DELFI Diagnostics Presents Additional Promising Proof-of-Concept Data on its Monitoring Program at AACR 2023

ORLANDO, Fla., April 18, 2023 /PRNewswire/ -- DELFI Diagnostics, Inc., a pioneering developer of a new class of high-performance, accessible liquid biopsy tests for early cancer detection and monitoring, presented proof-of-concept data demonstrating how DELFI's platform can be used for monitoring the treatment of patients with advanced cancer without requiring any prior genomic information about the patient's tumor. The data were presented at the American Association for Cancer Research (AACR) 2023 Annual Meeting and builds on earlier studies showing the potential of using DELFI's technology for treatment monitoring. 

The DELFI-Tumor Fraction (DELFI-TF) score tracked mutant-allele fraction scores (MAFs) in side-by-side assessments, and also identified cancer signals in patients with clinical disease burden who had false negative MAF assays. Today, MAF assays are a common clinical measure of tumor burden. Researchers demonstrated that the DELFI-TF score and MAF results were equally predictive of clinical outcomes, and that changes in DELFI-TF scores over time anticipated later changes in radiologic assessments of disease response.

"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, DELFI's Chief Medical Officer. "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."

Researchers from DELFI and the Netherlands Cancer Institute, and the University Medical Center Utrecht looked at 174 patients undergoing therapy for metastatic colorectal cancer and collected a total of 692 blood samples at various time points before and after treatment. They found that the DELFI-TF score predicted survival outcomes in the overall study population, regardless of the patient's BRAF or RAS status, two genes that are commonly mutated in CRC. Patients whose change in DELFI-TF was below the median over time showed both longer progression-free survival (HR = 2.03, 95% CI: 1.247-3.318) and overall survival (HR = 3.05, 95% CI: 1.58 - 5.90).

The study builds on prior work demonstrating the potential of the DELFI platform to monitor patients with metastatic cancer undergoing treatment with immunotherapy. In that study, presented at ESMO in 2022, researchers showed that the DELFI-TF score was as effective as imaging at tracking progression and progression-free survival. The work was awarded "Best Poster" in the Translational Research, Tumor Agnostic session.

"This is another example of the power of DELFI's unique platform to provide high quality results using low-cost methods and a common wet-lab process that is used in all our applications and products in development," said Nicholos Dracopoli, PhD, DELFI Co-Founder and Chief Scientific Officer.

Also at AACR, DELFI and other researchers using the DELFI platform presented data describing the platform's strong performance in a training set that will be used to develop DELFI's first lung cancer screening product. Researchers also shared promising initial data on the DELFI platform's ability to detect early stage ovarian cancer.

DELFI Diagnostics is developing a new class of liquid biopsy tests for early cancer detection based on altered genome-wide fragmentation profiles, also known as "fragmentomes," representing aberrant packaging of DNA in cancer cells. By applying advanced machine learning algorithms, these fragment patterns are detectable at a very low sequencing cost. DELFI ("DNA EvaLuation of Fragments for early Interception") is using this technology to develop highly sensitive and specific cancer detection assays intended for wide and cost-effective distribution and adoption globally.

SOURCE DELFI Diagnostics