JAX California facility obtains clinical laboratory licensure, CLIA registration

Sacramento, Calif. -- The Jackson Laboratory is now a California-licensed and CLIA-registered clinical laboratory qualified to accept and process clinical samples of human cells and tissues, including tumors for new, highly targeted preclinical cancer studies.

Licensing by the California State Department of Health and registration under CLIA (Clinical Laboratory Improvement Amendments), which is granted through the Center for Medicare and Medicaid Services of the U.S. Department of Health and Human Services, demonstrates that the JAX facility meets rigorous standards to ensure quality laboratory testing.

"Obtaining these approvals to accept patient samples is a vital step into clinical research for us, as we work to build a new kind of precision medicine," says Jackson Laboratory President and CEO Edison T. Liu, M.D.

The state and federal approvals cover the Laboratory’s processes, procedures and facilities to accept human tumors and evaluate tumor response to anti-cancer drugs. This evaluation can help the treating physicians identify drugs that may be effective at either shrinking or inhibiting the growth of the patient’s tumor.

In addition to this clinical work, The Jackson Laboratory is developing new preclinical strategies and resources to address the enormous cost and high failure rate of cancer drug development. Using a special JAX mouse that can accept human tissues, the Laboratory is developing more than 200 diverse patient-derived tumor xenograft (PDX) mouse models. The PDX models provide a platform for the study of specific cancer types as well as testing new treatment approaches.

To date the Laboratory has partnered with nearly two dozen hospitals and cancer centers across the nation to collect patient tumor samples, and developed hundreds of PDX models for 16 cancer types, including lung, brain, bladder, breast, prostate, hematologic and colorectal cancers.

The Jackson Laboratory is an independent, nonprofit biomedical research institution based in Bar Harbor, Maine, with facilities in Sacramento, Calif., and Farmington, Conn. It employs a total staff of more than 1,500. Its mission is to discover precise genomic solutions for disease and empower the global biomedical community in the shared quest to improve human health.