Breast cancer diagnostic tool uses non-radioactive tracer
11 April 2013
A device that detects the spread of breast cancer without resort to radiation, allowing physicians to better plan intervention, is extending its market reach.
The device, co-developed by researchers at the University of Houston (UH) and University College London (UCL), is now a step closer to clinical trials in the US.
'SentiMag' is a novel intraoperative probe that enables surgeons to more effectively locate the sentinel lymph node – the first lymph node to which a tumour’s metastasising cancer cells drain.
The highly sensitive instrument and its associated Sienna+ tracer combine nanotechnology and advanced magnetic sensors to remove the need for radiation, speeding up the process and putting the detection of the sentinel lymph node directly in the hands of surgeons.
Co-developed by Professor Audrius Brazdeikis at UH, and colleagues at University College London (UCL), the device has been in use for more than a year in Europe and will now be distributed in the Middle East and Africa. Brazdeikis says approval for use in the US is not far behind.
This most recent development of distribution beyond Europe is the result of an agreement signed between Sysmex Europe GmbH, a manufacturer of clinical diagnostic systems, and Endomagnetics, a UH spinoff medical devices company.
Brazdeikis formed Endomagnetics with physics professor Quentin Pankhurst and systems engineer Simon Hattersley from UCL to bring their technology to the marketplace.
“The most rewarding aspect in this adventure has been taking our original idea and seeing it through to market introduction,” Brazdeikis said. “The biggest challenge wasn’t the technology or research or science, but actually developing collaborations across the science and business interface to make this commercialisation happen.”
Current protocol for locating the sentinel node involves injecting a radioactive isotope several hours before surgery, followed by the surgeon using a highly directional Geiger counter, called a gamma probe, in the operating room to locate the lymph node with the highest radioactivity.
Endomagnetics' SentiMag uses a detection system based on magnetics rather than radiation, with the radioactive tracer being replaced by the magnetic nanoparticle tracer and the handheld magnetic sensor replacing the gamma probe.
“This new method requires a surgeon to simply inject the area around a tumour with the Sienna+ nanoparticle, wait 30 minutes for the tracer to accumulate in the lymph nodes and then scan the area of interest using the SentiMag probe to locate the sentinel nodes,” Brazdeikis explains.
“In contrast to the radioactive tracer, a typical magnetic tracer has a shelf life of many months. There are no staff safety issues or disposal of radioactive waste, which lifts regulatory burdens. It also reduces overall cost for the hospital by improving surgery scheduling and, therefore, is more accessible to all patients.”
Initially funded by the UK-Texas Bioscience Initiative, the SentiMag system is currently in use in eight European Union countries – the United Kingdom, Germany, Poland, France, Italy, Belgium, Holland and Switzerland.
Sysmex being granted the exclusive right to provide sales and support for this revolutionary system across the European, Middle Eastern and African regions will provide a strong platform for further investment and growth.
This is Endomagnetics’ first multi-region agreement, and it promises to extend widely the clinical use of the company’s technology.
“We are extremely pleased with initial customer feedback,” said Eric Mayes, CEO of Endomagnetics. “Partnering with a group as strong as Sysmex gives us the geographic scope and customer support we need to really make an impact.”