TruQ Controls - Technology

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.

Regulatory Agency Evaluation

TruQ Her2/neu products have been evaluated independently by the College of American Pathologists and Canadian IQC. 1,600+ laboratories participated in testing.

Results showed that TruQ Controls significantly outperformed most tissue or cell line controls by:

Higher degree of concordance

Lower reported absence of tumor

Lower equivocal results

Lower reported tissue loss in staining

Research

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.

*1. 3D Tissue Microarray Controls: A Potential Standardization Solution, Applied Immunohistochemistry & Molecular Morphology: October 2018 - Volume 26 - Issue 9 - p 676-681 doi: 10.1097/PAI.0000000000000495

*2. Getting controls under control: the time is now for immunohistochemistry. J Clin Pathol. 2015 Nov;68(11):879-82. doi: 10.1136/jclinpath-2014-202705. Epub 2015 Aug 18. PMID: 26286753; PMCID: PMC4680144.

Major Users

TruQ bioengineered controls are currently in use to validate IHC test results at several major cancer centers and independent laboratories nationwide.

Development

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).