FDA awards funding to Perspectum and physicians at Massachusetts General Hospital to accelerate development of imaging biomarkers as drug development tools in liver disease
- December 14, 2020
Dallas, Texas, December 14, 2020 - The Food and Drug Administration (FDA) Center for Drug Evaluation and Research has granted Perspectum funding to accelerate the qualification of their proprietary imaging biomarker, cT1, as a drug development tool for liver disease. The study will be run at Massachusetts General Hospital.
An estimated 30 percent of adults in the United States have fatty liver disease, which in its progressive form (non-alcoholic steatohepatitis; NASH), can lead to liver cancer or permanent scarring damage called cirrhosis. Despite the increasing focus on the development of NASH treatments from the pharmaceutical industry, there is still an unmet need for non-invasive, quantitative diagnostics for the disease. Liver biopsy is currently the gold standard for diagnosis and monitoring of NASH but it is an invasive and expensive procedure for patients.
Without better diagnostic tools, many patients will not gain access to therapeutics for years to come. The award is a testament to the FDA’s recognition of the value of imaging biomarkers measured by LiverMultiScan® to non-invasively evaluate and monitor NASH. These imaging biomarkers are measured using LiverMultiScan®, a multiparametric MRI-based technology shows correlates of liver fat, iron and fibroinflammatory disease in the liver. The scan has received FDA clearance for use in routine clinical care.
Kathleen Corey, Director of the Massachusetts General Hospital Fatty Liver Clinic, said of the study “We are pleased to support this research that will accelerate the availability of non-invasive tools to assess and monitor patients with fatty liver disease.”
“Non-invasive tests are critical for diagnosing and tracking the progression of liver disease. These tests are highly repeatable and can provide more information than biopsy since it assesses changes throughout the whole liver instead of a small amount,” added Mukesh Harisinghani, Professor of Radiology at Harvard Medical School and Director of Abdominal MRI at Massachusetts General Hospital.
"As a patient who has experienced liver biopsy and as an advocate representing the interests of liver patients, I cannot overstate the importance of developments in non-invasive testing for NASH and other liver diseases. The Global Liver Institute encourages initiatives to support research in this vital area and looks forward to the results of Perspectum's biomarker study," comments Donna Cryer, President, and CEO of the Global Liver Institute.
This project is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award U01FD006880 totaling $249,940 with 100 percent funded by FDA/HHS. The contents of this press release are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. Government.
About the Massachusetts General Hospital
Massachusetts General Hospital, founded in 1811, is the original and largest teaching hospital of Harvard Medical School. The MGH Research Institute conducts the largest hospital-based research program in the nation, with an annual research budget of more than $1 billion and comprises more than 8,500 researchers working across more than 30 institutes, centers, and departments. In August 2018, the MGH was once again named to the Honor Roll in the U.S. News & World Report list of "America’s Best Hospitals."
Perspectum delivers cutting-edge digital technologies that help clinicians provide better care for patients with liver disease, diabetes and cancer. With a strong focus on precision medicine using advanced imaging and genetics, our vision is to empower patients and clinicians through quantitative assessments of health enabling early detection, diagnosis, and targeted treatment. With a diverse team of physicians, biomedical scientists, engineers and technologists, Perspectum offers a way to manage complex health problems at scale. For more information, visit perspectum.com.