Revolutionizing Cancer Care: New NCCN Guidelines Embrace ctDNA-MRD Testing

BOULDER, Colo., Jan. 10, 2025 (GLOBE NEWSWIRE) — Foresight Diagnostics, a pioneer in ultra-sensitive minimal residual disease (MRD) detection technology, has announced today the incorporation of circulating tumor DNA (ctDNA) testing into the National Comprehensive Cancer Network^® (NCCN^®) Clinical Practice Guidelines in Oncology for diffuse large B-cell lymphoma (DLBCL). This follows the company’s submission of clinical guidelines to the NCCN in August 2024. This represents the inaugural inclusion of ctDNA-MRD testing in these guidelines, signifying a substantial leap forward in the treatment of lymphoma patients.

“This achievement marks a pivotal moment in lymphoma care and showcases the commitment of numerous researchers, oncologists, patients, and the entire Foresight team,” stated David Kurtz, MD, PhD, Chief Medical Officer and co-founder of Foresight Diagnostics. “By including ctDNA testing in the NCCN Guidelines, Foresight moves closer to our goal of enhancing the lives of cancer patients globally through the delivery of innovative diagnostics that equip clinicians with actionable tools for making informed treatment choices.”

The revised guidelines now encompass ctDNA-MRD evaluation as a substitute for biopsy when assessing PET-positive findings at the conclusion of first-line treatment in DLBCL. Specifically, for patients exhibiting partial response or progressive disease following therapy, as indicated by PET imaging, the guidelines endorse ctDNA-MRD testing. Patients who are PET-positive but ctDNA-MRD negative can proceed along the PET-negative pathway, involving clinical and imaging follow-up. The guidelines stipulate that only ctDNA-MRD assessments utilizing an assay limit of detection below one part per million should be applied, in accordance with Foresight’s CLARITY™ MRD test performance.¹

“Up until now, managing patients with a positive or indeterminate PET scan post-therapy has been a difficult challenge, particularly when biopsy is infeasible. Moreover, PET scans have a false positive rate, where 50% or more of positive scans are not attributable to residual lymphoma,” remarked Mark Roschewski, MD, Senior Clinician and Clinical Director of the Lymphoid Malignancies Branch at the Center for Cancer Research.² “The addition of ctDNA testing in the NCCN Guidelines equips us with a robust tool to tackle both issues—providing clarity when a biopsy isn’t viable and aiding in more accurately identifying which patients genuinely require further therapy.”

“These new guidelines also represent a notable advance in minimizing unnecessary procedures and the treatment load for lymphoma patients,” added Ash Alizadeh, MD, PhD, co-founder of Foresight Diagnostics and Professor of Medicine, Oncology, and Hematology at Stanford University. “In situations where PET scans show positive results, patients frequently undergo invasive procedures for confirmation. Conversely, if results are unconfirmed and the scan reveals a false positive, patients are subjected to additional treatment that may be unnecessary. By employing ctDNA-MRD testing to adjudicate such scenarios, we can now more effectively identify which patients can safely avoid further treatment, thus sparing them from significant toxicities and the emotional, physical, and financial strains of unnecessary interventions.”³

This update from the NCCN comes after Foresight’s submission of clinical suggestions in August 2024 for the inclusion of ctDNA testing in the NCCN guidelines, leveraging evidence generated by Foresight CLARITY™. The updated guidelines are presently accessible 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,

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 owned cancer diagnostics company and CLIA-certified laboratory. Its liquid biopsy platform, Foresight CLARITY™, is an innovative assay that quantifies minimal residual disease (MRD) with reported detection limits in parts per million. The enhanced sensitivity of Foresight CLARITY™ offers the potential to provide actionable insights to healthcare professionals and biopharmaceutical companies, enabling more personalized treatment strategies for patients with solid tumor and hematologic malignancies. For further information, please visit foresight-dx.com and follow us on X, LinkedIn, and Bluesky. Foresight CLARITY™ IUO is an investigational device, restricted by United States Law to investigational use.

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