Blue Earth Diagnostics was formed in 2014. The company’s founding investor is Syncona, an investment company that is aligned with two of the UK’s premium charitable funders in life science, the Wellcome Trust, original founder of Syncona’s life science division, and Cancer Research UK.
Blue Earth Diagnostics has established its global headquarters in Oxford, UK and licenced the PET imaging agent fluciclovine (18F) from GE Healthcare. The company’s founding CEO is Dr. Jonathan Allis PhD, a recognized expert with over thirty years’ industry experience in the development and commercialisation of nuclear medicine products.
The company is named after Blue Earth County in Minnesota, USA, where Sir Henry Wellcome, founder of the Wellcome Trust, spent his childhood years. Sir Henry Wellcome 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. In his lifetime, scientists funded by Wellcome 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’ first product, fluciclovine (18F), was invented at Emory University in Atlanta, Georgia USA. The resultant Emory University patents were licensed to Nihon Medi-Physics (NMP), a Japanese joint venture owned by Sumitomo and GE Healthcare. GE Healthcare licensed fluciclovine (18F) from NMP in 2008, before licensing it on to Blue Earth Diagnostics in 2014.
In 2016 Blue Earth Diagnostics established its US headquarters in Burlington, MA to provide sales, marketing and medical affairs support for the development and commercialization of fluciclovine F18 in the USA. The company also signed an exclusive US commercial manufacturing and distribution agreement with Siemens PETNET Solutions.
In May 2016, the US FDA approved Axumin® (fluciclovine (18F)) for use in PET imaging to detect and localize prostate cancer in men experiencing suspected biochemical recurrence.
In May 2017, the European Medicines Agency granted 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.
Blue Earth Diagnostics employed over 100 people globally at the end of 2018.