Molecular Diagnostics Laboratory

The Molecular Diagnostics Laboratory (MDL) is a Temple University Health System facility in the Pathology Department of Fox Chase Cancer Center, and provides system-wide oncology and non-oncology tests for DNA, RNA, and protein analytes. The MDL is CLIA-licensed in Pennsylvania and accredited by the College of American Pathologists for high-complexity testing of patient samples used in clinical care.
The MDL staff includes ten medical technologists, two data coordinators and a bioinformaticist, a lab manager, three technical or assistant directors, and a director. The laboratory is supported by a medical director and six pathologists who review and integrate molecular test reports. The test menu includes multi-gene panels for DNA or RNA sequencing, single-gene sequencing tests, genome-wide DNA copy number assays, and standardized and custom single nucleotide genotyping panels. Testing is available for fresh or formalin-fixed tissues, enriched cell fractions, whole blood, plasma cell-free DNA, and fingernail DNA. Over 4000 tests per year are performed.
The laboratory occupies 3140 sq. ft. of space in the Young Pavilion. Major equipment includes Illumina NextSeq 2000, NextSeq 500, MiniSeq and MiSeq sequencers, cartridge-based diagnostic systems including a Roche Cobas 6800, Biocartis Idylla and Cepheid GeneXpert, a six-station two-scanner Affymetrix microarray system, multiple ABI 3500 capillary electrophoresis instruments, a Qiagen QIAcuity digital PCR instrument, two QuantStudio 12K Flex and a Roche LightCycler real-time PCR instruments, multiple QiaCube robotic extractors, chemagic360 and KingFisher high-throughput extractors, and a Purigen isotachophoresis instrument. Data analysis is performed on two in-house multi-core servers with remote supplemental storage on a 25TB Isilon partition.
Pre-clinical molecular test development is conducted by a dedicated senior scientist in an MDL-associated laboratory occupying 980 sq. ft. in the Reimann Building.
Patient reports are assembled in the CoPath electronic pathology system and transferred upon pathologist’s signout to the Epic medical record and to Epic Revenue Cycle for reimbursement billing. Alternatively, clinical trials and research requiring clinical-grade testing are supported by the MDL with CLIA- and HIPPA-compliant workflows to receive and track samples and to transfer assay data to study databases.