Foresight Diagnostics, a leader in ultra-sensitive minimal residual disease (MRD) detection technology, today announced the launch of SHORTEN-ctDNA, a clinical trial at Columbia University.¹ The study aims to evaluate the ability to utilize Foresight CLARITY™ MRD detection to enable real-time treatment optimization for patients with diffuse large B-cell lymphoma (DLBCL).

Currently the standard treatment for newly diagnosed DLBCL requires six cycles of combination rituximab and chemotherapy regardless of individual patient response. This one-size-fits-all approach leaves little room for personalization, potentially exposing patients to unnecessary treatment. The SHORTEN-ctDNA trial will investigate whether patients who achieve early clearance of circulating tumor DNA (ctDNA) can safely receive fewer cycles of chemotherapy while maintaining long-term survival outcomes.

"Although PET scans remain our standard tool for monitoring lymphoma treatment, their inconsistent results in identifying active disease limit our ability to make real-time treatment decisions," said David Kurtz, MD, PhD, Chief Medical Officer and Head of Research at Foresight Diagnostics. "Foresight CLARITY's detection of residual disease could be the game-changer we need, potentially allowing us to confidently adjust therapy based on each patient's actual response to treatment with a more dynamic and sensitive tool than imaging."

The study will enroll approximately 32 newly diagnosed DLBCL patients. After three cycles of R-CHOP or pola-R-CHP therapy, participants will undergo ctDNA testing. Those with detectable disease (MRD-positive) will continue with rituximab plus chemotherapy for their remaining cycles, while patients who achieve undetectable ctDNA levels (MRD-negative) will de-escalate to rituximab alone for their final two cycles.

"Recent evidence suggests many patients achieve very deep remissions earlier in their R-chemo treatment than previously thought," said Hua-Jay Cherng, MD, assistant professor of medicine at Columbia University Vagelos College of Physicians and Surgeons and Principal Investigator of the study. "By using next-generation, ultra-sensitive ctDNA technology, SHORTEN-ctDNA aims to identify these early responders and personalize their treatment strategy, potentially reducing treatment duration and associated toxicity and hopefully getting patients back to their normal lives sooner."

More information on the trial may be found here.

^{1 Full official title of trial: “Sequencing-guided cHemotherapy Optimization Using Real-Time Evaluation in Newly Diagnosed DLBCL With circulating tumor DNA: SHORTEN-ctDNA."}

About Foresight Diagnostics

Foresight Diagnostics is a privately-held cancer diagnostics company and CLIA-registered 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 Twitter and LinkedIn. Foresight CLARITY™ IUO is an investigational device. Limited by United States Law to investigational use.

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