Delfi Diagnostics

What Delfi Diagnostics does

Delfi Diagnostics is a precision oncology company founded in 2019 and headquartered in Palo Alto, California with CLIA-certified laboratory operations and an additional office in Baltimore, Maryland. The company has developed a proprietary fragmentomics platform that uses whole-genome sequencing and machine learning to analyze genome-wide cell-free DNA (cfDNA) fragmentation patterns in blood, detecting distinctive signatures left by cancer cells whose abnormal DNA packaging differs from healthy cells. The platform was first published in Nature in 2019 and has since been validated across multiple cancer types in peer-reviewed journals.

Delfi commercializes two products built on this platform. FirstLook Lung, launched in October 2023, is a laboratory-developed blood test for lung cancer screening in adults meeting USPSTF eligibility criteria (ages 50-80, 20+ pack-year smoking history); it reports a 99.8% negative predictive value and is integrated into Epic EHR workflows at partner health systems. DELFI-TF Treatment Monitoring, launched in February 2024, is a plasma-based tumor-agnostic assay sold as a research service to pharmaceutical companies conducting oncology clinical trials, with adoption reported at 25% of the top 20 pharma companies. The company has raised over $325 million across a $100 million Series A (OrbiMed, January 2021) and a $225 million Series B (DFJ Growth, July 2022), plus additional equity from Merck Global Health Innovation Fund and a reported December 2025 financing event; reported 2024 valuation was approximately $750 million.

The company's go-to-market operates through enterprise field sales targeting US health systems for FirstLook Lung (with named partnerships including Hackensack Meridian Health, Allegheny Health Network, OSF Healthcare, City of Hope, and Lahey Hospital & Medical Center) and direct sales to pharmaceutical clinical development teams for DELFI-TF. Pricing is not publicly disclosed; FirstLook Lung is currently not reimbursed by insurance and patients may use FSA/HSA accounts, while DELFI-TF pricing is study-specific. The company is CLIA-certified, CAP-accredited, ISO 27001 and ISO 13485 certified, and in May 2026 received NYSDOH Clinical Laboratory Permit authorization, completing nationwide coverage across all 50 US states.

Name

Delfi Diagnostics

Legal name

DELFI Diagnostics, Inc.

Website

https://delfidiagnostics.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

101–250 employees

Short description

Delfi Diagnostics is a precision oncology company using AI-powered fragmentomics analysis of cell-free DNA in blood to enable early cancer detection and treatment monitoring. It sells FirstLook Lung, a laboratory-developed lung cancer screening test to US health systems, and DELFI-TF Treatment Monitoring to pharmaceutical companies for oncology clinical trials.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG), Liquid Biopsy Biomarkers (ctDNA/ctRNA/CTCs/exosomes) (HLAAAMAH), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Liquid biopsy tests
• Cancer screening diagnostics
• Cell-free DNA analysis
• Fragmentomics platform
• Treatment monitoring assays

Headquarters

HQ city

Palo Alto

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Software

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. FirstLook Lung Laboratory-Developed Test: Revenue from laboratory-developed test (LDT) services for lung cancer screening sold to health systems, healthcare providers, and potentially patients directly. Test is currently not FDA-cleared or reimbursed but is commercially available. Patients may use FSA/HSA accounts for payment.
2. DELFI-TF Research Service: Treatment monitoring services sold to pharmaceutical companies conducting oncology clinical trials. Adopted by 25% of top 20 pharmaceutical companies since launch in February 2024. Provides cost-effective monitoring compared to traditional ctDNA approaches with rapid turnaround times.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels8 records

Core offering

DELFI Diagnostics develops and commercializes blood-based liquid biopsy tests for early cancer detection and treatment monitoring. Its core commercial offerings are FirstLook Lung, a blood-based lung cancer screening laboratory-developed test for USPSTF-eligible adults, and DELFI-TF, a plasma-based tumor-agnostic assay for monitoring cancer treatment response in pharmaceutical clinical trials. Both products are powered by the company's proprietary fragmentomics platform, which uses AI and whole-genome sequencing to analyze cell-free DNA fragmentation patterns.

Product overview

DELFI Diagnostics operates as a precision oncology company offering a platform-plus-products architecture built on its proprietary fragmentomics technology. The portfolio consists of two commercial products: FirstLook Lung, a blood-based lung cancer screening test launched in October 2023 for adults meeting USPSTF eligibility criteria; and DELFI-TF Treatment Monitoring, a research service launched in February 2024 for pharmaceutical companies to monitor cancer treatment response in clinical trials. Both products are powered by the underlying Fragmentomics Platform, which uses AI and whole-genome sequencing to analyze cell-free DNA fragmentation patterns across millions of genomic data points.

Differentiator

Problem solved

Functional benefit

Brands

• FirstLook Lung: Blood-based lung cancer screening test using AI and whole-genome sequencing to analyze cell-free DNA fragments for early cancer detection in USPSTF-eligible individuals.
• DELFI-TF

Products and services

• FirstLook Lung A blood-based laboratory-developed test that uses AI and whole-genome sequencing to analyze cell-free DNA fragmentation patterns for lung cancer screening. Designed for adults aged 50-80 with a 20+ pack-year smoking history meeting USPSTF eligibility, it provides binary Elevated/Not Elevated results with 99.8% negative predictive value to help determine likelihood of detecting lung cancer on low-dose CT. Sold to health systems, healthcare providers, and provider networks.
• DELFI-TF Treatment Monitoring A plasma-based, tumor-agnostic assay that measures circulating tumor DNA through cfDNA fragmentation analysis to monitor cancer treatment response. Requires only 800µl of plasma with 99% success rate and delivers results in as few as 10 business days. Offered as a research service to pharmaceutical companies conducting Phase 1-2 oncology clinical trials.

