DeNovo Sciences is transforming the use of liquid biopsy in cancer diagnostics

Oct. 22, 2015

If you were explaining DeNovo Sciences to someone who is not familiar with the organization, how would you characterize its areas of expertise? What major categories of solutions does DeNovo provide for its customers? For many metastatic and recurrent cancers such as lung and prostate, procuring repeat biopsy samples is extremely challenging. Liquid biopsy can be a less invasive alternative in cases where patient monitoring can help with therapy decisions. DeNovo Sciences develops automated systems for rare circulating tumor cell (CTC) enrichment and single-cell molecular analysis. The Jetta400 system performs all the sample processing needed to isolate CTCs from whole blood and performs downstream molecular analysis of the captured CTCs including immunohistochemistry (IHC), DNA FISH, or mRNA FISH. The VanGuard system analyzes the prepared images of CTCs automatically. The innovative technology is intended to provide diagnostic information to the healthcare professional to help patients’ therapy selection and outcome.

The technology is currently used by basic life science and clinical researchers by CLIA labs. In some countries, it is being validated for clinical use, and we have begun the process for U.S. FDA submission.

Yixin Wang, PhD Chief Scientific Officer

DeNovo Sciences, CSO since July 2015; Ventana Medical Systems (a unit of Roche Diagnostics), VP, Molecular Probes Development; Executive Director, Research & Development; Pfizer, drug discovery
BS, Beijing University; PhD, Cornell University; Postdoctoral fellowship, Harvard Medical School

What role does liquid biopsy play in cancer diagnostics today? How might it be used in the future? There are two different approaches to less invasive blood-based liquid biopsies: circulating cell-free tumor DNA (ctDNA) and CTCs. While ctDNA can provide only information on DNA mutations, CTCs have the advantage of providing a complete picture of the whole cell, which includes protein, RNA and DNA analysis. Liquid biopsy uses blood or other body fluids to detect CTCs that have detached from solid tumors and entered the blood stream. Liquid biopsies may be used for cancer diagnosis, staging, prognosis, therapy selection, monitoring, and surveillance, and may, in the future, circumvent the need for invasive tumor biopsies.

What opportunities does microfluidic technology present to labs seeking to better serve their patients, or to increase their outreach? Microfluidic technology is in the forefront of oncology diagnostics. It has generated an impressive collection of medical devices, including diagnostic devices, in a few years. Many more such devices are being validated in clinical research, compared to standard-of-care procedures, and are on track to be used in the clinic for oncology diagnostics.

What are the advantages of CTCs to diagnosticians, compared to tissue biopsy? What challenges do CTCs present? Unlike tissue-based diagnostics, liquid biopsy is minimally invasive, fast, and less costly. CTC technologies can be as accurate as tissue-based diagnostics, and perhaps more useful because the testing can be performed on a more frequent basis. The challenge is enrichment of the rare CTC population and the ability to perform detailed single-cell morphological and genetic analysis of the captured cells. DeNovo’s label-free capture technology allows the researcher to customize results based on individual needs while ensuring maximum capture efficiency and high purity.

DeNovo’s products include the Jetta 100 platform for research and the Jetta 400 platform for clinical application. How does the Jetta 400 perform in the clinical lab? What do users need to know and do? Jetta400 is a fully-automated CTC preparation device that isolates and analyzes CTCs from blood samples without the need for preprocessing. It is a diagnostic device that not only allows the detection of one cancer cell in every 100 million in a single tube of blood, but also detects whether or not the CTCs present a therapeutic target. Isolation and downstream analysis are conducted on the same automated platform, ensuring a high level of reproducible and reliable results. It means that one could find and characterize cancer cells directly in the blood—essentially, comprehensive diagnostic by liquid biopsy.

What consumables are used with the Jetta 400 platform? The consumables for Jetta400 include a microfluidic chip designed and manufactured by DeNovo Sciences to isolate CTCs from a blood sample, as well as reagents required to capture and characterize CTCs using IHC, DNA FISH, and mRNA FISH.

You are a widely published scientist, a patent holder, and a former executive at major companies. How does an intimate knowledge of the science and technology help you function more effectively in your business capacity? DeNovo’s CTC technology is going to transform the use of liquid biopsy in cancer diagnostics. And we have lots to do. We will focus on delivering the best quality instrument so that it will help improve clinical laboratory operations and drive improved patient outcomes. My background and experience in development of IVD diagnostics will facilitate the business’s scientific and clinical applications. Liquid biopsy is a hot area in diagnostics and will evolve in the years to come, and we realize that other diagnostic companies may pursue a similar technology and application. We will be competing for time to market, intellectual property, product claims, and in many other areas. My job is to be proactive, and to build a strategic portfolio of products and competencies for our future