DF/HCC's Specialized Histopathology Core Receives CLIA Certification

OCTOBER 17, 2017

DF/HCC’s Specialized Histopathology Core (SHP) recently received news that it had received CLIA certification – a certification that allows the Core to perform tissue-based biomarker tests needed for enrollment of patients in clinical research trials. This capacity will fill a critical testing gap that lies between discovery of markers through basic research and standard of care diagnostic testing for cancer patients. It caps off roughly 3 years of work, beginning with entry into a College of American Pathologists (CAP) proficiency program in 2014 and culminating in receipt of CLIA certification on August 29, 2017. “Teri was tireless in working to make this happen” Jon Aster, MD, PhD (BWH), SHP Core Director and Co-Leader of DF/HCC’s Lymphoma and Myeloma program said during an interview, describing his Core’s manager, Teri Bowman, and her role in achieving CLIA certification.

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

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

Created in 1999, the Specialized Histopathology Core was one of the first pathology cores to exist in any cancer center. “In the beginning, everything we did was in support of basic science studies” Dr. Aster said, and went on to describe that over time, the need for biomarker studies at the interface between treatment and diagnostics has increased dramatically as cancer therapy has moved away from conventional chemotherapy to targeted therapies, which often require biomarker studies for patient selection. “Now that we are CLIA licensed, we’ll have a much greater ability to support this type of need,” he continued.

Increasingly, the core has become involved with biomarker tests that are important not only for doing correlative science on patients who are part of clinical trials, but also for gauging eligibility for trial entry. “The motivation to get first CAP certified, then a CLIA license, was to enable us to better serve that need”, said Dr. Aster. Examples include identification of a particular mutated protein or overexpression of a gene product like HER2/neu, c-MET, or other surface markers that are the targets of small molecule or biologic inhibitors.

Three of the Cores IHC stainers - Elvis, Sonny & Cher

Three of the Cores IHC stainers - Elvis, Sonny & Cher

The Core also has recently purchased additional automated immunohistochemical stainers, hired additional staff to increase capacity and decrease turnaround time, and is in the process of implementing a barcoding sample tracking system, all in an effort to better serve DF/HCC investigators. The need for the work the Core performs can be seen in its increasing work volume. It currently provides services to several hundred DF/HCC PIs and every basic science- and disease-focused program in DF/HCC, generates over 100,000 slides each year, and serves a number of external academic institutions and industry.

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