, a clinical performance study can be a NIS (see Figure 2).
Figure 2: Clinical Performance Study Flowchart (2)
Most of the regulatory bodies across the world have increased the value they place on RWE in their latest regulations. Several regulatory agencies have developed comprehensive and accessible guidance documents to help IVD companies be successful in their regulatory applications/submissions using RWE (see Figure 3).
Figure 3: Latest Regulations for Medical Devices and IVD
Working with the partner who is rooted in RWE and has strong clinical study experience is key for all IVD manufacturers in this continuously evolving regulatory environment. RWE-based studies may facilitate a more cost-effective and timely way to demonstrate performance and value. IQVIA MedTech drives value and innovation to IVD RWE studies by focusing on three key success factors:
- A patient-centric approach
- Data integration, and
- Technology and IVD Study Delivery Expertise.
Our MedTech RWE Expert team is committed to train, answers questions, guide in strategy, provide operational inputs and alternative solutions in order to help IVD companies maximize the potential of their products across the full lifecycle. For a free on-demand workshop to learn more about the value of RWE-based trials, please contact Estelle Frappe at estelle.frappe@iqvia.com
1. Penn Medicine, Philadelphia, PA 800-789-7366 © 2020, The Trustees of the University of Pennsylvania
2. ISO 20196 – In vitro diagnostic medical device – Clinical performance studies using specimen from human subjects – Good Study Practice