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Bio-Techne Companion Diagnostics
We are your trusted end-to-end precision medicine partner. Offering service solutions spanning biomarker discovery through worldwide, multi-channel commercialization of CDx products. We work with partners from early-stage discovery to clinical trials and regulatory approval in major diagnostic and medical markets around the world to ensure a smooth and successful co-development product with our partners’ drug programs.
Discover.
- Biomarker discovery and assay development leveraging platform-independent, multi-omic solutions (genomic to proteomic) and spanning liquid biopsy to tissue extraction
- Industry-leading bioinformatics and software capabilities to discover signatures with clinical utility
Create.
- Flexible assay design using a wide variety of platforms
- History of clinical trial testing and support
- cGMP production capabilities
- Easily kit products for commercial use
Accelerate.
- Global capabilities and channel partnership opportunities
- Regulatory proficiency including 510(k), US and international registration, CLIA certified labs
- Reimbursement expertise including CPT codes and beyond
Biomarker Discovery
We offer unique capabilities in liquid biopsy, exosomes, and challenging targets, paired with deep domain expertise in regulatory and reimbursement, allowing us to offer customizable solutions.
Create Flexible Clinical Assays
Our Molecular Diagnostics team has extensive expertise in the development of products for various gene targets and a proven track record in the development of kitted products for US and international distribution.
Accelerate Your Companion Diagnostic Journey
Expanding CDx Opportunities Beyond Cancer:
Stratifying Huntington's Disease Patients
Companion diagnostics will be essential for bringing desperately needed new treatments to market for disease areas well beyond cancer. At Bio-Techne, we recently teamed up with a biopharma company to develop a clinical trial assay for Huntington’s disease, an incurable neurodegenerative condition. Our development efforts allowed pharma researchers to generate the biomarker information they needed from a single, streamlined diagnostic tool, replacing three tedious labor-intensive tests that were previously performed on three different technology platforms for each prospective patient.
Improving Diagnostic Methods:
Early Disease Detection in Alzheimer's
In another collaboration, Bio-Techne experts worked with researchers running a clinical study of Alzheimer’s disease where key genotype data was needed to evaluate patients and predict their near-term risk of developing cognitive symptoms. We provided a validated PCR/CE kit and prototype reagents to measure two key biomarkers: TOMM40 and APOE to help assess the performance of a clinical trial assay, with results indicating excellent concordance.
Review the Early Disease Detection in Alzheimer’s Scientific Poster >>
