Hawkeye Bio

What Hawkeye Bio does

Hawkeye Bio is a privately held medical technology company founded in 2019 that develops diagnostic tests for the early detection of cancer, infectious disease, and autoimmune disease. The company's core technology is a patented pristine graphene-based biosensor platform that detects protease enzyme activity through optical signaling mechanisms, distinguishing enzyme activity levels rather than mere enzyme quantity. This biosensor approach is positioned by management as simpler to operate than ELISA, more sensitive than PCR, and more cost-effective than next-generation sequencing.

The lead product, ProLung, is a blood test for lung cancer early detection that management reports achieves 95% sensitivity at Stage I and 99.8% negative predictive value. A separate LEAP blood test is being deployed across the VA community through a Johnson & Johnson Innovation award. An 18-sensor protease panel generates fluorescent signal fingerprints associated with lung cancer. The company has published clinical data in Nature Communications Medicine showing 90% Stage I detection at 82% specificity, and operates a CLIA-certified high-complexity laboratory in Torrance, California that supports the multi-country TEMPLAR clinical trial and offers SalivaDirect PCR testing under an EUA from the Yale School of Public Health.

Hawkeye Bio is headquartered in Los Angeles with a European headquarters in Dublin, Ireland (established November 2019), an R&D center within the Lundquist Institute in Torrance, California (opened February 2020), and JLABS incubator residency in Shanghai, China (opened June 2019). The company has a 1-10 employee footprint and is led by co-founder/CEO André de Fusco and co-founder/CSO Paul Dempsey, PhD, with consulting COO Richard Chernicoff and consulting CMO Paul Song, MD. In May 2024 the company pivoted toward an IVD kit commercialization strategy targeting healthcare systems in China and Europe, and in March 2026 it was granted U.S. Patent No. 12,461,102 covering the core biosensor platform. The company's revenue model is pre-commercial, with clinical lab services as a minor service line.

Name

Hawkeye Bio

Legal name

Hawkeye Bio, Inc.

Website

https://hawkeyebio.com

Company type

Private

Founded year

2019

Operating status

Operating

Headcount range

11–50 employees

Short description

Hawkeye Bio is a privately held medtech company developing a proprietary graphene-based biosensor platform for early detection of cancer, with lead products ProLung and LEAP blood tests for lung cancer screening and an IVD kit commercialization strategy.

Ownership category

akta.pro rank

Product category

In Vitro Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Analytical Laboratory Instrument Manufacturing (334516)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Laboratory Analytical Instruments (3826)

akta.pro industry

PRIMARYHLAGADAG

Proteomics & Biomarker Analytical Testing

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Laboratory Testing & Analytical Services

SECONDARYHLAFAMAB

Clinical Chemistry & Immunoassay Laboratories

Healthcare & Life Sciences/Healthcare Providers & Systems/Clinical Laboratories

SECONDARYHLAGAEAB

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Central Labs & Clinical Diagnostics Services (Trial Support)

SECONDARYHLAGAIAI

Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes)

Healthcare & Life Sciences/Life Science Tools & Services (CRO/CDMO/Lab Services)/Laboratory Equipment, Instruments & Consumables

Keywords

• In vitro diagnostics
• Lung cancer screening
• Protease biomarker detection
• Graphene biosensor platform
• Early cancer detection

Headquarters

HQ city

Torrance

HQ country

United States

HQ region

North America

Offices4 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. IVD Diagnostic Kits: Hawkeye Bio plans to commercialize its technology as in vitro diagnostic kits for lung cancer screening. The company is working to establish its protease-based detection kits as affordable and accessible screening options through collaborations in China and Europe.
2. Laboratory Testing Services: The company operates a CLIA-certified high-complexity lab in Torrance, California offering diagnostic testing services. The lab supports the company's TEMPLAR clinical trial and also offers SalivaDirect direct PCR testing under EUA from Yale School of Public Health.

Go-to-market motion2 records

Distribution channels2 records

Marketing channels4 records

Core offering

Hawkeye Bio develops and commercializes a proprietary pristine graphene biosensor platform that detects disease-associated protease enzyme activity through optical signaling. The platform powers diagnostic blood tests, principally the ProLung and LEAP blood tests for early lung cancer detection, and is being transitioned into in vitro diagnostic (IVD) kits for healthcare systems in China and Europe, supplemented by laboratory testing services delivered through the company's CLIA-certified lab in Torrance, California.

Product overview

Hawkeye Bio is a biotechnology company developing advanced biosensor technologies for early detection and monitoring of cancer, neurodegenerative disease, and inflammatory conditions. The company operates a platform-plus-products architecture centered on its proprietary graphene biosensor platform technology, which powers diagnostic products including ProLung (the lead blood test for lung cancer with 95% sensitivity at Stage I) and the LEAP Blood Test (deployed for VA community screening). The graphene biosensor platform is a nano-scale technology that detects protease enzyme activity levels in biological samples and is positioned as simpler than ELISA, more sensitive than PCR, and more cost-effective than NGS. The portfolio also includes an 18-sensor protease panel that generates fluorescent signals as a fingerprint for cancer detection, and SalivaDirect™ PCR testing services available through the company's CLIA-certified lab.

