Blue Earth Diagnostics secures US FDA approval for Axumin injection

31 May 2016 (Last Updated May 31st, 2016 18:30)

UK-based molecular imaging diagnostics company, Blue Earth Diagnostics, has secured the US Food and Drug administration (FDA) approval for its Axumin (fluciclovine F 18) injection to detect prostrate cancer recurrence in men.

Prostrate

UK-based molecular imaging diagnostics company, Blue Earth Diagnostics, has secured the US Food and Drug administration (FDA) approval for its Axumin (fluciclovine F 18) injection to detect prostrate cancer recurrence in men.

Axumin is a new molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment.

Prostate cancer causes the second most cancer-related deaths in men. Primary prostate cancer can be successfully treated, however recurrence of the same cancer occurs in up to one-third of patients and is detected by a rise in PSA levels.

Axumin addresses the area where conventional imaging fails to detect the location and gravity of the recurrence by targetting the increased amino acid transport that occurs in many cancers, including prostate cancer.

Axumin injects a synthetic amino acid that is received by prostate cancer cells rather than surrounding normal tissues, and is labelled with the radioisotope F18 for PET imaging.

"The product will be convenient for patients and imaging facilities, as it can be made widely available and the entire imaging procedure can typically be completed in less than 30 minutes."

Emory University School of Medicine nuclear medicine and molecular imaging division director Radiology and Imaging Sciences associate professor and Georgia Research Alliance Distinguished Cancer Scientist David Schuster said: "An imaging agent with sufficient diagnostic performance to adequately detect and localise recurrent prostate cancer can provide referring physicians with actionable information to guide biopsy and inform management decisions for their patients.

"The fluciclovine molecule in Axumin was originally developed at Emory by Mark Goodman, Ph.D., and detects the upregulation of amino acid transport that occurs in prostate cancer and can potentially identify recurrent prostate cancer more reliably than conventional imaging techniques.

"The product will be convenient for patients and imaging facilities, as it can be made widely available and the entire imaging procedure can typically be completed in less than 30 minutes."

Blue Earth Diagnostics is exploring ways to apply the product to other cancer indications, such as glioma.


Image: Illustration depicting occurrence of prostrate cancer in man. Photo: courtesy of BruceBlaus.