Rutgers’ Human Genetics Institute Lab Expands Into Clinical Testing

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Newswise RUCDR Infinite Biologics, a unit of Rutgers Human Genetics Institute of New Jersey, has taken a major step toward expanding its focus from conducting and supporting genomic research, where its become a recognized global leader, to the rapidly growing field of clinical genomics.

RUCDR, which is the worlds largest university-based biorepository, recently earned its initial certification from the federal Clinical Laboratory Improvement Amendments program. CLIA, as its commonly known in health care, is run by the Centers for Medicare and Medicaid Services (CMS) of the U.S. Department of Health and Human Services. CMS mandates that all tests for the diagnosis, treatment and prognosis of disease in human subjects be carried out in a CLIA-certified laboratory. Certification is granted only after an operation undergoes a rigorous review, including on-site inspection. The State of New Jersey also recently awarded the new lab at Rutgers a Clinical Laboratory Improvement Services license.

Building on 15 years of innovative and globally influential genomics research operations and services, RUCDR aims to provide clinical-grade diagnostics for a wide variety of diseases. In the first instance, RUCDR plans to support the precision medicine program and advanced treatment protocols being developed at the Rutgers Cancer Institute of New Jersey, which is located in New Brunswick. RUCDR is nearby on Rutgers campus in Piscataway.

Working with the Cancer Institutes physicians and researchers, RUCDR will use state-of-the-art genetic and genomic technologies to develop tests for the diagnosis and management of several types of cancer. Clinical testing will be carried out under the direction of staff who are board-certified in clinical molecular genetics, clinical cytogenetics and medical genetics. The laboratory data will be reviewed by and correlated with the clinical data by Cancer Institute of New Jersey oncologists.

Jay A. Tischfield, chief executive officer and scientific director of RUCDR and Duncan and Nancy MacMillan distinguished professor of genetics at Rutgers, said: The receipt of CLIA certification is a major milestone in the evolution of RUCDR Infinite Biologics from a cell and DNA repository to an organization that is actively involved in the development and implementation of diagnostic tests based on next-generation sequencing technologies. This certification is a critical step toward providing comprehensive cancer diagnostic services to the Cancer Institute and its network of hospitals. We further anticipate expanding our services to other institutions in the near future.

RUCDR forged the strategic and innovative Bioprocessing Solutions Alliance with BioStorage Technologies Inc. nearly two years ago to provide industry with an integrated, state-of-the-art scientific approach and technology infrastructure for the delivery of advanced sample bioprocessing and biobanking solutions. CLIA certification supports RUCDRs mission to engage with major pharmaceutical companies and research labs that will enable gene discovery leading to diagnoses, treatments and, eventually, cures for diseases.

RUCDR Infinite Biologics has instrumentation and expertise in place for analyzing genetic alterations in specific genes, or at the exome or whole genome level, said Andrew I. Brooks, chief operating officer and director of technology development for RUCDR and associate professor of genetics. Our technologically advanced infrastructure will enable us to identify genetic alterations that are specific for a given tumor so that appropriate therapies can be directed at that particular tumor.

RUCDR was one of the first biorepositories to be accredited by the College of American Pathologists in 2012. The Cancer Institute of New Jersey is the states only National Cancer Institute-designated Comprehensive Cancer Center.

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Rutgers' Human Genetics Institute Lab Expands Into Clinical Testing