Skip to main content

Comprehensive Portfolio Across the Diagnostic Lifecycle

Molecular Diagnostic Kits

Molecular Kits

Kitted assays designed with proprietary chemistries and bioinformatics solutions to address unmet laboratory needs.

Quality Control

Controls & Reagents

Reliable controls and calibrators that ensure confidence, consistency, and compliance.

Development & Manufacturing

Development & Manufacturing

A trusted partner from concept to commercial scale with decades of diagnostic expertise.

Molecular Diagnostic Solutions for Clinical & Research Laboratories

Our genetics and oncology assay portfolios—AmplideX® and QuantideX®—combine proprietary chemistries, advanced bioinformatics, and integrated software to enable accurate, reproducible detection of complex genetic targets while simplifying laboratory workflows.

  • AmplideX technology delivers high sensitivity and specificity for hard-to-amplify sequences, leveraging long-read sequencing and consolidated workflows to provide deeper insight (including AGG interruptions in FMR1) and reduce the need for reflex testing.
  • QuantideX solutions extend this innovation into precision oncology, offering multiplex, ready-to-use assays with automated analysis that integrate seamlessly into existing lab infrastructure to enable scalable, high-throughput testing.

Together, our molecular solutions are engineered for the modern lab—reducing complexity, improving reproducibility, and accelerating adoption of advanced diagnostic technologies across inherited genetics, hematologic malignancies, and liquid biopsy applications.

Controls & Reagents for Clinical Diagnostics

A cornerstone of Bio-Techne Diagnostics is our comprehensive portfolio of quality controls and reagents—available off-the-shelf or customized in flexible formats—designed to streamline workflows, reduce error, and support applications from point-of-care to high-throughput and proficiency testing across key clinical disciplines.  

With deep customization capabilities, proprietary technologies, and mature design control processes, we accelerate assay development and reduce risk for clinical labs, diagnostic developers, and manufacturers. We support a broad range of clinical applications across both molecular and immunodiagnostics:  

  • Hematology
  • Clinical Chemistry & Immunodiagnostics
  • Critical Care (Blood Gas & CO-Oximetry)
  • Urine and Body Fluids
  • Molecular

Your Partner in Diagnostics Innovation

Bio-Techne Diagnostics brings more than 50 years of expertise in diagnostic development and manufacturing, combining global regulatory experience with deep insight into the needs of IVD developers and clinicians to solve complex challenges and advance patient care.  

Operating under cGMP and ISO 13485 quality systems, our global manufacturing capabilities deliver scalable, high-quality solutions—from formulation through fill, finish, and distribution—ensuring seamless transfer, tailored execution, and consistent performance at commercial scale.

 

 

A Unified Portfolio of Trusted Brands

Bio-Techne Diagnostics brings together a portfolio of specialized, industry-leading brands—each recognized for domain expertise—into a single, integrated partner:

 

 

  • Asuragen – Genetic and oncology molecular assays plus Armored molecular controls 
  • Bionostics – Blood gas and CO-Oximetry Glucose controls plus contract manufacturing 
  • BiosPacific – Antibodies, antigens, and conjugates 
  • Cliniqa – Clinical chemistry, urine controls and immunoassay development 
  • R&D Systems Clinical Controls – Hematology controls

 

Let’s build the next generation of diagnostics together.

 

Contact Us