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Bio-Techne Companion Diagnostics

Bio-Techne offers precision medicine services to pharma partners spanning the continuum from biomarker discovery to post-market commercialization of companion diagnostic products. Our platform-agnostic approach to biomarker discovery and clinical trial assay development, paired with clinical trial sample testing readiness at our CLIA labs and international regulatory expertise allows us to offer customizable solutions so that a pharma partner can improve their drug’s likelihood of success and deliver novel treatments to the patients most likely to benefit, faster.

Bio-Techne  - Together Transforming Companion Diagnostics
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  • Bioinformatics expertise to discover signatures with clinical utility

  • Specialized expertise as a leader in Exosome-based R&D

  • Proprietary chemistries for difficult repetitive and other structural variants

  • Innovative technologies for spatial biology and automated protein-based discovery and detection

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  • Development of biomarker signatures and validation for clinical use
  • Diagnostic systems comprising reagents and assay analysis software built for the most stringent regulatory requirements
  • Development and commercialization of robust products with high quality, reduced complexity, and optimized workflow
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  • Multiple CLIA labs sites to support global testing needs
  • Experienced regulatory team to support a broad range of submissions, including 510(k) and PMA
  • Products registered in countries around the world
  • Commercial reach in over 50 countries, over 200 labs are active users
  • cGMP manufacturing in our FDA registered ISO 13485 facility

Dynamic Expertise in Companion Diagnostics

Spanning Platforms, Sample Types, Analytes, and Diseases

CDx DNA, RNA, Protein Equation

Ability to Unlock Challenging Regions of DNA

Asuragen, a Bio-Techne brand, has an extensive history in the development of highly sensitive assays for regions of DNA that are challenging to sequence.  

Our proprietary chemistries can detect and analyze these targets with unprecedented ease. Capabilities extend to:

  • Complex single nucleotide variants
  • Pseudogene discrimination
  • Gene conversions
  • Methylation
CDx Complex Molecular Testing

Expertise Spanning Oncology and Beyond

Bio-Techne has partnered with pharma companies to provide precision medicine solutions across a wide range of disease areas, such as:

  • Neurodegenerative diseases
  • Cancer and immuno-oncology
  • Rare and complex genetic diseases
  • Autoimmune diseases
  • Genitourinary diseases
  • Infectious diseases

Complex Molecular Genetic Testing Made Simple

Asuragen’s AmplideX® testing technology accelerates the journey from Clinical Trial Assay (CTA) to Companion Diagnostics (CDx) by reliably amplifying GC-rich and other repetitive DNA sequences to develop treatments for specific gene types. This accomplishment is shown through partnerships such as:


Accelerating the Drug Development Journey

The QuantideX® technology can be adapted to monitor disease burden in diseases requiring highly sensitive detection and/or quantitation across multiple nucleic acid targets. It can also be utilized for designing high performing, efficient, and simplified kits for genetic targets with unmet biomarker development and CTA needs.

CDx Demonstrated Track Record of Success in Clinical Trial Assay Development

Together Transforming Companion Diagnostics

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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.

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As Targeted Therapies Expand Beyond Cancer, Companion Diagnostics...

When scientist originally debated the merits of sequencing an entire human genome, proponents argued that genomic data would potentially allow for more precise targeting of therapies to patients. Today, treatments tied to specific genomic variants – and the companion diagnostics needed to identify people with those variants – have transformed patient care.

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Partnership with Wave Life Sciences

Asuragen, a Bio-Techne brand, entered a partnership with Wave Life Sciences for the development and commercialization of companion diagnostics for Wave’s investigational allele-selective therapeutic programs targeting Huntington’s disease (HD).

Exosomes: New Standard in Multi-Analyte Liquid Biopsy Testing

Next-Generation Liquid Biopsies: Exosomes in Cancer Diagnostic Applications

Learn more about the use of exosomes as a diagnostic tool with a non-invasive and highly sensitive method for detecting cancer-specific biomarkers. Bio-Techne’s proprietary intellectual property related to exosomes allow us to streamline CDx services, from biomarker discovery to commercialization. 

Expanding CDx Opportunities Beyond Cancer: Stratifying Huntington's Disease Patients

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.

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World CDx: Driving Patient Enrollment Panel

Companion Diagnostics (CDx) have the potential to revolutionize the way we diagnose and treat diseases, by providing personalized information that is essential for the safe and effective use of a corresponding drug tailored to each patient's unique genetic profile.

Watch the panel discussion from World CDx Summit: “Driving Patient Enrollment and Stratification through a CDx Partnership” featuring Bernard Andruss (Head of Companion Diagnostics, Bio-Techne Inc.), Stephen Blakemore (VP, Biological & Translational Sciences, Accent Therapeutics, Inc), and Carly Campbell (Senior Scientist, Translational Science & Diagnostics, Bicycle Therapeutics)

Contact Us to Accelerate Your CDx Journey