Blue Earth Diagnostics

What Blue Earth Diagnostics does

Blue Earth Diagnostics is a UK-headquartered molecular imaging company that develops and commercializes PET radiopharmaceuticals for cancer diagnostics. Founded in 2014 in Oxford and operating as an indirect subsidiary of Bracco Imaging S.p.A. since August 2019, the company is focused exclusively on oncology imaging across prostate cancer, brain cancer, and multiple solid tumors. Its core technology platform centers on radiohybrid PSMA-targeted agents licensed exclusively worldwide from Scintomics, FAP-targeted imaging agents partnered with Philochem AG, and fluciclovine chemistry originally invented at Emory University. The commercial portfolio comprises two FDA-approved products: Axumin (fluciclovine F 18), approved in May 2016 for recurrent prostate cancer imaging and subsequently EMA-approved in May 2017; and POSLUMA (flotufolastat F 18), approved in May 2023 as the first radiohybrid PSMA-targeted PET imaging agent for prostate cancer and subsequently approved in South Korea and Taiwan through local marketing authorization holders.

The company's revenue model combines one-time product sales of approved imaging agents with licensing and royalty income from regional marketing authorization holders in Asia. Distribution relies on exclusive US manufacturing and supply through PETNET Solutions, a Siemens Healthineers subsidiary, plus European supply through Advanced Accelerator Applications (a Novartis company) and additional regional radiopharmacy distributors (Seibersdorf, IASON, M2i, Norsk medisinsk syklotronsenter). Reimbursement is supported by NCCN and EAU guideline inclusion for both Axumin and POSLUMA, and a CMS Transitional Pass-Through Payment Reimbursement Code for POSLUMA effective October 2023. The pipeline extends the franchise into brain metastases imaging (fluciclovine, Phase 3 REVELATE trial completed enrollment), FAP-targeted imaging for multiple solid tumors (Phase 1 complete), and — via a 2020 expansion of the Scintomics license and the 2021 formation of sister company Blue Earth Therapeutics — into therapeutic applications of the radiohybrid platform.

The customer base is healthcare professionals in nuclear medicine, radiology, urology, and oncology, reached through enterprise field sales and an event-driven go-to-market focused on major medical conferences (ASCO GU, SNMMI, ASTRO, EAU, AUA, RSNA, EANM). Named end customers include hospital systems and regional imaging centers (e.g., Northside Hospital Atlanta, Northern California PET Imaging Center), with commercial distribution extending across hundreds of US PET imaging sites via PETNET and additional European and Asia-Pacific territories via local partners. The company employs 101-250 staff across offices in Oxford (UK headquarters), Needham, MA (US headquarters opened April 2025), and Dublin (European marketing authorization holder).

Name

Blue Earth Diagnostics

Legal name

Blue Earth Diagnostics Limited

Website

https://blueearthdiagnostics.com

Company type

Private

Founded year

2014

Operating status

Operating

Headcount range

101–250 employees

Short description

Blue Earth Diagnostics is an Oxford-headquartered subsidiary of Bracco Imaging that develops and commercializes PET radiopharmaceuticals — Axumin and POSLUMA — for cancer diagnostics, serving nuclear medicine, oncology, and urology professionals in the US, Europe, and Asia-Pacific.

Ownership category

akta.pro rank

Product category

PET Radiopharmaceuticals

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Diagnostic Radiopharmaceuticals (SPECT/PET Tracers) (HLAIAGAA)

akta.pro secondary industries

Therapeutic Radiopharmaceuticals (Radioligand/Targeted Radionuclide Therapy) (HLAIAGAB), Nuclear Medicine Imaging Tracers & PET/SPECT Supply Chain (FDG, Ga-68, logistics/cold chain) (EUAKAIAE), Nuclear Medicine Imaging Agents & Kits (Cold Kits/Precursors) (HLAIAGAG)

Keywords

• PET radiopharmaceuticals
• Molecular imaging diagnostics
• Cancer imaging agents
• Radiolabeled pharmaceuticals
• Prostate cancer imaging

Headquarters

HQ city

Oxford

HQ country

United Kingdom

HQ region

Europe

Offices3 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

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

Revenue model

1. Axumin (fluciclovine F 18) Sales: Commercial sales of FDA-approved and EMA-approved PET imaging agent for recurrent prostate cancer detection. Marketed in the US, Europe, and UK through direct sales and distribution partnerships.
2. POSLUMA (flotufolastat F 18) Sales: Commercial sales of FDA-approved radiohybrid PSMA-targeted PET imaging agent for prostate cancer. Also approved in South Korea (Prostaseek) and Taiwan (POSLUMA) through local marketing authorization holders.
3. Licensing and Royalty Income: Revenue from licensing of proprietary technologies to regional partners. Marketing authorization holders in South Korea (DuChemBio) and Taiwan (Global Medical Solutions) pay royalties for flotufolastat F 18 distribution rights.

