Molecular diagnostics company, Blue Earth Diagnostics and GE Healthcare have signed an agreement to manufacture the Positron Emission Tomography (PET) imaging product Axumin® in the UK.
Following receipt of marketing authorization for Axumin from the European Commission in May 2017, Blue Earth Diagnostics is working to build a network of authorized and approved manufacturing locations across Europe.
The agreement with GE Healthcare marks the first step towards full commercial availability of Axumin to PET imaging centres in the UK.
The company recently announced manufacturing and distribution agreements for Axumin in France, Germany, Ireland, Italy, Portugal and Spain.
Axumin is indicated in Europe for use in PET imaging to detect recurrence of prostate cancer in adult men with a suspected recurrence based on elevated prostate specific antigen (PSA) levels after primary curative treatment.
Prostate cancer is the most common cancer in the UK for men, with 46,690 new cases diagnosed each year. While most primary prostate cancer can be successfully treated, the disease recurs in up to one-third of patients.
In some patients, recurrent disease is detectable only by a rise in PSA levels, but often the location of the recurrence cannot consistently be located by conventional imaging, limiting treatment guidance.
Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.
Jonathan Allis, chief executive officer of Blue Earth Diagnostics said: “This agreement with GE Healthcare marks the first step towards full commercial availability of Axumin in the UK.
“Detection and localization of recurrent prostate cancer is a significant unmet medical need, and Blue Earth Diagnostics is committed to making Axumin accessible to clinicians and their patients across Europe.
“Today’s (2 October) announcement is another step towards that goal, and we look forward to working with the team at GE.”
Kevin O’Neill, general manager of core imaging for GE Healthcare Life Sciences, said: “We are thrilled to support Blue Earth Diagnostics in their mission to improve prostate cancer care for patients in the UK.
“We are very excited to contribute to this project with the expertise, quality and reliability of GE Healthcare’s PET production capabilities in the UK.”