Device for non-invasive brain biopsies via blood draw nears market approval | Washington University School of Medicine in St. Louis

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FDA grants Breakthrough Device designation based on VashU technology

Courtesy of Hong Chen

A device that aims to allow neurosurgeons and other doctors to perform non-invasive blood biopsies on adults with brain tumors has received breakthrough device designation from the Food and Drug Administration (FDA). The device incorporates technology from Washington University in St. Louis and was developed by Cordance Medical Inc., a medical device company in Mountain View, California.

The designation aims to give patients and healthcare professionals timely access to new medical devices by speeding up the review process needed to bring the technology closer to market.

The FDA’s distinction applies to devices that have undergone rigorous review and show exceptional promise for improving the treatment or diagnosis of life-threatening or debilitating diseases. The technology was co-invented by Eric C. Leuthardt, MD, Shi Hui Huang Professor of Neurosurgery at the University of Washington School of Medicine, and Hong Chen, MD, Associate Professor of Biomedical Engineering at the University’s McKelvey School of Engineering and of Neurosurgery at the School of Medicine.

The University of Washington recently licensed the technology to Cordance Medical. Leuthardt and Chen serve as advisors and shareholders to Cordance Medical, which is involved in commercializing the technology.

The device, called NeuroAccess, is portable and noninvasive and allows doctors to avoid high-risk brain surgery to obtain blood-based liquid biopsies from patients with or suspected brain tumors. The device uses sonobiopsy, a technique that targets the blood-brain barrier, a protective, semi-permeable membrane that prevents harmful substances in the blood from contaminating sensitive tissue in the brain. The interaction of ultrasound and microbubbles causes a temporary opening of the blood-brain barrier so that RNA, DNA and proteins from the brain can diffuse into the blood.

The sonobiopsy approach is revolutionizing brain diagnostics, said Leuthardt, also a professor of biomedical engineering, mechanical engineering and neuroscience. Just as magnetic resonance imaging (MRI) transformed the way we look at the anatomy of the human brain, sonobiopsy will transform the way we examine the brain at the molecular level. Basically, they were doing a brain biopsy without the high risk of brain surgery.

Researchers published a study in September, in the journal NPJ Precision Oncology, that found sonobiopsy to be feasible and safe for use in humans.

The breakthrough designation is the success of a team spanning multiple disciplines ranging from medicine, engineering, genetics, neuroscience and entrepreneurship to bring this concept from a very basic science model to an ongoing clinical trial, Leuthardt said. This is a triumph of cooperation.

Said Chen, also a professor of radiation oncology and radiology: Sonobiopsy is poised to open the door to diagnosing brain diseases where surgical biopsies are often not an option. Technology presents new possibilities in the diagnosis of neurodevelopmental, neurodegenerative and psychiatric disorders.

Leuthardt is director and Chen is a member of the Division of Neurotechnology in the Department of Neurosurgery, which focuses on multidisciplinary research to create innovative engineering solutions that can be translated to patients with neurological diseases. The University of Washington holds a patent for the sonobiopsy technology.

About Washington University School of Medicine

WashU Medicine is a global leader in academic medicine, including biomedical research, patient care and educational programs with 2,800 faculty. Its National Institutes of Health (NIH) research funding portfolio is the third largest among US medical schools, has grown 52% over the past six years, and along with institutional investments, WashU Medicine commits more than $1 billion annually to basic and clinical research innovation and training. Its faculty practice is consistently among the top five in the nation, with more than 1,800 faculty physicians working at 65 locations who are also on the medical staff of Barnes-Jewish and St. Louis Children’s Hospital BJC HealthCare. WashU Medicine has a rich history in MD/Ph.D. training, recently committed $100 million in scholarships and curriculum renewal for its medical students, and is home to top training programs in every medical subspecialty, as well as physical therapy, occupational therapy, and audiology. and communication sciences.

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