COMPANY:

Delfi Diagnostics

"DELFI Diagnostics, Inc...announced the appointment of Dr. Amoolya Singh as Chief Technology Officer. Dr. Singh will spearhead DELFI Diagnostics' strategic technology roadmap, advancing the company's pioneering, AI-powered fragmentomics platform that unlocks unprecedented genomic insights at a transformative price. Dr. Singh joins a distinguished scientific leadership team whose innovations in early cancer detection and treatment monitoring are validated through groundbreaking clinical trials, global research partnerships, and seminal publications in leading medical journals."

"DELFI Diagnostics, Inc...has selected Lahey Hospital & Medical Center (LHMC), part of Massachusetts-based Beth Israel Lahey Health (BILH), to utilize its FirstLook Lung cancer screening test to help improve screening rates in the greater Boston area...Lahey will incorporate DELFI's blood-based lung cancer screening test in the primary care setting on patients eligible for lung cancer screening....In an independent validation, FirstLook Lung was shown to have very high sensitivity in a screening population, including detecting the earliest stages of the disease."

"PALO ALTO, Calif…announced today, the Florida Lung Health Coalition and DELFI Diagnostics, supported by RadNet, Inc..and the American Lung Association, are collaborating to launch a pioneering initiative to transform lung cancer screening and detection in Florida…This new program, announced ahead of Lung Cancer Awareness Month in November, aims to significantly boost early detection rates in Florida where lung cancer screening rates are at only 15.8%, according to the Centers for Disease Control and Prevention Behavioral Risk Factor Surveillance System. The initiative will be funded through grants and corporate sponsorships by the partners, and it brings together leading healthcare organizations to address the critical need for accessible and efficient lung cancer screening."

P3 | N=564 | CAIRO5 (NCT02162563) | "DELFI Diagnostics...is announcing the publication...in Nature Communications that demonstrates the effectiveness of cell-free DNA (cfDNA) fragmentomes as a means of assessing tumor burden for treatment response, monitoring, and clinical outcome prediction. cfDNA fragmentomes are tumor and mutation-independent, and the approach described in the paper (called DELFI-Tumor Fraction or 'DELFI-TF') requires only 800ul of plasma....The new paper further demonstrates the characteristics of DELFI-TF in two independent validation cohorts. 'DELFI-TF is a locked machine learning classifier validated in two independent cohorts of colorectal and lung cancer patients and can detect clinical outcomes earlier than imaging. This work demonstrates the potential of DELFI-TF to estimate tumor burden for accurate treatment-response monitoring and clinical outcome prediction.'"

"Allegheny Health Network (AHN) and DELFI Diagnostics, Inc...announced a collaboration to evaluate the effectiveness of DELFI Diagnostics' 'FirstLook' blood test to enhance lung cancer screening among western Pennsylvanians who are at risk for developing lung cancer – the leading cause of cancer-related deaths worldwide."

"Indigenous Pact..and DELFI Diagnostics...announced a partnership to utilize DELFI's FirstLook Lung to increase lung cancer screening and early detection in Tribal communities throughout the State of Washington...The collaboration to offer lung cancer screening with FirstLook's blood-based test will initiate in Washington and expand across Tribal Nations....On June 12-14, in San Diego, Indigenous Pact will host its inaugural Regional Tribal Summit. This summit will bring together Tribal leaders to discuss their communities' needs and how best to harness opportunities and address challenges. DELFI will participate in the event to further its understanding of how new technologies like the FirstLook Lung test can aid leaders in their goals to improve healthcare delivery across Indian Country."

"DELFI Diagnostics, Inc...announces the publication of groundbreaking data in the prestigious journal Cancer Discovery from the company's L101 study, 'Clinical validation of a cell-free DNA fragmentome assay for augmentation of lung cancer early detection'. The report details the performance and potential of DELFI's FirstLook Lung test. This milestone study, led by top researchers in the field, marks a significant advancement in aiding blood-based cancer detection."

"DELFI Diagnostics...announced an equity investment by the Merck Global Health Innovation Fund (GHIF), the corporate venture capital arm of Merck & Co., Inc, known as MSD outside the United States and Canada. The capital will accelerate and expand DELFI's development and commercialization of its cancer detection solutions. DELFI's fragmentomics technology applies artificial intelligence (AI) to whole-genome sequencing data to compare an individual's cell-free DNA (cfDNA) patterns and characteristics against populations with and without cancer."

"OSF HealthCare...and DELFI Diagnostics, Inc...today announced a collaboration to utilize DELFI's FirstLook Lung blood-based cancer screening test to help improve screening rates. DELFI's collaboration with OSF was recently highlighted by the Biden Cancer Moonshot to expand accessibility to lung cancer screening...The goal is to further increase screening among eligible OSF patients by incorporating the FirstLook Lung liquid biopsy test into the primary care setting. The test will be offered at 18 locations initially, with plans to make it OSF Ministry-wide within a year....The test works by evaluating patterns of DNA fragments in the blood that reveal the presence of lung cancer."

"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."