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ADVANCING PRECISION ONCOLOGY

VIRGINIA TECH
MOLECULAR DIAGNOSTICS LAB

About the Molecular Diagnostics Lab

By integrating research innovation with certified diagnostic excellence, the Virginia Tech Molecular Diagnostics Lab serves as a regional and national resource, bridging the gap between discovery and patient care to advance precision medicine and public health.

The Molecular Diagnostics Laboratory at the Fralin Biomedical Research Institute (FBRI) is equipped with cutting-edge technologies that support a full spectrum of molecular analyses, from pathogen surveillance to cancer genomics.

The laboratory houses multiple Ion Torrent Genexus integrated sequencers for rapid, automated next-generation sequencing, complemented by high-throughput CFX384 real-time PCR systems for precise amplification and quantification of nucleic acids.

Robotics-based automation enables scalable and reproducible workflows for sample processing, assay preparation, and high-volume molecular testing. Digital PCR technology provides ultra-sensitive detection and absolute quantification of genetic targets, while multiplexed ELISA platforms enable comprehensive protein and antibody profiling.

Together, these systems allow simultaneous investigation of infectious agents, host responses, and genomic alterations, ensuring the laboratory’s readiness to address challenges in clinical research, public health, and precision oncology.

Personalized cancer care will bring genomic testing closer to home. Our goal is to improve access to genomic testing by providing fast, local, patient-focused diagnostics.

Our automated end-to-end workflow is less error-prone and reduces labor costs, with only 20 minutes of hands-on time.

Faster turnaround times and flexible batching simplify workflows and provide rapid turnaround on comprehensive panels, making it easier for cancer patients to be prescribed the right drug the first time.

Smaller sample input requirements allow for multiple sample types — single nucleotide variants, insertions or deletions, tandem repeats, duplications, fusions — and fewer questionable or unsatisfactory results.

Integrated, customizable reporting delivers reports oncologists prefer within 24 hours, which means patients learn their diagnosis — and can begin treatment — sooner.

ACCREDITATION

Clinical Laboratory Improvement Amendments and College of American Pathologists accreditation enable our Molecular Diagnostics Laboratory to move discoveries from the research bench to the patient bedside with speed and confidence. These certifications ensure that all laboratory-developed tests meet the highest standards of quality, accuracy, and clinical relevance.

Within this certified framework, novel biomarkers, genetic signatures, and therapeutic targets can be rapidly validated and implemented for patient testing. This reduces regulatory delays, strengthens collaboration with clinicians and industry partners, and ensures that innovation translates directly into better diagnostics and improved care. CLIA and CAP accreditation position our laboratory as a trusted bridge between scientific discovery and precision medicine.

CAP (College of American Pathologists) accreditation represents the highest standard of excellence for clinical laboratory quality and performance. For a molecular diagnostics laboratory, CAP accreditation goes beyond regulatory compliance by ensuring adherence to rigorous peer-reviewed standards that encompass every aspect of laboratory operations, from test validation, personnel competency, and biosafety to data integrity, quality management, and continuous improvement. This accreditation provides formal recognition of the lab’s technical proficiency and commitment to patient safety, instilling confidence in clinicians, regulatory bodies, and collaborators. Moreover, CAP-accredited laboratories are part of a global network dedicated to maintaining cutting-edge practices and innovation in diagnostic medicine, positioning them as trusted partners in clinical care, translational research, and precision oncology.

CLIA (Clinical Laboratory Improvement Amendments) certification ensures that a molecular diagnostics laboratory meets the highest federal standards for quality, accuracy, and reliability in clinical testing. This certification demonstrates that the lab operates under rigorous regulatory oversight, with validated procedures, trained personnel, documented quality control, and regular proficiency testing. For clinicians and patients, CLIA certification provides confidence that test results are clinically valid and reproducible, supporting accurate diagnosis and treatment decisions. For the laboratory, it enables the performance and reporting of human diagnostic tests, fosters trust among clinical and research partners, and positions the facility for participation in translational and precision medicine initiatives requiring certified testing environments.

Our history