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Advanced Cell Diagnostics

SBIR Funding Helps Advance RNA Detection Technology Development, Enables Personalized Medicine

With Phase I Grant funding provided by the National Cancer Institute SBIR Development Center, Advanced Cell Diagnostics (ACD) completed the development of its RNAscope™ technology and is currently developing cell- and tissue-based diagnostic tests for personalized medicine focusing on cancer. SBIR funding has enabled this small company, based in Silicon Valley, CA, to prove the feasibility of single RNA molecule detection in situ, and to increase the size of the company by over 80%. This has significanty increased the resources available for its molecular pathology research program and will enable the commercialization of more cancer diagnostic technologies.

Picture of an application of the RNAScope(TM)
Figure 1. Application in cancer diagnostics: RNAscope™ can detect circulating tumor cells (CTC) in peripheral blood with excellent sensitivity and specificity. In addition, the molecular phenotype of the detected CTC can be identified at the same time.

“Using SBIR funding, my partner and I turned a concept into a world-leading technology and have a product on the market,” said Advanced Cell Diagnostic’s Founder, President & Chief Executive Officer Yuling Luo, Ph.D. “Now it’s a pretty significant business. We already have venture funding and 12 staff, including eight with Ph.D.s.”

In 2008, ACD launched the RNAscope™, which was initially used in the research market to detect RNA in situ on cell lines. The utility of the RNAscope™ technology has since been expanded to detect RNA in tissue specimens and for novel cancer diagnostic tests for breast, cervical, and head & neck cancer. Phase I and Phase II funding from the Multiplex Gene Expression in Single Cells for Circulating Tumor Cell (CTC) Detection grant will allow ACD to continue development of a technology for CTC detection and to develop an in vitro diagnostic test.

image of the RNAScope(TM)'s multiplexing capability
Figure 2. Multiplexing capability: RNAscope™ can detect several targets simultaneously. Each target can be a group of many different sequences.

ACD’s RNAscope™ technology is the first multiplex fluorescent and chromogenic in situhybridization platform capable of detecting and quantifying RNA biomarkers in a cell at single molecule sensitivity. It is currently the only effective technology platform capable of robust RNA detection in situ, which unlocks the full potential of RNA biomarkers for clinical diagnostic applications.

The driving force behind this technology was the need to address the heterogeneity of clinical specimens and enable the detection of nucleic acid biomarkers within a particular cell. The diagnostic assays based on RNAscope™ can detect diseases earlier and are more robust, precise, and information-rich, than was available prior to the development of this technology. This technology overcomes critical hurdles in the identification and validation of biomarkers for companion diagnostics.

How it works:

Click on the image to enlarge

Advancing Cancer Research

ACD’s products are molecular diagnostic tests for personalized cancer treatment, which is one of the fastest growing market sectors representing the future of cancer prevention, detection, and treatment. ACD’s efforts to develop Circulating Tumor Cells detection products, in particular, have enormous market potential because not only can each cancer patient be tested multiple times during different stages of cancer progression, but also the same approach is applicable to almost all forms of cancer.

Yuling Luo, Ph.D. shares, “Our Company is important to the cancer space for two main reasons. One aspect is that technology-wise, we fill an important void, and provide a viable in situ RNA detection technology. Second, clinically, in terms of cancer management, we will help fill a void in therapy selection and therapy response monitoring, for which there’s very few products out there in the market today.” While the current focus of development is therapy selection and therapy response monitoring, the application has potential to impact the full spectrum of cancer care.

“In the future, CTC technologies will one day enable the detection of cancer cells before they grow into invasive tumors,” said Yuling Luo, Ph.D. “They will also allow oncologists to determine earlier if a particular treatment is working and better select a treatment strategy.”

ACD plans to continue to develop partnerships with pharmaceutical and biotechnology companies to validate biomarkers for targeted therapy and to co-develop companion diagnostics.

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Reference to any specific commercial products, process, service, manufacturer, and/or company does not constitute an endorsement or recommendation by the National Cancer Institute (NCI), the NCI's Small Business Innovation Research (SBIR) & Small Business Technology Transfer (STTR) Programs, or any other portion of the U.S. Government.