Go-to-market motion2 records

Distribution channels10 records

Marketing channels6 records

Core offering

Blue Earth Diagnostics develops, manufactures, and commercializes fluorine-18 labeled PET radiopharmaceuticals used in cancer imaging. Its commercially available products include Axumin (fluciclovine F 18) for detecting recurrent prostate cancer and POSLUMA (flotufolastat F 18) for prostate cancer imaging. The company also maintains a development pipeline including 18F-rhPSMA-7.3 and fibroblast activation protein (FAP)-targeted agents.

Product overview

Blue Earth Diagnostics is a molecular imaging company developing and commercialising PET radiopharmaceuticals for cancer diagnostics. Their portfolio includes two marketed products: Axumin (fluciclovine F 18), a PET imaging agent for recurrent prostate cancer approved in the US (2016), Europe (2017), and UK; and POSLUMA (flotufolastat F 18), a radiohybrid PSMA-targeted PET agent approved in the US (2023), South Korea (as Prostaseek), and Taiwan. The company maintains an active pipeline including 18F-rhPSMA-7.3 (completed Phase 3 SPOTLIGHT and LIGHTHOUSE trials) and FAP-targeted imaging technology (Phase 1 completed). Their clinical focus is exclusively on oncology, with products used in PET imaging to detect and guide treatment decisions for prostate cancer and other solid tumors.

Differentiator

Problem solved

Functional benefit

Brands

• Blue Earth Therapeutics: Sister company to Blue Earth Diagnostics, part of the Bracco family of companies, focused on advancement of next generation targeted radiotherapeutics to treat patients with cancer.

Products and services

• Axumin (fluciclovine F 18)

Quantifiable outcome

• 64% of patients had change in management following Axumin PET/CT scan (FALCON trial results, 2019)
• +3 more outcomes

Named customers3 records

Segments5 records

Ideal customer profiles1 record

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

13 partnerships are on record, tiered major, core and regional.

• Siemens HealthineersmajorTechnology or Integration · 8 May 2024Agreement to share POSLUMA (flotufolastat F 18) clinical data to support AI-based algorithms development. Builds on existing manufacturing partnership with PETNET Solutions, a Siemens Healthineers company.
• Sinotau Pharmaceutical GroupmajorChannel Partner/ Reseller/ Distributor · 17 October 2023Collaboration to bring flotufolastat (18F) injection, a prostate cancer PET diagnostic imaging agent, to China. Announced October 2023, expanding geographic reach to one of the largest pharmaceutical markets.
• Siemens HealthineersmajorTechnology or Integration · 18 October 2022Data-sharing agreement with Siemens Healthineers and University Hospital of Technical University of Munich for 18F-rhPSMA-7.3 clinical data to support AI-based algorithms development.
• Bracco Imaging S.p.A.coreStrategic or Co-development Partner · 1 August 2019Bracco Imaging, a global leader in diagnostic imaging operating in over 90 markets worldwide, acquired Blue Earth Diagnostics as an indirect subsidiary in August 2019. The acquisition leverages Bracco's diagnostics modalities, global competencies, portfolio, and financial resources while Blue Earth Diagnostics retains its established name and leadership team.
• IASON Sp. z o.o.regionalChannel Partner/ Reseller/ Distributor · 25 June 2018Appointed to manufacture and distribute Axumin (fluciclovine 18F) in Poland, expanding European market access.
• Scintomics GmbHcoreTechnology or Integration · 1 May 2018Blue Earth Diagnostics acquired exclusive worldwide rights to radiohybrid PSMA-targeted agents (rhPSMA) from Scintomics. In 2020, the partnership expanded to include exclusive worldwide rights to therapeutic applications of the novel radiohybrid technology. Scintomics CEO Jan Niclas Wester noted Blue Earth Diagnostics' remarkable speed in getting products to market.
• Seibersdorf LaboratoriesregionalChannel Partner/ Reseller/ Distributor · 10 October 2017Manufacturing and distribution agreements for Axumin (fluciclovine 18F) for PET imaging of recurrent prostate cancer in selected territories.
• Advanced Accelerator Applications (Novartis)majorChannel Partner/ Reseller/ Distributor · 1 October 2017European manufacturing and distribution agreements for Axumin. AAA, now part of Novartis following acquisition, provides radiopharmaceutical manufacturing capabilities across European markets.
• M2iregionalChannel Partner/ Reseller/ Distributor · 27 July 2017Appointed to manufacture and distribute Axumin in Ireland.
• PETNET Solutions (Siemens Healthineers)coreChannel Partner/ Reseller/ Distributor · 10 June 2016Exclusive US commercial manufacturing and distribution agreement for Axumin (fluciclovine F 18) signed in 2015, with commercial availability announced June 2016. New supply agreement signed in 2020 covering Axumin and investigational rhPSMA-7.3. Commercial availability of POSLUMA announced June 2023 through PETNET network.
• Norsk medisinsk syklotronsenter ASregionalChannel Partner/ Reseller/ Distributor · 24 March 2016Manufacturing and distribution partnership for fluciclovine (18F) in Norway.
• Philochem AGcoreTechnology or IntegrationPartnership for development of FAP (Fibroblast Activation Protein) targeting organic ligand for diagnostic imaging applications. Philochem completed Phase 1 clinical trial and Blue Earth Diagnostics assumed continued development and commercialization responsibilities. Prof. Dr. Dario Neri expressed excitement about results collected with the FAP imaging agent.
• Technical University of MunichcoreStrategic or Co-development PartnerResearch partnership for rhPSMA technology development. Professor Hans Jürgen Wester and Dr. Matthias Eiber from TUM's Department of Nuclear Medicine collaborated on radiohybrid technology. Data-sharing agreement established with Siemens Healthineers and TUM in 2022 for AI-based algorithm development using 18F-rhPSMA-7.3 clinical data.

