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. See next page for more information.

Lung cancer screening represents a significant unmet need1

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 Fewer than 5% get Early stage detection can lead

for screening3 screened4 to potentially curative options5

Randomized trial results Lung cancer screening has been shown to reduce lung cancer deaths and all-cause mortality6 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 DELFI is collaborating with Johns Hopkins School of technologies, DELFI’s platform is: Medicine on novel liquid biopsy tests that demonstrate high performance for the early detection of cancer.

• More accessible across socioeconomic groups While legacy approaches look for alterations of DNA

• Easier to execute and distribute across geographies sequence, focal methylation patterns, or protein levels in narrow regions of the genome, DELFI uses

• Covers entire genome to comprehensively whole genome sequencing, and is not afected by identify cancer and its origin confounding conditions such as CHIP, medications,

• Achieving high sensitivity for early stage disease7 or inflammatory conditions. 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. NTo learn more, visit 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). DELFIDiagnostics.com

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 To learn more, visit history who currently smoke or who have quit within the past 15 years. FirstLooktest.com

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 1 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 1 the efciency 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 1 than it is for those with a Not Elevated result.

5.2X

An Investment in Health Systems and the Communities They Serve

DELFI developed the FirstLook Lung test to make low-dose CT scans more efcient for health systems and more efective for patients. FirstLook aligns with the CDC/HHS Healthy People 2030 Objectives, which highlight the importance of raising lung cancer 2 screening rates among eligible adults and reducing lung cancer deaths.

CDC: Centers for Disease Control and Prevention HHS: U.S. Department of Health and Human Services

Laboratory Information The FirstLook Lung test is a laboratory-developed test. It was developed and its performance characteristics determined by

FirstLook Seamlessly Integrates into Health System Workflows

Awareness & Education

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.

Provider Portal for Test Order & Support

Visit us online to learn more about the FirstLook Lung test. FirstLooktest.com

Blood Draw

Return of Results

Results Support

Validating Milestones

2019 DELFI Diagnostics Founded

2019 Groundbreaking study published in Nature1

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

First patient enrolled in prospective lung trial

2022 $225 million raised in Series B financing

Publications

Genome-wide cell-free DNA fragmentation in patients with cancer.

1. Cristiano S, Leal A, Phallen J, et al. Nature. 2019;570(7761):385-389.

Detection and characterization of lung cancer using cell-free DNA fragmentomes. 2. Mathios, D., Johansen, J.S., Cristiano, S. et al. Nat Commun. 12, 5060 (2021).

Backed by Top Investors

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.

800.589.2182

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 3,4,5 positive to true positive rate.

To Learn More Visit:

3.Cristiano S, et al. Nature. 2019;570(7761):385-389.
4.Mathios D, et al. Nature Commun. 2021;12(1):5060. 5.Bach P, et al. ISPOR 2023 (poster).