Newly Launched Assay May Improve Monitoring of Cancer Treatment Response

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DELFI Diagnostics announced the official launch of its fragmentome-based research use only (RUO) cancer monitoring assay, the DELFI-Tumor Fraction assay (DELFI-TF). This assay, based on analyzing the fragmentome—the entirety of cell-free DNA fragments in the blood—offers a cost-effective, sensitive method for detecting changes in tumor DNA without the need for invasive procedures, according to the company.¹

As part of the launch, DELFI also announced that it has entered into a research collaboration with Immunocore Holdings plc in order to investigate the potential of the DELFI-TF assay in predicting the effectiveness of ImmTAC-based treatments early in the therapy process.¹

"The DELFI-TF assay delivers a genome-wide measure of the proportion of cfDNA derived from a tumor and it is highly correlated with the mutant allele fraction (MAF) that is often used to evaluate treatment response and resistance to immunotherapies in advanced cancer patients. Our fragmentome-based assay has numerous advantages as it requires very little plasma, has a low cost of processing, and is not confounded by clonal hematopoiesis or driver mutation switches," said Nicholas C. Dracopoli, PhD, co-founder, chief scientific officer, DELFI, in a company press release. "We are excited that Immunocore will be further exploring the clinical and research potential of the DELFI liquid biopsy platform as a new approach to monitoring treatment response."

Early last year, DELFI presented promising proof-of-concept data for the DELFI-TF at the American Association for Cancer Research (AACR) annual meeting.²

In its study, DELFI recruited 174 patients with metastatic colorectal cancer, analyzing 692 blood samples to explore the DELFI-TF score's ability to predict survival outcomes. Results indicated that patients with changes in the DELFI-TF score below the median experienced longer progression-free survival and overall survival, irrespective of their BRAF or RAS mutation status, which are commonly altered genes in colorectal cancer.

"Legacy liquid biopsy approaches to cancer treatment monitoring rely either on prior knowledge about the genomic makeup of a patient's tumor or deep sequencing looking for expected alterations. Each approach is high cost, and subject to various types of errors and failures," said Peter Bach, MD, chief medical officer, DELFI, in a company press release. "These proof-of-concept findings show that the whole-genome fragmentation analysis that underlies the DELFI-TF assay could be used to measure tumor burden, patient prognosis, and treatment response without the need for tumor tissue."

References

1. DELFI Diagnostics Announces Availability of New Fragmentome-Based Cancer Treatment Monitoring Assay. PR Newswire. February 1, 2024. Accessed February 1, 2024. https://www.prnewswire.com/news-releases/delfi-diagnostics-announces-availability-of-new-fragmentome-based-cancer-treatment-monitoring-assay-302049894.html
2. DELFI Diagnostics Presents Additional Promising Proof-of-Concept Data on its Monitoring Program at AACR 2023. PR Newswire. April 18, 2023. Accessed February 1, 2024. https://www.prnewswire.com/news-releases/delfi-diagnostics-presents-additional-promising-proof-of-concept-data-on-its-monitoring-program-at-aacr-2023-301800581.html