By Allison Proffitt
October 20, 2013 | The Broad Institute today announced that it has passed Massachusetts state inspection, and can begin processing clinical samples as a CLIA-certified lab.
“We’re trying to leverage and make best use of the infrastructure and expertise that we’ve established over time in sequencing and data processing and data management and trying to apply this in the clinical setting,” Stacey Gabriel, director of the Broad’s Genomics Platform, told Bio-IT World.”
The announcement is a critical step in establishing a Clinical Research Sequencing Platform (CRSP) at the Broad.
The CLIA lab will make use of the Broad’s 50 HiSeq 2500 instruments and will offer exome sequencing, returning a “technical exome report,” Gabriel said. She expects the lab to process 100-200 samples per week to start, though she says the Broad is well-equipped to scale that number up if there is sufficient interest.
Gabriel said she expects the Broad’s customers to be, “people who are performing clinical research studies—academic medical centers, other institutions including biotech or pharma groups who need to have this level of CLIA certification for their sequencing studies.” She mentioned specifically NIH research grants now calling for CLIA-certified sequencing.
The Broad will not be offering interpretation, just, “the very best set of exomes and variant calls,” Gabriel said. Partners will deliver or interpret results and inform decisions regarding patient care, including the care of patients with rare diseases. Gabriel said that the Broad is not interested in a direct-to-consumer offering.
Gabriel does expect the CRSP offerings to expand soon though. “We’re developing a cancer panel, which will have 400 genes and other regions of interest for cancer genomics. We’d offer that for tumor-normal sequencing. That will probably be available early next year,” she said. “We’ve also got to decide about activities like whole genome sequencing, or transcriptome sequencing.”
“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. “Right now, there is a pressing need for technology development and clinical research that enable learning about genome sequencing in the clinic. 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.”
Gabriel says that the program is a logical progression from the Broad’s research work.
“I think people don’t really think of us in a clinical setting or a CLIA setting. We’re more of a big research operation,” she said. “We are really trying to couple these things together and apply what we’re learning in research directly to the clinical data generation. We hope that people are interested to work with us.”