Bioengineered tissue microarray controls are created using a patented histosynthesis process utilizing cell lines and stromal cells derived from human tissue.
This results in a product that looks like tissue and delivers known levels of biomarker expression required for monitoring assay performance and improving accuracy of diagnosis.
TruQ shares essential parameters with tissue controls including morphology, cellular polarity, stromal components and known biomarker expression profile.
The innovative process provides the only consistent bioengineered tissue control of its kind available, elevating quality control processes for laboratory IHC testing globally and eliminating availability and ethical constraints.
A peer-reviewed study in Applied Immunohistochemistry and Molecular Morphology demonstrated that TruQ tissue microarray controls outperformed standard tissue controls in consistent expression. Coefficients of variation for Her2/neu expression on TruQ slides measured 3.18% over time, below the widely accepted 5% threshold for test reproducibility1.
In addition, a study published in the Journal of Clinical Pathology2 indicates that one of the reasons laboratories fail in proficiency testing challenges is the use of controls which only display a high expression of the antigen of interest, leading to inadequate optimization of assays. TruQ controls provide a simple mechanism for pathologists to review 2+/3+, 3+, and negative controls together with each patient sample to more accurately classify each result, confident that both controls and patient tissue underwent the exact same testing environment.
TruQ bioengineered controls are currently in use to validate IHC test results at several major cancer centers and independent laboratories nationwide.
TruQ technology development is led by Dr. Ashraf Imam.
Dr. S. Ashraf Imam, M.S., Ph.D., is the Director of Molecular Pathology at StatLab and lead R&D pathologist steering development of the technology powering TruQ Bioengineered Controls.
He graduated with a Master’s Degree with honors from Queen’s University in Belfast, UK, and went on to earn a Ph.D. from University of London, completing his fellowship in Pathology and Cancer Biology in the departments of Pathology and Cancer Center at the University of Southern California.
His career has focused heavily on breast cancer research with academic appointments in both the UK at Queen’s University and in the US at University of Southern California.
Dr. Imam is a respected member of the diagnostic pathology research community, with over 80 publications in peer-reviewed journals. He is active on the editorial board of industry journals, a frequent speaker at workshops and industry meetings, and holds numerous patents in diagnostic pathology.
Significant accomplishments in his research include development of a 3D coculture model system for the study of stromal cells in breast cancer progression and development of chemoresistance—used in TruQ controls—and development of a new strategy for identification of high-risk triple negative invasive breast cancer or ductal carcinoma in situ (DCIS) signature genes. He also developed and patented several antibodies for use in cancer detection including RCC (renal cell carcinoma), BLA.36 (B Cell), and LEA-135 (Breast Epithelial Cells).
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