COMPANY:

Delfi Diagnostics

"City of Hope...and DELFI Diagnostics...today announced a collaboration to utilize DELFI's FirstLook Lung, a blood-based lung cancer screening test, in a City of Hope clinical study to help improve screening rates in underserved communities in Los Angeles County. The test will be offered free of charge to eligible trial participants...Funded by a Discovery Boost grant from the American Cancer Society, awarded to Dan Raz...and the trial's principal investigator, the study that will evaluate use of the FirstLook Lung test to improve lung cancer screening rates in disadvantaged communities in the Los Angeles area. DELFI will make its liquid biopsy screening test, which will be submitted to the Food and Drug Administration for approval, available at various study locations, including City of Hope Antelope Valley...and ParkTree Community Health Center..."

"DELFI Diagnostics, Inc...today announced multiple upcoming poster and oral presentations at the American Association for Cancer Research (AACR) Annual Meeting, taking place in San Diego, California, from April 5-10, 2024. DELFI and independent researchers will highlight the performance of the company's next-generation, fragmentomics-based liquid biopsy platform to help detect early cancer and monitor treatment response."

"DELFI Diagnostics, Inc...announced availability of the company's fragmentome-based research use only (RUO) cancer monitoring assay. The DELFI-Tumor Fraction (DELFI-TF) assay is a highly sensitive, inexpensive means of noninvasive measurement of tumor burden and assessing treatment response and resistance in patients with advanced cancer."

"DELFI Diagnostics, Inc...announced support for the recently introduced Lung Cancer Screening and Prevention Act (H.R. 6693)...The proposed legislation would grant the Centers for Medicare & Medicaid Services (CMS) the authority to review U.S. Food and Drug Administration (FDA) approved or cleared new lung cancer screening tests as preventive services under the Agency's existing standards for coverage."

"DELFI Diagnostics, Inc...announced...the initial commercial introduction of FirstLook Lung. FirstLook is a blood test that offers a convenient, accurate and personalized result by determining the likelihood of detecting lung cancer through low-dose CT (LDCT), with a negative predictive value (NPV) of 99.7 percent."

"DELFI Diagnostics, Inc...announced...that the company will participate in multiple sessions at the HLTH 2023 conference in Las Vegas, Nevada, and the CHEST 2023 Annual Meeting in Honolulu, Hawai'i, both taking place October 8-11, 2023...An oral presentation at CHEST will highlight new data from the DELFI-L101 Study, 'DNA Evaluation of Fragments for Early Interception - Lung Cancer Training Study,' a prospective, multicenter, case-control study among individuals eligible for lung cancer screening to train and independently validate the blood-based test for early cancer detection."

"DELFI Diagnostics...has exclusively licensed a new, highly accurate method for identifying somatic genomic alterations in cell-free DNA (cfDNA) known as GEMINI, or GEnome-wide Mutational Incidence for Non Invasive detection of cancer....In a study published today in Nature Genetics, researchers showed that GEMINI, combined with the approach used by DELFI Diagnostics, could successfully identify early stage lung cancers – those cancers that are most critical to detect to change patient outcome."

"DELFI Diagnostics, Inc...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."

"Delfi Diagnostics, Inc...will present multiple oral and poster presentations showcasing the performance of its next-generation liquid biopsy platform at the American Association for Cancer Research's 2023 annual meeting next month...The presentations from Delfi and other independent researchers using the DELFI platform will provide updates on Delfi's lung cancer screening clinical trials, describe the DELFI platform's ability to detect early stage ovarian cancer, and detail how it performs in monitoring the progress of metastatic colorectal cancer patients on chemotherapy."

"Positive liver cancer detection data published in Cancer Discovery demonstrates the promise of Delfi Diagnostics' high-performance, accessible liquid biopsy platform in a new tumor type. Delfi had previously announced that it is developing a low-cost, highly sensitive blood test for lung cancer screening. The new findings, which will also be presented in Austin, Texas at AACR's Special Conference on Precision Prevention, Early Detection and Interception of Cancer, show how Delfi's platform could be applied in a second clinical context."

"Researchers using the DELFI platform, a technology for a new class of high performance, accessible liquid biopsy tests being commercialized by Delfi Diagnostics, Inc., will present new data demonstrating its ability to accurately detect liver cancer in high risk and average risk individuals at The Liver Meeting 2022, the annual meeting of the American Association for the Study of Liver Disease."

"Delfi Diagnostics...has been selected as the liquid lung cancer biopsy partner in Europe's multi-national, randomized, prospective lung cancer screening trial known as 4-IN-THE-LUNG-RUN, or 4ITLR...Through 4ITLR, European investigators are studying how often – every year, or every other year – individuals should get screened if their initial CT scan is negative. Delfi's technology is paired to the study objectives by measuring whether Delfi can identify individuals in Europe's screen-eligible population who are most likely to benefit from a CT scan."

"Delfi Diagnostics, Inc...announced a Series B funding of $225 million...This funding will support the continued development and commercialization of high-quality and accessible blood tests for single cancer early detection, multi-cancer early detection, and treatment monitoring."

"Delfi Diagnostics...will present updates at the 2022 annual meeting of the American Society for Clinical Oncology (ASCO) in Chicago June 3-7 describing multiple applications for its next-generation liquid biopsy platform...Delfi will present a trial-in-progress update on DELFI-L101, a prospective, case-control study to train and test classifiers for lung cancer detection."

"Delfi Diagnostics...has entered into a broad research agreement with Memorial Sloan Kettering Cancer Center's Biomarker Development Program...The agreement creates a framework for Delfi and MSK researchers to work together on a range of projects studying Delfi's liquid biopsy platform, advancing their shared mission of developing high performing cancer testing."

"Delfi Diagnostics...has enrolled the first participants in the CASCADE-LUNG study. CASCADE-LUNG is a prospective, multi-center trial that will enroll up to 15,000 participants at the time of their low dose CT (LDCT) lung cancer screening and will add to the clinical validation of Delfi's liquid biopsy test for lung cancer detection."

"Delfi Diagnostics...will present new findings from its fragmentomics-based platform at the American Association for Cancer Research (AACR) 2022 Annual Meeting....Delfi Founder and CEO Victor Velculescu was recognized by AACR for his stellar contributions involving the discovery of genomic alterations in cancer cells and for developing non-invasive cancer detection technologies."