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Broad Gets Massachusetts Approval to Sequence Clinical Samples under CLIA

NEW YORK (GenomeWeb News) – The Broad Institute has obtained approval from the state of Massachusetts to start processing clinical samples under CLIA, the institute said today.

After passing inspection by the state, the Broad has completed "a critical step on the path toward establishing a Clinical Research Sequencing Platform," according to a statement from the institute, and can now perform clinical testing, including sequencing, on patient samples.

Through CRSP the Broad plans to apply its expertise in 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 institute's Genomics Platform, in a statement.

CRSP plans to provide CLIA-certified sequencing to academic medical centers and other partners for research into the effectiveness of clinical diagnostics to inform patient care, for example in patients with rare diseases.

In addition, CRSP plans to provide sequencing compliant with CLIA, CAP, and the FDA's Quality Systems Regulations, as well as technical expertise, to support clinical research, such as clinical trials by groups in academia and industry that require genomic sequence information.

CRSP will also partner with others on research to drive the clinical utility of genome sequences for the prediction, stratification, and diagnosis of disease.

"Developing and applying genomic methods that advance medicine is central to the mission of the Broad Institute," said David Altshuler, deputy director and chief academic officer of the Broad Institute, in a statement. "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."