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ASH Annual Meeting and Exposition
Meet Veristat at ASH Meeting and Exposition December 6-9, 2025
Veristat is excited to attend the ASH Annual Meeting and...
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The promise of circulating tumor DNA (ctDNA) extends far beyond simply detecting cancer; it also holds potential for personalized treatment. As Dr. Gabriela Rosu, Veristat’s Vice President, Global Medical Affairs, recently explained, "If we know that this clone is sensitive to this treatment, we're going to be able to treat these patients in a non-blinded way."
This vision represents a fundamental shift from the traditional approach of cancer treatment, from broad, population-based therapies to precise, clone-specific interventions guided by real-time molecular intelligence. And while the classic tissue biopsy can offer this information as well, the convenience of a blood sample versus tissue biopsy can be a major advantage.
From Detection to Selection: The Precision Medicine Evolution
While much of the ctDNA discussion focuses on early detection and monitoring, ctDNA can have an impactful role in treatment selection. Dr. Rosu emphasizes that we're moving toward a future where "we hopefully reduce the chances of progression" by matching more precise treatments to the molecular characteristics of individual tumor clones.
Current clinical trials are already demonstrating this potential. The CCGA study has shown that ultra-deep sequencing of cfDNA combined with machine learning algorithms can not only detect multiple cancer types but also predict treatment responses based on specific genomic alterations. This approach goes beyond simple mutation detection to encompass tumor mutational burden, microsatellite instability, and mutational signatures.
Real-Time Treatment Optimization
Unlike tissue biopsies that provide a snapshot in time, ctDNA offers continuous monitoring of tumor evolution. As treatments exert selective pressure, resistant clones emerge and can be detected in circulation before clinical progression becomes apparent.
Dr. Rosu notes the excitement of working closely with Veristat sponsors in clinical research: "Being directly involved in clinical trials, we now have the chance to see this data being generated firsthand. Recent trials in breast cancer demonstrate this principle. The PALOMA-3 study showed that patients acquiring new mutations during CDK4/6 inhibitor treatment could be identified through ctDNA monitoring, enabling timely treatment switches before radiographic or clinical progression.
Addressing the Clone Sensitivity Challenge
The concept of clone-specific treatment sensitivity represents a paradigm shift. Rather than treating cancer as a uniform disease, ctDNA analysis reveals the heterogeneous nature of tumors and their differential responses to therapy.
"We don't have all the answers, but hopefully we're going to be able to progress quickly in terms of screening and early detection and a better way of treating these patients," Dr. Rosu acknowledges. This honesty about current limitations doesn't diminish the revolutionary potential. Rather, it emphasizes the importance of continued research and clinical validation.
Overcoming Current Limitations
Several challenges must be addressed to fully realize ctDNA's potential in treatment selection:
Analytical Sensitivity: Current assays may miss low-level mutations that could predict resistance. Ultra-sensitive approaches using tumor-informed assays achieve detection limits of 0.001-0.01% variant allele frequency.
Clonal Hematopoiesis: Age-related mutations in blood cells can confound ctDNA analysis. Sophisticated bioinformatics approaches and matched normal samples help distinguish tumor-derived from hematopoiesis-derived mutations.
Temporal Dynamics: The timing of ctDNA sampling relative to treatment administration affects detection sensitivity. Standardized protocols for sample collection and analysis are essential.
The CRO Advantage in Development
Partnering with a clinical research organization (CRO) like Veristat provides unique advantages in developing ctDNA-guided treatment strategies. As Dr. Rosu explains, "This is one of the beauties of working in a CRO. We have the opportunity to see all of this data firsthand."
At Veristat, this direct exposure to cutting-edge clinical trials enables us to:
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Identify patterns across multiple studies and therapeutic areas
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Develop standardized approaches for ctDNA integration
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Understand the practical challenges of implementing precision medicine
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Bridge the gap between research discoveries and clinical application
Future Implications
The evolution from cancer detection to treatment selection represents more than a technological advancement, it's a fundamental reimagining of cancer care. Instead of applying treatments and waiting to see if they work, we're moving toward a model where treatment decisions are based on molecular evidence of likely efficacy.
Dr. Rosu's vision of treating patients "in a non-blinded way" based on clone sensitivity could dramatically improve outcomes while reducing unnecessary toxicity. This approach promises not just better cancer treatment, but more personalized, efficient, and humane care.
As clinical trials continue to validate these approaches, the question isn't whether ctDNA will revolutionize treatment selection, but how quickly we can implement these advances in routine clinical practice. The data emerging from current trials suggests that the future is closer than we might think.
Where Data Becomes Direction
Guiding smarter clinical decisions — from design to registration.
At Veristat, data isn’t just collected; it’s interpreted, modeled, and transformed into direction. For more than 30 years, we’ve helped clients find clarity in complexity, guiding smarter decisions from trial design through regulatory submission. Every insight we deliver moves programs forward, because in every great study, data isn’t the destination; it’s the direction.
Learn more about Veristat’s medical affairs and patient safety expertise—where signals become safety— to discover how we transform real-world evidence into actionable insight for ongoing confidence.