Policy & Regulation
Blue Earth Diagnostics' Axumin Added to EAU Guidelines for Imaging in Patients with Biochemical Recurrence in Prostate Cancer
18 April 2019 - - UK-based molecular imaging diagnostics company Blue Earth Diagnostics' Axumin (fluciclovine) has recently been added to the European Association of Urology 2019 Clinical Practice Guidelines in Oncology for Prostate Cancer, the company said.

The EAU PCa Guidelines assist clinicians in making informed decisions, taking into consideration the scientific data available and individual circumstances of patients.

These updated EAU PCa Guidelines state that "18F Fluciclovine has been approved in the US and Europe, and therefore is currently the only PCa-specific radiotracer widely commercially available."

Axumin is the first and only novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize recurrent prostate cancer.

Axumin is commercially available in Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Prostate cancer is a leading cause of cancer death in men in Europe, with around 450,000 new cases diagnosed each year.

The European Association of Urology is the leading authority within Europe on urological practice, research and education, with a mission to raise the level of urological care throughout Europe and beyond.

Blue Earth Diagnostics is a leading molecular imaging diagnostics company focused on the development and commercialization of novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need.

Formed in 2014, Blue Earth Diagnostics is led by recognized experts in the clinical development and commercialization of innovative nuclear medicine products.

The company's first approved and commercially available product is Axumin (fluciclovine F 18), a novel molecular imaging agent approved in the United States and European Union for use in PET imaging to detect and localize prostate cancer in men with a diagnosis of biochemical recurrence.

The company's pipeline includes Prostate Specific Membrane Antigen -targeted radiohybrid agents. rhPSMA is a clinical-stage, investigational class of theranostic compounds, with potential applications in both the imaging and treatment of prostate cancer. Blue Earth Diagnostics is backed by Syncona, an investment company listed on the London Stock Exchange (LON: SYNC).