# DELFI Diagnostics ### Next-Generation Liquid Biopsy Platform, Early Experience Program DELFI is developing a new class of liquid biopsy tests to aid early detection and monitoring 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, DELFI can detect these fragment patterns at a very low sequencing cost. DELFI’s first product is designed to enhance lung cancer screening. We are working with health systems to make this innovative test available to patients. #### Lung cancer screening represents a significant unmet need ## Lung Cancer ### Lung cancer is the #1 cause of cancer death ## Screening ### among men and women in the United States #### 15.1 million people eligible for screening Fewer than 5% get screened Early stage detection can lead to potentially curative options **Randomized trial results** **Lung cancer screening has been shown to reduce lung cancer deaths and all-cause mortality** Lung cancer mortality All-cause mortality National Lung Cancer Screening Trial benefit of 20% reduction of 6.7%. #### Increased Access, Fragmentomics Spurred Durable Advantages by Robust Science Compared to legacy liquid biopsy technologies, DELFI’s platform is: - **More accessible across socioeconomic groups** - **Easier to execute and distribute across geographies** - **Covers entire genome to comprehensively identify cancer and its origin** - **Achieving high sensitivity for early stage disease** 1. NLST Research Team. Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N Engl J Med 2011; 365:395-409. 2. NIH National Cancer Institute. Cancer Stat Facts: Common Cancer Sites. 3. Meza R, Jeon J, Toumazis I, et al. Evaluation of the benefits and harms of lung cancer screening with low-dose computed tomography: modeling study for the US Preventive Services Task Force. JAMA. 2021;325(10):988-997. doi:10.1001/jama.2021.1077 4. NIH National Cancer Institute. Cancer Stat Facts: Common Cancer Sites. 5. US Preventive Services Task Force. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021;325(10):962–970. 6. NLST Research Team. Reduced Lung-Cancer Mortality with Low-Dose Computed Tomographic Screening. N Engl J Med. 2011;365:395-409. 7. Mazzone, P.J., Bach, P.B., Carey, J., et al. Cancer Discovery. 10.1158 – 2159-8290. CD-24-0519. (2024). ## Indications for Use ## A New Area in Lung Health *The United States Preventive Services Task Force (USPSTF) recommends annual low-dose CT screening for lung cancer in adults aged 50-80 years who have a ≥20 pack-year smoking history who currently smoke or who have quit within the past 15 years.* Clinically Impactful Performance FirstLook Lung was validated in a prospective, case-control, observational study. The Key is High NPV In individuals with a Not Elevated result 998 out of 1000 will not have lung cancer detected on low-dose CT. 99.8% Negative Predictive Value. Reduces the Number Needed to Screen The NNS for an Elevated FirstLook lung result is 79. While the NNS for the USPSTF population is 143. Thus, improving the efficiency of a lung cancer screening program. Improves the Risk/Benefit Ratio of Lung Cancer Screening The likelihood a lung cancer is found by LDCT for individuals with an Elevated result is 5.2 times higher than it is for those with a Not Elevated result. An Investment in Health Systems and the Communities They Serve DELFI developed the FirstLook Lung test to make low-dose CT scans more efficient for health systems and more effective for patients. FirstLook aligns with the CDC/HHS Healthy People 2030 Objectives, which highlight the importance of raising lung cancer screening rates among eligible adults and reducing lung cancer deaths. Laboratory Information The FirstLook Lung test is a laboratory-developed test. It was developed and its performance characteristics determined by DELFI Diagnostics. It has not been cleared or approved by the FDA. The laboratory is regulated under the Clinical Laboratory Improvement Act (CLIA) as qualified to perform high complexity clinical tests. This test is used for clinical purposes. It should not be regarded as investigational or for research. Validating Milestones - 2019 DELFI Diagnostics Founded - 2019 Groundbreaking study published in Nature - 2020 FDA grants Breakthrough Device Designation - 2019 Licensed DELFI technology from Johns Hopkins School of Medicine - AUG 2022 Two issued patents on core technology - 2024 Monitoring Assay Available DELFI-Tumor Fraction assay (RUO) - 2023 CLIA/CAP Accredited - 2020 $100 million Series A financing - 2022 $225 million raised in Series B financing Publications 1. Genome-wide cell-free DNA fragmentation in patients with cancer. Cristiano S, Leal A, Phallen J, et al. Nature. 2019;570(7761):385-389. 2. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Mathios, D., Johansen, J.S., Cristiano, S. et al. Nat Commun. 12, 5060 (2021). Client Services: Non-invasive and convenient blood test for evaluation of those screen eligible who have not undergone LDCT for lung cancer screening and for those not adherent with follow-up screening. Easy to incorporate into routine practice. High sensitivity including for the earliest curable stages of cancer, reduces the number of LDCTs needed to screen to detect lung cancer and the LDCT false-positive to true positive rate.