Novel technology a step closer to enhancing breast cancer detection

MedTech News: Positive results from the independent review of the magnetic nanoparticle technology for breast cancer detection has been announced by clinical stage medical imaging company, Imagion Biosystems.

The independent reviews by a panel of expert breast cancer radiologists has corroborated the company’s previous assertion that the MagSense imaging agent provides new information for the radiologist not available through conventional methods, like ultrasound, and has the potential to aid in the clinical assessment of nodal metastasis in HER2 positive breast cancer and reduce the need to rely on invasive biopsies.

A research collaboration was established with Siemens Healthineers in Australia to assist with the optimisation of MRI protocols currently being used in the MagSense HER2 breast cancer study.

“The outcome of the independent review is welcome news,” stated Bob Proulx, CEO of Imagion Biosystems.

“We now have a clear indication that our MagSense magnetic nanoparticle technology could work with the existing medical imaging infrastructure to provide the clinical benefit to breast cancer patients we have been aiming for. This takes a lot of the technical risk out of the future and will significantly facilitate market entry by eliminating the need to design, make, sell, and support new machinery.”

Anatomical images through X-ray, ultrasound, MRI, CT scans and PET scans cannot differentiate benign from malignant lesions. MagSense Technology aims to transform how medical imaging can detect and diagnose cancer. It uses bio-safe magnetic nanoparticles to “tag” cancer cells and the targeted imaging agent provides molecular confirmation of the presence of cancer not just a suspicion.

Imagion Biosystems to advance early detection of breast cancer with biosafe imaging technology

Mr Proulx added “We will continue to refine our proprietary relaxometry technology but can now confidently shift our resources to developing our nanoparticles for use with MRI, a ubiquitous imaging modality used in hospitals and radiology clinics throughout the world. We believe this will be more attractive for strategic partners and more likely for us to achieve commercial success sooner.”

Since all MagSense targeted imaging agents use the same underlying magnetic nanoparticle technology, the company now plans to prioritise the development of its MagSense nanoparticle technology for use with mainstream clinical MRI scanners.

The company has already initiated the regulatory process with the US Food and Drug Administration (FDA) regarding bringing the HER2 Breast Cancer clinical studies to the US where there will be access to a larger number of sites and a more substantial patient population.

Whereas previously the FDA had designated the MagSense relaxometry technology as a medical device, recent US legislation has stipulated that any MRI contrast agent be regulated as drugs through the imaging group within the Centre for Drug Evaluation and Research (CDER).

The company does not expect the change to seek approval for its imaging agents for use with commercially available MRI scanners to significantly impact the time or cost associated with obtaining regulatory approvals.

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