Cancer diagnostic wins FDA approval

A new diagnostic tool to help doctors pinpoint exactly where in the body prostate cancer recurs has been granted approval by the US Food and Drug Administration (FDA).

Microscopy image of normal and cancerous human tissue samples.
Microscopy image of normal and cancerous human tissue samples.
Credit: Aamir Ahmed, Jane Pendjiky and Michael Millar, Wellcome Images

The tool, called Axumin™, was developed by Blue Earth Diagnostics Ltd, a subsidiary of Syncona LLP, the healthcare investment company founded by Wellcome. 

Prostate cancer is the second leading cause of cancer death in men in the USA. While most cases of the primary disease can be treated successfully, the cancer recurs in up to a third of patients. The recurrence of the disease is sometimes only detectable by a rise in prostate specific antigen (PSA) levels in the blood, without any indication of where the disease is, delaying detection and treatment. 

Axumin™ is a molecular tracer. When it is injected as part of a PET imaging scan, it enables doctors to detect and localise the cancer. Knowing the location and to what extent the cancer has recurred helps to determine the most appropriate method of treatment.

This is the first product approval for Syncona, which was formed by Wellcome in October 2012 to deliver impact to patients from world-class research.