Blue Earth Diagnostics is an established molecular imaging company on a growth trajectory to provide innovative, well differentiated diagnostics solutions, informing patients and driving future therapies in cancer. Formed in 2014, Blue Earth Diagnostics success is driven by our management expertise and agility, supported by our demonstrated track record of rapid development and commercialization of PET radiopharmaceuticals. Blue Earth Diagnostics’ clinical focus is exclusively in cancer.
Axumin® (fluciclovine (18F)) is our first approved and commercially available product. Axumin® is a novel molecular imaging agent approved in the United States and the European Union for use in PET imaging to detect and localize prostate cancer in men with diagnosis of biochemical recurrence. Blue Earth Diagnostics is also investigating fluciclovine (18F) for use in neuro-oncology because fluciclovine has the potential application in imaging cancers other than in prostate cancer.
The company’s pipeline includes innovative radiohybrid Prostate Specific Membrane Antigen (rhPSMA) targeted technology which is a clinical-stage, investigational class of theranostic compounds, with potential applications in both the imaging and treatment of prostate cancer.
Blue Earth Diagnostics’ strategy is to apply its knowledge and expertise to developing promising cancer radiopharmaceuticals for imaging and therapy.
Blue Earth Diagnostics is a subsidiary of Bracco Imaging S.p.A., a global leader in diagnostic imaging.
The Blue Earth Diagnostics story begins in 2014, when the company was formed in Oxford, UK by founder and current CEO, Dr Jonathan Allis. Jonathan and his team strongly believe in the potential of precision radiopharmaceuticals and established Blue Earth Diagnostics to bring these innovative technologies to clinicians and patients worldwide.
Our company is named after Blue Earth County in Minnesota, USA, where Sir Henry Wellcome, founder of the Wellcome Trust, spent his childhood. Sir Henry was one of the most fascinating individuals of his time. A businessman, collector and philanthropist, he was born in the American West but ended his days as a knight of the British Realm. He co-founded a multinational pharmaceutical company that funded pioneering medical research, and in his lifetime, scientists funded by Sir Henry made great breakthroughs into understanding how our bodies work. After his death, Sir Henry’s will provided for the creation of the Wellcome Trust.
Blue Earth Diagnostics’ founding investor was Syncona, a leading FTSE250 healthcare company focused on investing in and building global leaders in life science. Syncona is aligned with two of the UK’s premium charitable funders in life science, the Wellcome Trust and Cancer Research UK.
Blue Earth Diagnostics’ first commercially available product, the diagnostic PET molecular imaging agent fluciclovine (18F), was invented at Emory University in Atlanta, GA, USA. The Emory University patents were licensed to Nihon Medi-Physics (NMP, Japan), and then to GE Healthcare before licensing it to Blue Earth in 2014.
Blue Earth Diagnostics announces that the New Drug Application (NDA) filing for fluciclovine (18F) for the detection and localisation of suspected biochemical recurrence of prostate cancer has been accepted by the US Food and Drug Administration (FDA) for Priority Review.
An exclusive US commercial manufacturing and distribution agreement with Siemens PETNET Solutions is signed for fluciclovine (18F).
The company expands in 2016, opening a US headquarters in Burlington, MA. US FDA approval for Axumin® (fluciclovine F 18) for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence was received in May.
Blue Earth Diagnostics launches Axumin for US patients in June 2016.
In May 2017, the European Medicines Agency grants the marketing authorisation for Axumin® (fluciclovine (18F)) for use in PET imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment.
Expansion of the portfolio of products and technologies for cancer through exclusive licensing of a family of radiohybrid Prostate Specific Membrane Antigen-targeted agents (rhPSMA). These innovative molecules have potential applications in both the imaging and precision therapy of prostate cancer.
In April, rapid growth of the company requires a move to larger global headquarters in Oxford, which were officially opened by Chair of the Wellcome Trust, Baroness Manningham Buller.
In August, Bracco Imaging S.p.A announces the acquisition of Blue Earth Diagnostics as a subsidiary of Bracco Imaging. The combined business leverages Bracco’s diagnostics modalities, global competencies, portfolio and financial resources. Blue Earth Diagnostics continues to be led by our current leadership team and retains our well-established Blue Earth Diagnostics name. Our headquarters remain in Oxford, UK whilst maintaining a significant and operational presence across the US, based in Burlington, MA.