Circulating tumor DNA (ctDNA) testing for minimal residual disease (MRD) can reduce costs by up to 21% across health plan populations when half of eligible patients with stage II colorectal cancer are tested for treatment decisions

SECAUCUS, N.J. and BALTIMORE, May 31, 2024 /PRNewswire/ -- A blood test could help reduce costs for health plans by reliably identifying patients who might be able to safely forgo chemotherapy after surgery for stage II colorectal cancer, according to a study published today in JAMA Health Forum, a member of the JAMA Network. Researchers from Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company and developer of the Haystack MRD™ tumor-informed ctDNA MRD technology, City of Hope and the Walter and Eliza Hall Institute of Medical Research conducted the study.

The analysis is the first of its kind published in a peer-reviewed journal to demonstrate the potential of circulating tumor DNA minimal residual disease (ctDNA MRD) tests to help reduce costs of adjuvant chemotherapy to U.S. health plans without compromising recurrence-free survival in patients with colorectal cancer.

ctDNA MRD tests are highly advanced blood or "liquid biopsy" tests that help identify early evidence of residual or recurrent cancer after surgical removal of a solid tumor.

"This study provides compelling evidence that health plans can reimburse for ctDNA MRD testing with neutral affect to their budgets while also gaining clinical insights into disease risk that other routine tests may not provide," said Afsaneh Barzi, MD, PhD, senior author of the study and a medical oncologist at Duarte Cancer Center in Duarte, California, specializing in the treatment of gastrointestinal cancers.

"We hope this latest data gives healthcare policy makers greater confidence to adopt tumor-informed ctDNA MRD testing as an economically and clinically valuable facet of colorectal cancer care," said co-author Jeanne Tie, MBChB, FRACP, MD, Medical Oncology Lead for the Lower Gastrointestinal tumor stream at Peter MacCallum Cancer Centre and a senior research fellow within the division of personalized oncology at the Walter and Eliza Hall Institute.

Building Evidence from the DYNAMIC Trial

In June 2022, a randomized clinical trial (DYNAMIC) demonstrated that a tumor-informed ctDNA MRD test performed on patients with stage II colorectal cancer reduced the application of adjuvant chemotherapy (ACT) by nearly half (15% vs. 28%) without compromising recurrence-free survival. While many patients can safely forgo ACT, physicians cannot reliably identify these patients with conventional pathological and clinical metrics. This information could help reduce the administration of ACT, thus decreasing the risk of adverse events and the related costs ($44,022 to $65,792 per patient). Results from the DYNAMIC study demonstrate that post-surgical evaluation with an appropriate ctDNA MRD test can significantly improve the identification of patients that stand to benefit from ACT.

"The DYNAMIC trial showed that testing with an appropriate tumor-informed ctDNA MRD approach more precisely identifies patients that stand to benefit from ACT," said Dan Edelstein, general manager and co-founder, Haystack Oncology. "This new study shows that the value of this new ctDNA information can help guide clinicians to make a more informed decision around ACT that benefits not only the individual patient but can also deliver broad economic benefit."

The Haystack ctDNA MRD technology is a highly optimized version of the Safe-SeqS chemistry used in the DYNAMIC study.

In the new analysis, hypothetical health plans with 1 million covered lives included 35 commercial health plan members and 102 Medicare Advantage members aged 75 years of age or younger with stage II colon cancer who were eligible for ctDNA MRD testing. The analysis compared standard clinical evaluation to a hypothetical treatment model in which 50% of patients are managed with tumor-informed ctDNA MRD testing.

Among the study's key findings:

• ctDNA MRD testing would reduce costs by 21% (1,068,040 vs. 846,356, a savings of $221,684 in total or $0.018 per member per month [PMPM]) for a commercial plan population and by 5% (2,550,029 vs. 2,433,309, a savings of $116,720 in total or $0.01 PMPM) for a Medicare Advantage plan population. Differences in cost savings between commercial and Medicare plans are related to differences in average age of plan members and associated clinical practice patterns.
• Using ctDNA MRD for greater than 50% of patients would produce even higher cost savings.
• The number-needed-to-test to avoid ACT use in one patient was estimated to be 4 in the commercial health plan population and 10 in the Medicare Advantage population.
• The budget-neutral cost for ctDNA testing was $16,202 for a commercial health plan and $5,793 for a Medicare Advantage payer. While the base-case model assumed 6 months of ACT, savings were also observed for a more conservative 3 months of therapy.

"The absolute reduction in ACT use in ctDNA-guided treatment vs. standard clinical evaluation-based treatment is expected to be the most significant factor affecting budget, based on our analysis," said lead author Yonghong Li, PhD, Director, Science and R&D, Quest Diagnostics. "If more than 50% of patients who are eligible are tested, cost savings may even be higher."

The analysis had several limitations, including lack of consideration for the costs of potential disease recurrence and mortality and uncertainty of actual ACT use rate in ctDNA-guided treatment in real-world clinical practice. Strengths included that the budget impact analysis was based on a landmark clinical trial showing the clinical utility of ctDNA testing in colon cancer and that model parameters were derived from large studies and claims in the U.S. population. This analysis provides a model where payers can input parameters observed in their health plans to estimate potential budget impact.

Quest acquired Haystack Oncology in June 2023, adding the best-in-class Haystack MRD™ tumor-informed ctDNA MRD test to its portfolio of oncology services. Quest Diagnostics and Haystack Oncology will also be exhibiting at this year's American Society of Clinical Oncology (ASCO) meeting in Chicago, IL, at booth #35145.

Colorectal cancer is among the most commonly diagnosed cancer in the United States. In 2023, an estimated 106,970 individuals were projected to be diagnosed with the disease, with up to 25% having stage II disease and 52,550 individuals succumbing to disease.¹

About Haystack Oncology
Haystack Oncology represents the culmination of over 20 years of collaboration to advance technical and clinical development in liquid biopsy technologies by cancer genomics pioneers at Johns Hopkins School of Medicine. The company, a wholly owned subsidiary of Quest Diagnostics, developed Haystack MRD™, a next generation tumor-informed approach for the measurement of minimal residual disease. Haystack MRD uses an error-corrected ctDNA technology to detect down to one ctDNA molecule in a million normal DNA molecules. Haystack Oncology works with biopharmaceutical companies to accelerate and better inform clinical development programs and advance important therapeutics to global markets, from early phase clinical development to companion diagnostics.

Haystack MRD was developed and validated in a CLIA-certified laboratory and is available for testing in clinical research in laboratories located in Baltimore, Maryland; Hamburg, Germany; and Helsinki, Finland. Quest Diagnostics is now offering the test to select providers through an early experience program and plans to launch a clinical version of the Haystack MRD™ test broadly in the U.S. later this year. Learn more at haystackmrd.com. 

About Quest Diagnostics
Quest Diagnostics works across the healthcare ecosystem to create a healthier world, one life at a time. We provide diagnostic insights from the results of our laboratory testing to empower people, physicians and organizations to take action to improve health outcomes. Derived from one of the world's largest databases of de-identifiable clinical lab results, Quest's diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors and improve healthcare management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives and create a healthier world. www.QuestDiagnostics.com.

¹ https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21772

SOURCE Quest Diagnostics