About the Laboratory

The Molecular Diagnostics Laboratory integrates advanced genomic technologies, analytical rigor, and collaborative expertise to expand access to molecular characterization of cancer and support precision-oncology research. The laboratory operates as a CLIA-certified, CAP-accredited academic facility within the Fralin Biomedical Research Institute at Virginia Tech.

REGIONAL CONTEXT

The cancer landscape in Southwest Virginia reflects both national trends and regional factors. Cancer incidence and mortality rates are above state and national averages, particularly for lung, colorectal, breast, and endometrial cancers. Contributing factors include tobacco use, obesity, and socioeconomic conditions such as limited access to preventive care. Locating advanced molecular diagnostics within the region shortens the geographic distance between specimen and analysis and situates molecular characterization within the same clinical and research community it serves. 

HISTORY

 Molecular Diagnostics Laboratory launched at the Fralin Biomedical Research Institute on April 20, 2020, in response to the COVID-19 pandemic. The Food and Drug Administration granted Virginia Tech permission to deploy its novel assay to analyze SARS-CoV-2 samples under an Emergency Use Authorization application filed in April 2020.

Health districts across Southwest Virginia sent coded and deidentified samples to the Virginia Tech laboratory for analysis. Specimens were processed by researchers at the Fralin Biomedical Research Institute in Roanoke using a quantitative real-time polymerase chain reaction (qRT-PCR) protocol to detect viral genetic material. The laboratory developed a process that frequently returned results within 24 to 48 hours.

By July 2025, the laboratory had reported more than 230,000 SARS-CoV-2 test results since its launch. In parallel, the laboratory redirected its infrastructure and expertise toward advanced cancer genomics, an application area that draws on the same regulatory framework and quality systems developed during the SARS-CoV-2 response and that requires assay-specific analytical validation.

Institutional Home

The laboratory operates within the Fralin Biomedical Research Institute at Virginia Tech, in Roanoke, Virginia. The Institute's translational research environment supports the integration of clinical molecular diagnostics with active biomedical research, and the laboratory's activities are coordinated with regional healthcare partners.

Facilities

The laboratory occupies 5,250 ft² of dedicated laboratory space at 4 Riverside Circle in Roanoke, subdivided into functional zones designed for biosafety and workflow linearity. Office and computational infrastructure totals an additional 4,050 ft². A full description is available on the Technology and Laboratory Infrastructure page.