Scale indicators5 records

Recent moves11 records

Expansion highlights6 records

Direct peers

• Curium: Curium is a global nuclear medicine company producing SPECT and PET radiopharmaceuticals, including PSMA-targeted agents. It competes head-to-head with Blue Earth Diagnostics in prostate cancer imaging and shares a similar radiopharmacy-led distribution model.
• Telix Pharmaceuticals: Telix develops and commercializes radiopharmaceuticals including Illuccix (Ga-68 PSMA-11) for prostate cancer imaging. It directly competes with Blue Earth Diagnostics' Axumin and POSLUMA in the prostate cancer PET imaging market and pursues a similar theranostic strategy.
• Lantheus Holdings: Lantheus is a direct competitor in PSMA-targeted PET imaging, marketing Pylarify (piflufolastat F 18) for prostate cancer. It is a comparable radiopharmaceutical/diagnostic imaging company with overlapping product, customer base, and commercial model in oncology imaging.

Broad incumbents

• Bracco Imaging: Bracco Imaging is the parent company of Blue Earth Diagnostics and a global leader in diagnostic imaging with operations in over 90 markets. It is comparable as a peer through its imaging agent portfolio (e.g., contrast media) and as the parent providing commercialization infrastructure.
• GE HealthCare: GE HealthCare is a broad incumbent in diagnostic imaging with PET/CT scanners and historically operated a radiopharmaceutical business from which Blue Earth Diagnostics' technology was originally licensed. It is also a major competitor/partner via its PETNET Solutions radiopharmacy network.
• Siemens Healthineers: Siemens Healthineers operates the PETNET Solutions radiopharmacy network that distributes Blue Earth Diagnostics' products in the US. It is a broad incumbent in imaging equipment and infrastructure (PET/CT, SPECT), with AI partnerships with Blue Earth Diagnostics for imaging algorithm development.
• Novartis (Advanced Accelerator Applications): Novartis owns AAA, a major radiopharmaceutical company offering PSMA and other nuclear medicine products (e.g., Lutathera, Pluvicto). AAA is also Blue Earth Diagnostics' European distribution partner for Axumin, making it both a partner and competitor across diagnostic and therapeutic nuclear medicine.

Emerging players

• Blue Earth Therapeutics: Blue Earth Therapeutics is the sister company to Blue Earth Diagnostics, also owned by Bracco, focused on therapeutic applications of the radiohybrid platform. It is comparable as an emerging player in radioligand therapy leveraging shared IP from the Scintomics partnership.
• Philochem AG: Philochem AG is a Swiss biotechnology company developing FAP-targeted radioligands. It is a partner to Blue Earth Diagnostics on FAP imaging agents and is comparable as an emerging player in the same targeting-modality space.
• Scintomics GmbH: Scintomics is the licensor of rhPSMA technology to Blue Earth Diagnostics and develops radiohybrid PSMA agents. It is comparable as an emerging radiopharmaceutical developer whose IP forms the basis of Blue Earth Diagnostics' flagship platform.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/5118298

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds1 record

Investors1 record

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M&A

Investments

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

Frequently asked questions about Blue Earth Diagnostics