How MRD testing is improving cancer care and opening new opportunities in oncology

The field of oncology is evolving, and one of the drivers of this change is the growing adoption of minimal residual disease (MRD) testing. While traditional imaging and blood tests often fall short of identifying MRD in its earliest stages, recent advancements in MRD-testing technologies are helping clinicians detect cancer cells earlier, providing crucial insights into cancer progression, recurrence, and treatment effectiveness.

As the MRD testing market expands, it’s also opening opportunities for companies in oncology diagnostics and therapeutics. Here’s a look at the key drivers behind this market growth, the technological innovations at play, and the value for companies in the MRD space.

The growth of the MRD testing market

The global MRD testing market is experiencing significant growth and is projected to reach $4.45 billion by 2031. This expansion is driven by several key factors: the increasing global incidence of cancer, the rising emphasis on personalized oncology, and the high recurrence rates seen in many cancers. According to the World Health Organization (WHO), over 35 million new cancer cases are predicted in 2050. Furthermore, emerging economies are adopting MRD testing as healthcare infrastructure improves, further fueling market expansion.

Technological advancements fueling MRD testing

Technological innovations have improved the sensitivity and precision of MRD testing, with advancements in flow cytometry and genomic methods. These improvements have enhanced assay sensitivity, detection limits, and reduced turnaround times for MRD results, driving its growing adoption in both clinical settings and research. Below are three key technologies leading the way in advancing MRD testing:

• Multi-parameter flow cytometry (MPFC): MPFC provides real-time, quantitative data on the presence and number of cancer cells in a sample, offering insights into the cancer burden and facilitating more accurate treatment decisions.
• Next-generation sequencing (NGS): NGS enables the detection of very small amounts of cancer-related DNA circulating in the bloodstream, offering unprecedented sensitivity and providing detailed insights into disease status, even at low tumor burdens. Most MRD tests currently use NGS to detect circulating tumor DNA (ctDNA).
• Digital PCR and quantitative PCR (qPCR): These molecular techniques allow for highly accurate detection of specific genetic mutations, providing a molecular snapshot of a patient's disease progression.

As these technologies continue to evolve, they promise to improve MRD testing's ability to identify residual disease at earlier stages, improving treatment outcomes for patients and further driving the growth of the MRD testing market.

Expanding the role of MRD testing in oncology

The clinical use of MRD tests is growing every year as evidence builds supporting the benefits for patients. While MRD testing has long been used in hematological cancers such as chronic myeloid leukemia (CML), acute promyelocytic leukemia (APL), and acute lymphoblastic leukemia (ALL), its potential is expanding into solid tumors—essentially all other types of cancer.

In hematological cancers, MRD testing has already proven to be a valuable tool in monitoring treatment response. For instance, patients with CML who achieve deep molecular responses (DMR) can consider treatment cessation, with MRD testing acting as an early warning for relapse.

Similarly, in solid tumors, MRD testing can be performed during or after neoadjuvant therapy to detect circulating cancer cells, helping clinicians make more informed decisions about subsequent treatments or surgery. A prime example of MRD testing in solid tumors is Natera’s Signatera, a tumor-informed assay currently covered by Medicare for patients with colorectal cancer, muscle-invasive bladder cancer, breast cancer, and ovarian cancer. Additionally, its broad pan-cancer test is used to monitor immunotherapy response across various solid tumor types.

As MRD testing continues to expand into new cancer types and applications, it’s poised to unlock additional clinical and commercial opportunities, reinforcing MRD testing as a crucial component of cancer care.

MRD testing in clinical trials and drug development

Building on its clinical applications, MRD testing is also gaining traction in oncology research. The FDA has published a draft guidance on the use of circulating tumor DNA (ctDNA) analysis for MRD detection in clinical trials. Potential applications include:

• Assessing trial eligibility (e.g. enrolling only MRD-positive patients)
• Stratifying study populations (e.g. creating MRD-positive and MRD-negative arms)
• Guiding treatment decisions using MRD status (e.g. escalating or de-escalating experimental treatments)

Foundation Medicine’s FoundationOne is an example of a ctDNA test that is used in research to monitor cancer treatment response and detect resistance. It analyzes blood samples to track ctDNA levels and genetic changes across over 300 genes, providing insights for clinical decision-making in early-phase trials.

MRD testing is also being explored as an early endpoint in oncology trials. While overall survival (OS) remains the gold standard, it demands extensive follow-up, making it costly and less practical for slow-progressing cancers. Early endpoints, on the other hand, can be measured sooner, which may help shorten trial duration and speed up time-to-approval for new treatments.

Collaboration among test developers, regulatory agencies, and other key stakeholders will be crucial to advancing the use of MRD testing in clinical trials and drug development.

The clinical and business value of MRD-testing

The rise of MRD testing represents an exciting new frontier in cancer care. For healthcare providers, incorporating MRD testing into clinical practice could mean earlier detection of cancer recurrence, allowing for more personalized treatment plans that can significantly improve patient outcomes. By identifying minimal residual disease before it becomes clinically evident, providers can adjust therapies quickly, giving patients the best chance for long-term survival.

For organizations in the cancer diagnostics and treatment sectors, MRD testing offers a growing market with significant potential. This market includes assay kits, diagnostic instruments, and platforms used by labs, hospitals, and research institutions. Whether tapping into this expanding market by developing new testing technologies, forming partnerships with cancer centers or research institutes, or helping healthcare providers integrate MRD testing into standard care practices, there is a clear path forward for organizations looking to make an impact in the MRD-testing space.

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