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ACD’s Biomarker Solution

In the world of personalized medicine, biomarkers play increasingly critical role in drug development. They:

  • serve as drug targets
  • evaluate efficacy or side effects
  • select right patients for clinical trial
  • enable earlier go/no go decisions in advancing a compound to the next phase

 

After the new drug or therapy is on the market, biomarkers form the bedrock of companion diagnostic tests that identify suitable patients for the therapy, predict outcome and monitor the progression.

 

It can be relatively easy to come up with candidate biomarkers. The hard part is to validate them. Due to the heterogeneity of diseases and patient population, evaluation of biomarker within the context of tissue structure has become increasingly important. The difficulty in developing effective in situ assays has emerged as a significant hurdle for biomarker validation, blocking the path to personalized medicine.

 

ACD’s RNAscope™ technology is a true toolset which can be used for any disease that involves changes in gene expression. It offers unprecedented flexibility that adapts and evolves with every step and turn of your drug development process. Custom assays for any RNA biomarkers can be developed within 3 weeks. More importantly, ACD guarantees the sensitivity and specificity of these assays, eliminating the risk in development timeline.

 

ACD provides clinical grade assay development and biomarker analysis services to speed up biomarker validation. ACD also partners with pharmaceutical and biotech companies to support clinical trials and turn validated biomarkers into successful companion diagnostic tests.

 

RNAscope™ can significantly accelerate biomarker validation
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RNAscope™ can help you to:

Even if an IHC assay is developed after considerable investment, the picked marker candidate may fail in clinical validation. You will be forced to select new candidate and start all over again.

 

All these difficulties translate into enormous resource and timeline risk in developing personalized medicine.

An RNAscope™ assay can be developed for your target within 3 weeks with GUARANTEED success. Multiplexed assay can also be accomplished in the same time frame.

 

This significantly reduces development risks and shortens the path to personalized medicine.

IHC assays are difficult to develop. Antibodies with good affinity and specificity are hard to come by. Assay conditions for each antigen-antibody pair is unique and time-consuming to optimize. Success is by no means guaranteed. Developing a multiplexed assay, if required, is even harder.

Using IHC for marker validation and eventual companion diagnostic test, the formidable costs associated with the assay development meant that you can only validate very limited few markers at a time.

With RNAscope™, you can afford to put all your biomarker candidates through the validation pipeline simultaneously.

The list of candidate biomarkers are normally generated at RNA level using gene expression profiling technologies, such as microarray, which may contain dozens of potentially applicable biomarkers for a particular clinical application.