RNAscope® Technology and Pharma Assay Services in the drug development process

The flexible and scalable RNAscope® technology is an ideal companion for all your sample or target types, and various throughput needs for any step of your drug development project.

Understanding disease mechanism in preclinical research

Understanding the disease mechanism 

the underlying cause of a condition - is the first step in the potential development of a new therapeutic, and provides the information necessary for the identification of a “drugable” RNA or protein target. A complex mechanism will require access to multiple technologies, each providing complementary information to unravel the disease mechanism. RNAscope® technology has been demonstrated to be a complementary technology to NGS, qPCR or IHC by providing single RNA quantification in single cells while conserving the tissue context. It is particularly suited to genes with poor or unavailable antibodies, or for secreted proteins.

 

Target identification and validation

Identifying the target of a drug or a compound is a complex process that can involve multiple methods, tools, and technologies. 

RNAscope® is ideal for demonstrating expression of a target with cellular resolution, which can be correlated with disease state or progression. RNAscope® can also be used in in vitro models as well as animal models, lending itself to validation of targets in different systems.

Preclinical safety assessment and animal model studies

Once a compound is identified, a series of tests will determine its pharmacokinetics, pharmacodynamics and its toxicity and safety in different species. RNAscope® technology can be used to study the component itself, (if it’s an RNA molecule), or study the impact of the component on the target or other genes such as inflammatory cell markers or markers of cell death. RNAscope® is also perfectly suited for biodistribution studies in RNA-based therapeutics.

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Early clinical studies/ preclinical testing

RNAscope® can be used for retrospective analysis of patient samples, whether to evaluate correlation with drug response or disease progression. Archival samples can also be used, as RNAscope® has been successful used in samples up to 25 years old. The Pharma Assay Services team can work with you to set up receiving batched samples in ongoing clinical trials. RNAscope® is ideal for demonstrating expression of a target with cellular resolution, which can be correlated with disease state or progression. RNAscope® can also be used in in vitro models as well as animal models, lending itself to validation of targets in different systems.

Phase 1, 2 and 3-clinical trials

Drug safety and efficacy is validated using healthy candidates (phase 1) or patients (small cohort for phase 2, large cohort for phase 3).  RNAscope® technology provides an easy and scalable tool to process samples for patient stratification or analysis of drug effect on patient samples. Full automation on Leica’s or Ventana’s instrument allows analysis of up to 30 samples per day. Please note that ACD is not a CLIA-certified laboratory. However, we have partnered with service providers who offer RNAscope® services in a CLIA environment.

RNAscope® Technology and Pharma Assay Services for CDx development

Development of companion diagnostics have reduced the cost of bringing new therapeutics to the market. Our Pharma Assay Services, with their rapid development time, ease of use and the possibility to implement on IVD-marked instruments, can shorten your CDx development time and provide the assurance you need.

This year, Merrimack Pharmaceuticals selected RNAscope® ISH for its Phase 2 clinical trial of its drug candidate for metastatic non-small cell lung cancer, demonstrating the potential of RNAscope® technology as a companion diagnostic assay.

"We believe that the high sensitivity and specificity that RNAscope provides is necessary to identify the patients most likely to benefit from MM-121 in this Phase 2 clinical trial. RNAscope's ability to detect heregulin within the confines of tumor cells, compatibility with existing automation instruments and with small tissue specimens such as fine needle aspirates and core needle biopsies were all important considerations in our decision to work with ACD." 

Gavin MacBeath,
Senior Vice President of Translational Research at Merrimack
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