Left to right: Core personnel Teri Bowman, Elizabeth Morgan, Jon Aster, and Sabina Signoretti

The Specialized Histopathology Core-Longwood, housed at BWH, applied for, and was recently granted, CLIA certification to further support departments at the Brigham, the Dana-Farber/Harvard Cancer Center and Partners HealthCare. CLIA, or Clinical Laboratory Improvement Amendments, is often cited as a necessary qualification for any lab characterizing samples from patients who may qualify for clinical trial enrollment. This certification will allow the lab to provide support to a wider range of trials—ideally lightening the load for other clinical labs in the hospital.

“Now clinical researchers have a venue that they can use to support their work,” said lab manager Teresa Bowman.

This core combines the skills and resources of a research lab with those of a clinical lab. The additional certification allows the core to perform tissue-based biomarker tests needed for clinical trial enrollment, further establishing the core’s position in helping to translate research findings into clinical practice.

After three years of careful preparation, beginning with entry into a College of American Pathologists (CAP) proficiency program in 2014, the core received certification in August of 2017. Though the core is identified as a research laboratory, it also accepts patient samples. Technicians can help test samples to determine a patient’s eligibility for a clinical trial or analyze biopsies used for research purposes.

“As the interface between the lab and clinical trials we play a variety of roles. The lab is positioned to help in a variety of capacities, including clinical trial design as well as the conduct of trials,” said Jon Aster, MD, PhD, SHP Core Director and Co-Leader of DF/HCC’s Lymphoma and Myeloma program.

The core has grown tremendously over the years, from a handful of pathology technicians processing mainly zebrafish samples to five staff pathologists and eight technicians who directly contribute to clinical research and potential treatments with their analyses.

“We work hand in hand with clinical teams,” said Bowman. “Now that we have certification, we hope to see more clinicians reaching out for help with tissue-based biomarker tests within the context of clinical trials.”

The core currently provides services to several hundred DF/HCC principal investigators and numerous departments and programs, and generates over 100,000 slides each year. Additional resources and staff are increasing capacity and decreasing turnaround time. The core will also be implementing a barcode system for their samples in the next year to meet the organizational demands that come with its increasingly complex role in supporting basic and clinical research.

“The exciting and unique aspect of CLIA is that we can now support a wide variety of biomarker-directed work, such as those that may help to determine optimal immune checkpoint therapies for cancer patients,” said Aster. “We can serve as a support vehicle for clinical research not only in Boston, but also for other academic centers in the US and even internationally.”

To learn more and to contact the core, click here: http://www.dfhcc.harvard.edu/research/core-facilities/specialized-histopathology/