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News / 03.26.20

Broad Institute’s CLIA-certified testing center begins processing COVID-19 patient samples; is named a Massachusetts state reference lab

Michelle Cipicchio, process development manager, prepares a plate of samples to be run through the automated viral RNA extraction process. Water is used here during a training run on March 22, 2020. Credit: Scott Sassone
By Broad Communications

Facility now has capacity to process approximately 2,000 COVID-19 tests per day; Results returned in 24 hours on first day of processing, falling to an average 12-hour turnaround time from receipt.

Medical providers: For precise instructions on how to prepare and send samples directly to the Broad Institute Clinical Research Sequencing Platform for processing, click here.
 

Update June 5, 2020: The Broad's Clinical Research Sequencing Platform can now process approximately 35,000 COVID-19 tests per day.

Working in partnership with the Commonwealth of Massachusetts, Massachusetts State Public Health Laboratory, and area hospitals, the CLIA-certified lab of the Broad Institute of MIT and Harvard has begun processing COVID-19 test samples from patients across New England. The lab returned its first batch of results back to physicians within 24 hours of receiving samples. As teams at the testing center apply additional automation, tests will take approximately 12 hours to complete from receipt.

By adapting an existing facility used to process clinical samples for genomic assays, Broad Institute has quickly scaled the testing center to create capacity to process approximately 2,000 COVID-19 tests per day. This is part of a larger effort, including through the Baker-Polito Administration’s COVID-19 Response Command Center, to create partnerships spanning government, academia, and the private sector to quickly grow the ability to test and support patients during the ongoing COVID-19 pandemic.

The Clinical Research Sequencing Platform, LLC (CRSP) is a subsidiary of the Broad Institute. CLIA-certified and CAP (College of American Pathologists) accredited, it can return data to physicians for use in diagnostics, patient care, and clinical trials. It is highly automated so that it can handle large numbers of samples. This lab is authorized to process samples collected in hospitals and other clinical settings and then deliver the results securely back to physicians. The lab has completed the FDA-developed validation protocol for the assay.

On Tuesday, March 24, CRSP began to receive and process test kits from area hospitals and clinics. The number of kits is expected to increase as testing expands across the region.

“Over the last two weeks, many people at the Broad came together in an extraordinary effort to do what would normally take months: adapt and validate a clinical diagnostic test, create new processes, and even build new rooms in our labs to be able to help increase COVID-19 testing,” said Stacey Gabriel, institute scientist and senior director of the Broad’s Genomics Platform.

Broad has worked closely with the Massachusetts Department of Public Health, the departments of pathology at Massachusetts General Hospital, Brigham and Women's Hospital, and other area hospitals and hospital networks to put the CRSP’s high-throughput genomic capabilities at the disposal of the Commonwealth to enable increased capacity for COVID-19 diagnostic testing.

Broad adapted the existing facility to process COVID-19 patient samples and accurately perform the existing CDC RT-qPCR COVID-19 diagnostic test at large scale. This involved reconfiguring the existing facility, boosting training for technicians and purchasing new protective gear for them, as well as establishing additional containment, safety, and cleaning procedures to keep team members safe.

The COVID-19 diagnostic testing facility is connected to the Broad’s Genomics Platform. In 2013, the platform launched an effort to provide high-quality, validated clinical sequencing for use in medical care and clinical research, and to do this at high scale using advanced robotics.

“Scientists across the Broad Institute and around the world are collaborating quickly and closely to help understand and overcome COVID-19,” said Eric Lander, president and founding director of the Broad Institute. “We are proud to also be able to contribute directly to patient care by helping to speed access to diagnostics. It’s been wonderful to work with many partners, all coming together at breakneck speed, to deliver support that’s urgently needed.”

“The focus here has always been on applying fluid-handling automation and other robotics to allow us to work at higher scale and higher throughput,” said Niall Lennon, institute scientist and senior director of translational genomics and product development in the Broad’s Genomics Platform. “We have repurposed all of that knowledge and those pieces of equipment to process samples for COVID-19 testing in the same manner.”

Even as the diagnostic facility has scaled up, the Broad Institute has shifted to a primarily remote workforce, with only about 10 percent of the Broad community working on-site. In total, approximately 40 people are working specifically on the diagnostics effort, in teams that allow the facility to operate 24 hours a day. The team has been fielding offers to volunteer to help with the effort, but is already fully staffed.

Broad Institute does not collect samples directly from patients. Members of the public seeking testing should call their health care provider.

Clinical Research Sequencing Platform, LLC (CRSP) is a subsidiary of the Broad Institute and is a certified CLIA lab.