DELFI Diagnostics Working with Incendia Therapeutics to Employ Advanced Treatment Monitoring Test in a Phase 1 Clinical Trial

October 28, 2024 |

3 min read

Innovative Assay Aims to Enhance Patient Outcomes through Precision Medicine

PALO ALTO, Calif. and CAMBRIDGE, Mass., Oct. 28, 2024 /PRNewswire/ -- DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, today announced that Incendia Therapeutics will use the DELFI-TF Monitoring assay as part of their suite of assays for evaluation of treatment response and disease progression in patients enrolled in their Phase I clinical trial (NCT05753722).

“Incendia is committed to the development of novel, precision medicines for patients in need. Innovative products, such as those being developed by DELFI, will aid in the efficient progress of those medicines through the clinic,” said Susan Macdonald, PhD, SVP Nonclinical Development & Strategy at Incendia Therapeutics, commenting on how the relationship leverages the strengths of both companies to bring a state-of-the-art detection tool to scientific researchers looking to develop precise treatment monitoring.

“The DELFI-TF assay provides a unique, cost-effective approach to monitoring cfDNA from patients in clinical research studies, providing evidence of the efficacy of a New Molecular Entity (NME) in the earliest phases of clinical development,” said DELFI Diagnostics Co-Founder and Chief Scientific Officer, Nicholas Dracopoli. “The DELFI-TF assay will provide Incendia with valuable insights to help them manage their Phase 1 program.”

One key advantage of the DELFI TF assay is that it requires under 1 mL of plasma — considerably less than the volume needed for other cfDNA assays. This low volume is particularly beneficial in early clinical studies that require large volumes of blood for other assessments, such as pharmacokinetic (PK) analyses.

About DELFI Diagnostics

DELFI Diagnostics is developing next-generation, blood-based tests that are accurate, accessible, and deliver a new way to help detect cancer. DELFI tests are built to solve the highest-burden population health issues, including in historically underserved demographics, and have the potential to save lives on a global scale. FirstLook Lung, for individuals eligible for lung cancer screening, is our first laboratory-developed screening test and requires a simple blood draw that can be incorporated with routine blood work. The test is based on fragmentomics, the discovery that cancer cells are more chaotic than normal cells and, when they die, leave behind tell-tale patterns and characteristics of cell-free DNA (cfDNA) fragments in the blood. The DELFI platform applies advanced machine-learning technology to whole-genome sequencing data to assess individuals’ cfDNA fragments against populations with and without cancer. FirstLook Lung uses these millions of data points to reliably identify individuals who may have cancer detected through low-dose CT, including early-stage disease, with a negative predictive value of 99.8 percent. This test has not been cleared or approved by the FDA. To learn more about the FirstLook Lung test, visit www.delfidiagnostics.com or www.firstlooktest.com.

About Incendia Therapeutics

Incendia Therapeutics is discovering and developing a novel class of experimental therapeutics that reprogram the tumor microenvironment (TME). Incendia’s platform is based on rigorous, groundbreaking research involving spatial characterization of the tumor microenvironment, multi-omics data integration, and extensive preclinical testing. The Company’s most advanced experimental molecule, PRTH-101, is in a Phase 1 clinical trial for the treatment of patients with advanced solid tumors. For more information visit incendiatx.com and LinkedIn.