Broad Institute launches CLIA-certified Clinical Research Sequencing Platform

Approval received from state to process clinical samples

October 21st, 2013 —

Leaders of the Broad Institute announced today the completion of a critical step on the path toward establishing a Clinical Research Sequencing Platform (CRSP) at the Broad. The institute has passed its Massachusetts state inspection, and now has approval from the state to begin processing clinical samples under CLIA – a certification allowing diagnostic laboratories to perform clinical testing, including sequencing, on patient samples.

“Through CRSP, the Broad will leverage our substantial expertise in genome sequencing, process engineering and data processing to help tackle technical and analytic challenges in the use of genome sequence in the clinic,” said Stacey Gabriel, director of the Broad’s Genomics Platform. “Certification from the state of Massachusetts represents a major accomplishment for the entire staff of the Genomics Platform, and we are now ready and eager to receive samples and partner with clinical researchers in academic medical, biotechnology, and pharmaceutical organizations.”

The immediate goal of CRSP will be to provide access to world-class, CLIA-certified deep sequencing to support innovation and research by academic medical centers and other partners into the effectiveness of clinical diagnostics to inform decisions regarding patient care, including the care of patients with rare diseases. CRSP will also provide technical expertise and CLIA/CAP/QSR-compliant deep sequencing to support clinical research including clinical trials by researchers in academia and industry that require genome sequence information in the course of their projects, for example, in the case of designing genome-guided cancer therapy. In addition, CRSP will work with partners to develop and undertake flagship research projects as needed to drive the clinical utility of genome sequence in the prediction, stratification and diagnosis of disease, contributing to the efforts of the larger medical and scientific community to build the foundation needed to establish the utility of genomic information in medicine.

“Developing and applying genomic methods that advance medicine is central to the mission of the Broad Institute. Right now, there is a pressing need for technology development and clinical research that enable learning about genome sequencing in the clinic,” said David Altshuler, deputy director and chief academic officer of the Broad Institute. Altshuler is also the director of the Broad’s Program in Medical and Population Genetics, and professor of medicine and genetics at Massachusetts General Hospital and Harvard Medical School. “Working with partners, CRSP will contribute to the efforts by the greater medical and scientific community to build the knowledgebase needed to evaluate and establish the clinical utility of genomic information.”

About the Broad Institute of Harvard and MIT

The Eli and Edythe L. Broad Institute of Harvard and MIT was launched in 2004 to empower this generation of creative scientists to transform medicine. The Broad Institute seeks to describe all the molecular components of life and their connections; discover the molecular basis of major human diseases; develop effective new approaches to diagnostics and therapeutics; and disseminate discoveries, tools, methods and data openly to the entire scientific community.

Founded by MIT, Harvard and its affiliated hospitals, and the visionary Los Angeles philanthropists Eli and Edythe L. Broad, the Broad Institute includes faculty, professional staff and students from throughout the MIT and Harvard biomedical research communities and beyond, with collaborations spanning over a hundred private and public institutions in more than 40 countries worldwide. For further information about the Broad Institute, go to