Alex Zimmerman and Alexander Lin Share Insights on the FDA Breakthrough Device Designation Received for Non-Invasive Virtual Biopsy Technology

Shots:

Alex Zimmerman talked about virtual biopsy technology using standard MRI scanners. The technology will allow doctors to understand brain imaging via chemical indicators more extensively
Alexander Lin spoke about the data on which the BDD was granted by the FDA and the usage of Magnetic Resonance Spectroscopy (MRS) by this software
BrainSpec is a comprehensive web-based software platform designed to make Magnetic Resonance Spectroscopy (MRS) technology accessible to clinicians and researchers

Smriti: Thank you for connecting with us. Can you please start by discussing your non-invasive virtual biopsy technology?
Alex Zimmerman: BrainSpec makes the virtual biopsy a reality by providing advanced processing and analysis of magnetic resonance spectroscopy data that can be acquired on standard MRI scanners. Instead of getting pictures of the brain, our software measures brain chemistry. As you can imagine, the chemistry of a brain tumor is very different from that of healthy tissue and so by visualizing these chemical changes, we can provide clinicians with a unique way of seeing into the brain without the need for surgery or radiation.

Smriti: Tell us how this software will emerge as an advanced tool for brain imaging technology.
Alexander Lin: While brain tumors have certain chemical changes, other neurological diseases have their own distinct patterns. Virtual biopsies allow measurement across a broad range of disorders and chemical changes. This includes brain cancer, Alzheimer’s disease, brain injury, metabolic disorders, multiple sclerosis, and psychiatric disorders to name a few.

Smriti: Can you talk about the data based on which FDA granted BDD to this biopsy technology?
Alexander Lin: BrainSpec software to measures 2-hydroxyglutarate, a chemical that is only produced by certain types of brain tumors which makes it a specific marker for cancer. The BDD is specific to detecting and measuring 2HG in glioma patients for whom biopsy is inadvisable (e.g., patients with brainstem lesions that are at high risk for biopsy). Dr. Lin, co-founder of BrainSpec, and Assistant Professor at Brigham and Women’s Hospital and Harvard Medical School have published studies using these methods and helped to develop the BrainSpec software based on his experience with patients.

Smriti: Discuss how this software will be easy to use and accessible for patients.

Alexander Lin: One of the initial challenges with MR Spectroscopy data is that in its native form, it is not intuitive to either patients or clinicians for that matter! We have spent considerable effort to visualize the data in a way that is easy to understand and is as simple to interpret as a blood test. Just like when you have a cholesterol test that tells you if your lipids are too high, the BrainSpec software will compare the patient data with an established reference range and provides a scale to tell you if your brain chemistry is within that reference range.

Smriti: Shed some light on the usage of Magnetic Resonance Spectroscopy (MRS) by this software for virtual biopsy.

Alexander Lin: There are several important use cases for MRS in just brain tumors alone. One situation is when there is a lesion in the brain which is in an area where the neurosurgeon is afraid to biopsy because there is a high chance of significant injury or even death such as near the brainstem. BrainSpec intends to non-invasively diagnose those tumors. The other situation is after the patient has been treated with either surgery or chemoradiotherapy and the clinician wants to monitor the patient. Obviously, you don’t want to continually biopsy the patient and because MR Spectroscopy doesn’t use any radiation or contact with the patient, it can be repeated over and over again with no harm to the patient. Many of the patients that have MR Spectroscopy scans are ones that are seen over years and multiple scans to check to see if there are any signs of recurrence which would show up in the brain chemistry.

Smriti: Brief us on how this Brain Spec software will be more reliable and effective than the other conventional methods to create a virtual biopsy using standard MRI scanners.

Alex Zimmerman: In addition to the improved visualization of the MR Spectroscopy data, BrainSpec combines cutting-edge software with front-end visualization to make the data simple and instinctive based on multiple iterations with clinicians and experts in the field. As winners of the Google Cloud Machine Learning competition, we utilize a linear combinations model-based post-processing method that represents the most accurate and reproducible methods for measuring MR spectroscopy.

Smriti: Are you planning to develop other non-invasive and radiation-free techniques?

Alex Zimmerman: While the virtual biopsy and MR spectroscopy in brain tumors are the initial focus, the use of BrainSpec across a broad range of neurological diseases such as Alzheimer’s disease, brain injury, metabolic disorders, multiple sclerosis, schizophrenia, bipolar disorder, epilepsy, and other diseases which have been shown to alter brain chemistry is in the development pipeline. With the potential as a platform application, BrainSpec may venture outside of the brain as the core technology can be applied to other tissues.

Source: Canva

About the Authors:

Alex Zimmerman

Alex Zimmerman is the CEO & Co-Founder at BrainSpec. She is a biomedical engineer and entrepreneur with a passion for using science and technology to improve patient care. Alex co-founded BrainSpec, a software platform that enables the accurate, non-invasive diagnosis of brain disorders using magnetic resonance spectroscopy. Alex earned a BS in mechanical engineering from Tufts University and an MS in biomedical engineering from Brown University. In the Harvard Business School MBA program, she received the R.F. Jasse Distinguished Award in Entrepreneurship and Leadership.

Alexander Lin

Alexander Lin is the Co-Founder at BrainSpec. He is also the director of the Center for Clinical Spectroscopy in the department of radiology at Brigham and Women’s Hospital and Assistant Professor of Radiology at Harvard Medical School. In 2016, with the support of the BWH iHub, he co-founded BrainSpec, Inc. a software platform that enables efficient, accurate, and non-invasive diagnosis of brain disorders by measuring brain chemistry. Dr. Lin is a graduate of the California Institute of Technology, where he completed his Masters's degree in Bioengineering and his doctoral degree in Biochemistry and Molecular Biophysics.