Core lab Research Use Only products

Supporting continuous innovation in diagnostics.


Three Elecsys Research Use Only RUO kits for GFAP NfL and pT217 in front of a cobas e801 analytical system

Driving scientific progress through Research Use Only (RUO) products

Solution

Providing early access to innovative biomarkers to enhance diagnostic research

To manage today’s complex healthcare landscape and prepare for growing expectations for diagnostic testing, there is an urgent need for continuous innovation in diagnostics. However, a launched IVD assay can take years to become a standard of care, even with strong evidence of its benefits.

Our ‘Research Use Only’ (RUO) products portfolio delivers advanced, reliable tools and early access to cutting-edge technology, empowering researchers to explore the best possible future diagnostic solutions. By equipping scientists with innovative biomarkers now, we allow them to understand the benefits and potential use cases of new biomarkers earlier, enabling them to better understand disease biology, prepare laboratories in advance, and pave the way for upcoming IVD approvals leading to advanced healthcare practices. 

Value

Enabling better understanding of disease biology in high medical value areas

At Roche, as a leader in in vitro diagnostics, we are deeply committed to sustained innovation, as demonstrated by our industry-leading R&D investment. Research Use Only (RUO) products accelerate evidence generation and market acceptance of biomarkers not linked to a specific intended use.

Therefore, a key area of our investment is in the development of research use only medical devices to gain a better understanding of disease biology in critical high medical value areas such as:

  • Neurology
  • Oncology
  • Infectious diseases (ID)
  • Immunology
  • Cardiovascular disease

By addressing the unmet needs of today's patients, we are equipping scientists with the tools to explore innovative solutions, enhance disease understanding, and refine treatment guidelines, ultimately improving patient care

Vision

Empowering researchers to shape tomorrow’s diagnostics

Through RUO products, we ensure Roche stays at the forefront of research and enables scientists to gain insights into critical high-medical-value areas. We are committed to identifying additional biomarkers to advance scientific knowledge in areas like cardiac diseases and on MassSpec.

By enabling today's research, our RUO products are paving the way for improved patient outcomes and advanced healthcare practices tomorrow.

Featured products

The Elecsys GFAP RUO bx is an in vitro quantitative immunoassay for the measurement of GFAP in human serum, plasma and cerebrospinal fluid (CSF). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
The Elecsys NfL RUO assay is a quantitative immunoassay for the in vitro determination of neurofilament light (NfL) protein in human plasma, serum and cerebrospinal fluid (CSF). The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.
The Elecsys pT217p RUO is an in vitro quantitative immunoassay for the measurement of tau phosphorylated at amino acid 217 (pT217P) in human plasma. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Benefits of Core Lab Research Solutions from Roche

Early access

Gain early access to cutting-edge biomarkers

Roche’s RUO products portfolio delivers advanced, reliable tools and early access to cutting-edge technology that empower you to confidently drive critical breakthroughs and shape tomorrow’s diagnostics.

Our most developed area is neurology, where we provide a comprehensive panel for neurodegeneration research. We also have offerings in infectious diseases and are committed to extending our portfolio beyond these fields. We are actively working towards powerful RUO products for vital research in oncology, cardiometabolic conditions, women’s health, and immunology.

This expanding portfolio is the tangible result of our early access strategy. By making these diverse and innovative biomarkers available for your research now, we empower you to accelerate discovery and generate new insights, often years before a potential fully-validated IVD might become available.

Advanced assays

Achieve reliable results with highly specific and sensitive assays

Roche`s RUO products currently offer a comprehensive panel for neurodegeneration research, including key established biomarkers like:1-4

  • Elecsys® pT217 RUO: An in vitro quantitative immunoassay for the measurement of tau phosphorylated at amino acid 217 (pT217P) in human plasma.
  • Elecsys® ApoE4 RUO: A qualitative immunoassay for the in vitro determination of Apolipoprotein E4 (ApoE4) in human plasma.
  • Elecsys® GFAP: An in vitro quantitative immunoassay for the measurement of GFAP in human serum, plasma, and cerebrospinal fluid (CSF).
  • Elecsys® NfL: A quantitative immunoassay for the in vitro determination of neurofilament light (NfL) protein in human plasma, serum, and cerebrospinal fluid (CSF).
Biomarker research

Accelerate disease understanding with innovative assays

We are committed to further building our RUO products portfolio to support research and advance scientific knowledge across multiple critical disease areas, including oncology, cardiometabolic conditions, women’s health, and immunology. Some of the innovative biomarkers we are exploring for the future include:

  • Amyloid beta 42 (Aß42)*
  • Neuronal Pentraxin 2 (NPTX2)*
  • Chitinase-3-like protein 1 (YKL-40)*
  • Brain-derived tau (BD-tau)*
  • Soluble Triggering Receptor Expressed on Myeloid Cells 2 (sTREM2)*
  • Synaptosomal Associated Protein 25 (SNAP-25)*
  • Pro-surfactant protein B (Pro-SPB)*

Roche is not just a provider of laboratory research products such as advanced assays, but a dedicated partner. When a promising biomarker gains attention in the scientific community, we can offer it as an RUO, enabling you to harness these innovations and translate them into impactful scientific progress.

Workflow synergy

Perform RUO research on your existing Roche platforms

The Elecsys® RUO assays utilize electrochemiluminescence immunoassay (ECLIA) technology. They can be seamlessly integrated into your lab utilizing Roche’s automated cobas® e 801 and cobas® e 402 immunoassay analyzers.

Contact us

Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

*Product is in development and not commercially available.

Product availability may vary from country to country.

References

  1. F. Hoffmann-La Roche Ltd. Elecsys pT217 RUO Method Sheet. (v1.0). 2025.
  2. F. Hoffmann-La Roche Ltd. Elecsys ApoE4 RUO Method Sheet. (v1.0). 2025.
  3. F. Hoffmann-La Roche Ltd. Elecsys GFAP RUO Method Sheet. (v1.0). 2025.
  4. F. Hoffmann-La Roche Ltd. Elecsys NfL RUO Method Sheet. (v1.0). 2025.