NCCN Guidelines Updated to Include ctDNA-MRD Testing Recommendation for B-Cell Lymphoma
BOULDER, Colo., Jan. 10, 2025 (GLOBE NEWSWIRE) — Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, today announced the inclusion of circulating tumor DNA (ctDNA) testing in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for diffuse large B-cell lymphoma (DLBCL), following the company’s submission of clinical recommendations to the NCCN in August 2024. This marks the first-ever inclusion of ctDNA-MRD testing in these guidelines, representing a significant advancement in lymphoma patient care.
“This milestone represents a transformative moment in lymphoma and reflects the dedication of countless researchers, oncologists, patients, and the entire Foresight team,” said David Kurtz, MD, PhD, Chief Medical Officer and co-founder of Foresight Diagnostics. “The inclusion of ctDNA testing in the NCCN Guidelines brings Foresight closer to our mission of improving the lives of cancer patients worldwide by delivering innovative diagnostics that provide clinicians with actionable tools to make informed treatment decisions.”
The updated guidelines now incorporate ctDNA-MRD assessment as an alternative to biopsy for evaluating PET-positive results at the end of first-line therapy in DLBCL. Specifically, for patients with partial response or progressive disease at the end of therapy based on PET imaging, the guidelines include ctDNA-MRD testing. Patients who are PET-positive but ctDNA-MRD negative can follow the PET-negative pathway, which includes clinical and imaging follow-up. The guidelines specify that only ctDNA-MRD assessments with an assay limit of detection of less than one part per million should be used, which aligns with Foresight’s CLARITY™ MRD test performance.1
“Until now, management of patients with a positive or equivocal PET scan at the end of therapy has been a challenging issue, particularly when biopsy is not possible. Furthermore, PET scans have a false positive rate, where 50% of positive scans or more are not due to residual lymphoma,” said Mark Roschewski, MD, Senior Clinician and the Clinical Director of the Lymphoid Malignancies Branch of the Center for Cancer Research.2 “The inclusion of ctDNA testing in the NCCN Guidelines gives us a powerful tool to address both challenges – providing guidance when biopsy isn’t possible and helping us more accurately determine which patients truly need additional therapy.”
“These updated guidelines also represent a significant step forward in reducing unnecessary procedures and treatment burden for lymphoma patients,” added Ash Alizadeh, MD, PhD, co-founder of Foresight Diagnostics and Professor of Medicine, Oncology, and Hematology at Stanford University. “When PET scans are positive, patients often undergo invasive procedures to confirm the result. Or, if results are not confirmed and the scan reflects a false positive, patients are exposed to additional treatment that they don’t actually need. By using ctDNA-MRD testing to adjudicate these cases, we can now better identify which patients can safely avoid further treatment, sparing them from significant toxicities and the physical, emotional, and financial burden of unnecessary interventions.”3
This update by the NCCN follows Foresight’s submission of clinical recommendations in August 2024 for the inclusion of ctDNA testing in NCCN guidelines, utilizing evidence generated by Foresight CLARITY™. The guidelines are now available on NCCN’s website.
References
1 Boehm, Nina, et al. “Analytical Validation of a Circulating Tumor DNA Assay using PhasED-Seq Technology for Detecting Residual Disease in B-Cell Malignancies.” medRxiv, 9 Aug. 2024, https://doi.org/10.1101/2024.08.09.24311742.
2 Moskowitz, Craig H et al. “Risk-adapted dose-dense immunochemotherapy determined by interim FDG-PET in Advanced-stage diffuse large B-Cell lymphoma.” Journal of clinical oncology : official journal of the American Society of Clinical Oncology vol. 28,11 (2010): 1896-903. doi:10.1200/JCO.2009.26.5942; Kostakoglu, Lale et al. “End-of-treatment PET/CT predicts PFS and OS in DLBCL after first-line treatment: results from GOYA.” Blood advances vol. 5,5 (2021): 1283-1290. doi:10.1182/bloodadvances.2020002690
3 Roschewski, et al. “End of Treatment Response Assessment After Frontline Therapy for Aggressive B-cell Lymphoma: Landmark Comparison of a Singular PET/CT scan vs Ultrasensitive Circulating Tumor DNA.” Presented at ASH 2023; Cliff, et al. “Using circulating tumor DNA to spare patients with diffuse large B-cell lymphoma unnecessary treatment and cost: a model based analysis.” Presented at ASH 2024.
About Foresight Diagnostics
Foresight Diagnostics is a privately held cancer diagnostics company and CLIA-certified laboratory. Its liquid biopsy platform, Foresight CLARITY™, is a novel assay that measures minimal residual disease (MRD) with reported detection limits in parts per million. The improved sensitivity of Foresight CLARITY™ has the potential to provide actionable information to physicians and biopharmaceutical companies to enable more personalized treatment approaches for patients with solid tumor and hematologic malignancies. For more information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.
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