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Clinical Trials

Clinical Trials

Clinical cancer trials are a key element of cancer research at HCI, and they increasingly require newly discovered molecular diagnostics testing not yet available as Clinical Laboratory Improvement Amendments (CLIA) certified tests. CLIA certification is a complex process requiring an average of a year or more per assay, which is too long for clinical trials attempting rapid deployment of new discoveries for cancer patients. The Biorepository and Molecular Pathology Shared Resource was developed to enable pre-CLIA certified patient molecular testing to support clinical research at HCI.

Once a patient is consented on a clinical trial, the Biorepository and Research Histology sections of the BMP Core facilitate rapid specimen procurement of either fresh/frozen or FFPE tissue. A staff pathologist verifies the diagnosis and identifies the specimen or tumor area for molecular testing. Information about the patient and specimen are entered into itBioPath, a biospecimen tracking database, and a request for testing is submitted through GNomEx, a LIMS and data repository system. After receiving the specimen, the Molecular Diagnostics Laboratory isolates DNA and performs the genetic testing. A staff scientist analyzes the data and generates an easy to read report for the clinical research coordinator to provide to the requesting clinician. Both the molecular testing report and results are uploaded to GNomEx, which enables future queries of the genetic data that is linked to the patient via itBioPath.

The Molecular Diagnostics laboratory is currently performing genetic testing of consented patient specimens for several investigator initiated clinical trials at HCI utilizing the Sequenom MassArray and Illumina MiSeq.

Sequenom Clinical Research

The Sequenom MassArray is a mass spectrometry based high throughput SNP genotyping and somatic mutation detection platform. This technology is an excellent choice for clinical research because of the ability to go from DNA to data in a single day at very low cost.

Illumina MiSeq Clinical Research

The Illumina MiSeq is a benchtop sequencer capable of generating upwards of 15 Gb of output in approximately 24 hours making it ideally suited for rapid turnaround of clinical research specimens.

Any data generated by the Molecular Diagnostics Laboratory are for research purposes only. The results are NOT CLIA certified and cannot be used for standard of care treatment decisions.