Differentiator

Problem solved

Functional benefit

Products and services

• ProLung Blood Test Blood test for early lung cancer detection that achieves 95% sensitivity at Stage I, 99.8% negative predictive value, and is 100% patient safe. Designed to stage-shift lung cancer detection from Stage III/IV to Stage I/II for at-risk individuals, including non-smokers and younger individuals excluded from national screening guidelines.
• LEAP Blood Test Blood test designed for early detection of lung cancer, specifically deployed for the VA and military community through the Innovations for Vets QuickFire Challenge program. Aims to provide accessible lung cancer screening for veterans.
• SalivaDirect PCR Testing Service Direct PCR testing service for infectious disease available through Hawkeye's CLIA-certified high-complexity laboratory in Torrance, California, offered under Emergency Use Authorization from Yale School of Public Health.

Quantifiable outcome

• 95% sensitivity at Stage I for lung cancer detection
• +3 more outcomes

Named customers4 records

Segments3 records

Ideal customer profiles1 record

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Five partnerships are on record, tiered core.

• Vejle Hospital (Denmark)coreStrategic or Co-development Partner · 28 January 2022Hawkeye's TEMPLAR trial was approved in Denmark for a 3,000 patient prospective clinical trial in partnership with Vejle Hospital. This represents a major clinical validation milestone for the company's lung cancer detection technology.
• Marmara University (Istanbul, Turkey)coreStrategic or Co-development Partner · 29 October 2021Hawkeye expanded TEMPLAR clinical trial recruitment to Marmara University in Istanbul, Turkey, extending the geographic reach of its clinical validation studies.
• University of Kansas Medical CentercoreStrategic or Co-development Partner · 4 April 2020Hawkeye expanded TEMPLAR clinical trial recruitment to University of Kansas Medical Center in Kansas City, Kansas, supporting the company's multi-site clinical validation program.
• Lundquist InstitutecoreStrategic or Co-development Partner · 29 February 2020Hawkeye opened its California R&D center located within the Lundquist Institute in Torrance, California, providing access to research facilities and potential collaboration opportunities.
• Johnson & Johnson Innovation (JLABS Shanghai)coreStrategic or Co-development Partner · 31 January 2019Hawkeye won the Johnson & Johnson Innovation QuickFire Challenge for Global Lung Cancer Initiative in January 2019. The award included a cash prize and residency in JLABS incubator in Shanghai, China (opening June 2019), providing access to J&J's innovation ecosystem and resources.

Scale indicators5 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• GRAIL: GRAIL develops blood-based multi-cancer early detection tests (e.g., Galleri), making it the most directly comparable early-stage cancer detection diagnostics company to Hawkeye Bio. Both target protease/biomarker-based blood tests for early cancer detection.
• Guardant Health: Guardant Health is a leading liquid biopsy and blood-based cancer detection company offering tests such as Guardant360 and Shield for cancer screening. It is highly comparable to Hawkeye Bio in target market (oncology diagnostics) and use of blood-based biomarker detection, though at vastly greater scale and with established FDA approvals.
• Exact Sciences: Exact Sciences commercializes Cologuard for colorectal cancer screening and is developing additional blood-based cancer detection tests. Comparable to Hawkeye Bio in its focus on non-invasive screening diagnostics for early-stage cancer detection.
• Freenome: Freenome is a multiomics blood-based early cancer detection company running large prospective clinical trials (e.g., PREEMPT CRC). Highly comparable in business model (early-detection blood test for cancer screening, multi-disease platform ambitions).
• Natera: Natera develops cell-free DNA and molecular diagnostic tests, including Signatera for cancer detection and various blood-based oncology assays. Comparable in blood-based cancer diagnostics and CLIA-based lab services.
• Biodesix: Biodesix is a lung cancer diagnostics company offering blood-based tests (e.g., Nodify Lung) for early lung cancer risk assessment and nodule management. Directly comparable to Hawkeye Bio's lung-cancer-specific blood test focus.
• Veracyte: Veracyte provides genomic diagnostics for cancer, including the Afirma thyroid test and the Percepta lung test for lung cancer. Comparable to Hawkeye Bio in lung cancer diagnostic focus and CLIA-based molecular diagnostics.
• Cardea Bio: Cardea Bio develops graphene-biosensor-based diagnostic chips, making it the closest technology peer to Hawkeye Bio's pristine graphene biosensor platform. Both leverage graphene biosensor technology for biomarker detection.
• Oncimmune Holdings: Oncimmune commercializes EarlyCDT, a blood-based autoantibody test for early lung cancer detection. Comparable to Hawkeye Bio's ProLung and LEAP tests as a blood-based lung cancer screening diagnostic.

Broad incumbents

• Bio-Rad Laboratories: Bio-Rad is an established life science tools and clinical diagnostics manufacturer offering ELISA-based and other immunoassay platforms. Comparable as a broader incumbent in the laboratory analytical instruments and immunoassay space that Hawkeye Bio claims its technology can outperform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/hawkeyebio
• LinkedInlinkedin.com/company/hawkeye-bio-inc

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles4 records

Funding overview

Funding rounds2 records

Investors1 record

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 Hawkeye Bio