FDA grants Cytotron Breakthrough Device Designation for breast, liver and pancreatic cancers

Share on facebook
Share on twitter
Share on linkedin
Share on email
Share on print

FDA granted Shreis Scalene Sciences Breakthrough Device Designation for the Cytotron, a CE-marked, whole-body therapeutic medical device.

The Center for Devices and Radiological Health granted the designation.

The company’s designation request stated that “The Cytotron is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of the breast, liver, and pancreas.”

Shreis, while actively pursuing collaborations for clinical trials in the current proposed indications for use, intend to also submit a request for Breakthrough designation in other solid tumors such as adult and pediatric brain tumors, lung cancer, and other life-limiting diseases.

YOU MAY BE INTERESTED IN

In April 2025, announcements from the two most influential biomedical agencies in the US, the FDA and the NIH, declared that both will seek to reduce and minimize animal-based testing and experimentation. These declarations sparked joy in some circles, and deep concern in others that was reflected in a 28% fall in the share price of Charles River Labs (NYSE: NYSE:CRL). 
Over the past three decades, cancer genetics has transformed precision oncology. Germline testing has advanced from single-gene Sanger sequencing to parallel sequencing of hundreds of genes, while tumor (somatic) testing has expanded with the rise of targeted therapies based on point mutations, copy number changes and other alterations. 

Never miss an issue!

Get alerts for our award-winning coverage in your inbox.

Login