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The Future of Liquid Biopsies: Endless Possibilities for Cancer Testing

Liquid biopsies are poised to disrupt cancer testing as we know it. These novel blood tests analyze circulating tumor DNA (ctDNA) and other molecules released by cancer cells, providing a non-invasive option for detection, diagnosis, and monitoring. The promise of liquid biopsies has generated tremendous excitement, along with over $1 billion in investments and acquisitions in recent years. But how close are we to realizing their full potential? 




A recent review article sounds a note of caution amidst the hype. While liquid biopsies show ability to detect cancer, evidence that they improve patient outcomes is still lacking. Randomized trials with survival endpoints are needed to prove clinical utility. However, this provides the perfect opportunity for innovative diagnostics companies. Rather than dampening enthusiasm, these evidence gaps highlight major growth possibilities if companies can demonstrate real-world value.  

We envision liquid biopsies transforming oncology across three horizons:

Near-term: Expanding proven applications

Liquid biopsies are already endorsed to identify targetable mutations when tissue is insufficient. But less than 40% of early-stage lung cancers are detected. Improving sensitivity could expand use for therapy selection. Liquid biopsies have also shown promise to monitor minimal residual disease after surgery or reduce reliance on chemotherapy. Turning these proofs of concept into standard practice requires robust clinical validation and commercialization.  

Mid-term: Unlocking new applications

On the horizon are opportunities to diagnose suspected cancers, guide immunotherapy, and assess early response to chemotherapy. But questions remain about how liquid biopsies add value over current protocols. Innovative clinical trial designs are critical to integrate liquid biopsies into care pathways. Defining algorithms for follow-up of positive results can also increase utility. Further in the future, major investment will be needed to demonstrate liquid biopsies enable early detection and improve cancer mortality—the most disruptive possibility.  

Long-term: Enabling a revolution in cancer care

Ultimately, liquid biopsies’ ability for repeat, non-invasive sampling enables a fundamental shift to dynamic, personalized management based on the current state of a patient’s tumor. Regular liquid biopsies over the full course of disease can potentially track response, evolution, and emergence of resistance in real-time. This could replace the current paradigm of single static snapshots from tissue biopsies. Realizing this future requires building an entirely new liquid biopsy-centered oncology infrastructure.

Medicare Coverage is Critical to Unlock Liquid Biopsy Potential

As companies pursue this stepwise roadmap to transform cancer care with liquid biopsies, Medicare coverage and reimbursement will play a crucial role. Oncology is a Medicare-driven market, with over 60% of cancer care paid by the national health insurance program for seniors.


Unfortunately, coverage of liquid biopsies under Medicare has lagged behind their rapid technical development. Medicare coverage of liquid biopsy tests continues to evolve with limited coverage for the diagnosis of non-small cell lung cancer along with use in MRD. Many other uses of liquid biopsies are still considered investigational by payers.


Gaining Medicare coverage will require clinical studies producing real-world evidence of clinical utility and cost-effectiveness. Companies that engage with Medicare early and invest in pivotal trials designed to meet reviewers’ evidentiary standards will have an advantage. Initial coverage in limited patient populations can be expanded over time as new data emerges.


Proposed legislation like the Medicare Multi-Cancer Early Detection Screening Coverage Act also seeks to accelerate coverage for broad screening applications of liquid biopsies. However, many experts caution that major clinical unknowns remain which need to be addressed first.


In summary, intelligently designed clinical research and proactive payer engagement are instrumental for companies to unlock the full potential of liquid biopsies. Medicare coverage and payment remain key hurdles on the path to widespread adoption. Our firm brings deep expertise in clinical and coverage strategy to help clients navigate this dynamic landscape.


Let’s connect to explore how we can partner to drive access to your liquid biopsy assays and ensure coverage and reimbursement success!

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