Quantifiable outcome

• 99.8% Negative Predictive Value (NPV) for FirstLook Lung test, meaning 998 out of 1000 people with Not Elevated result will not have lung cancer detected on LDCT.
• +4 more outcomes

Named customers9 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability5 records

Feature5 records

Partnerships

Ten partnerships are on record, tiered core and minor.

• Hackensack Meridian HealthcoreStrategic or Co-development Partner · 1 December 2025Healthcare improvement partnership to evaluate whether FirstLook Lung blood test can improve adherence to annual LDCT scans for lung cancer screening among high-risk individuals. Funded by a Healthcare Improvement grant from Eli Lilly and Company. Represents a forward-thinking approach to addressing persistent public health challenges in cancer prevention.
• Incendia TherapeuticscoreStrategic or Co-development Partner · 28 October 2024DELFI working with Incendia Therapeutics to employ advanced treatment monitoring test (DELFI-TF) in a Phase 1 clinical trial for oncology drug development.
• Florida Lung Health CoalitionminorGTM or Marketing Partner · 22 October 2024Coalition partnership with support from DELFI Diagnostics, RadNet, Inc., and The American Lung Association to launch a revolutionary lung cancer screening program focused on early detection in Florida.
• Indigenous PactcoreStrategic or Co-development Partner · 11 June 2024Partnership to enhance lung cancer screening in tribal communities, aiming to address health equity gaps and improve access to early cancer detection for indigenous populations.
• Allegheny Health NetworkcoreStrategic or Co-development PartnerPilot program exploring FirstLook Lung to enhance lung cancer detection. Dr. Ali Zaidi and colleagues at AHN are leading charge to transform lung cancer detection through innovative screening approaches.
• OSF HealthcarecoreStrategic or Co-development PartnerCollaboration to improve lung cancer screening rates. OSF Healthcare Cancer Institute has implemented FirstLook Lung and features nurse navigator programs to support patient engagement.
• City of HopecoreStrategic or Co-development PartnerCollaboration to improve lung cancer screening in underserved areas of Los Angeles, focusing on populations with limited access to traditional screening methods.
• Lahey Hospital & Medical CentercoreStrategic or Co-development PartnerSelected to administer the new FirstLook Lung lung cancer screening test to patients in the Boston area.
• University of Iowa College of PharmacyminorStrategic or Co-development PartnerCommunity pharmacy-based lung cancer screening initiative (CHAMP) supported by a grant from Lilly, exploring novel pharmacy-based access points for screening in Iowa.
• 4-IN-THE-LUNG-RUNcoreStrategic or Co-development PartnerDELFI selected as the liquid biopsy partner for large-scale European lung cancer screening study, validating technology in international context.

Scale indicators7 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Guardant Health: Guardant Health is a leading liquid biopsy company offering the FDA-approved Shield blood test for colorectal cancer screening and Guardant360 for tumor profiling. Direct competitor to DELFI in cfDNA-based cancer detection and MRD/therapy monitoring, with overlapping pharma service and health system channels.
• GRAIL: GRAIL developed the Galleri multi-cancer early-detection test using methylation-based cfDNA analysis. Competes with DELFI in blood-based multi-cancer screening and shares the same health system and self-pay go-to-market motion. Multiple DELFI executives were previously in senior roles at GRAIL.
• Exact Sciences: Exact Sciences commercializes Cologuard for CRC screening and Oncotype DX for cancer treatment decisions. Direct competitor in stool/blood-based cancer screening with established reimbursement, broad physician adoption, and a comparable platform-plus-pipeline strategy.
• Natera: Natera's Signatera is a tumor-informed MRD and treatment monitoring assay used widely in oncology clinical trials and patient monitoring. Direct competitor to DELFI-TF in pharma research services and MRD use cases, with comparable turnaround and plasma requirements.
• Freenome: Freenome is developing a blood-based multi-omics screening test (colorectal cancer lead indication) using cfDNA and protein biomarkers. Closely comparable to DELFI's platform-plus-indication approach, with a similar enterprise health system commercial strategy.

Broad incumbents

• Foundation Medicine: Foundation Medicine (a Roche subsidiary) provides comprehensive genomic profiling of solid tumors (FoundationOne CDx, FoundationOne Liquid CDx). Overlaps with DELFI in tumor profiling and pharma companion diagnostic services, but is broader and deeper in tissue-based testing.
• Roche Diagnostics: Roche Diagnostics is the global leader in clinical diagnostics, with a broad oncology portfolio including tissue and liquid biopsy, immunohistochemistry, and digital pathology. Adjacent incumbent with the scale and channel relationships that DELFI is building toward.
• NeoGenomics: NeoGenomics is a clinical oncology testing services company offering tissue, blood, and pharma research services. Overlaps with DELFI in oncology lab services and pharma clinical trial support, though its core is solid tumor profiling rather than screening.

Emerging players

• Personalis: Personalis offers NeXT Personal, a tumor-informed MRD and treatment monitoring assay using whole-genome sequencing. Direct overlap with DELFI-TF in pharma research services, with comparable WGS-based methodology but a narrower commercial footprint.

Regional players

• Burning Rock Biotech: Burning Rock Biotech is a China-based liquid biopsy company focused on NGS-based cancer therapy selection and MRD. Comparable technology stack and pharma services, but primarily serves the China market and does not directly compete with DELFI in the US.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights8 records

Customer concentration

• YouTubeyoutube.com/channel/UCv7e-20ef3HAJ4urkQ3porw
• LinkedInlinkedin.com/company/delfi-diagnostics

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds4 records

Investors20 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Delfi Diagnostics