Predicine Presents Worlds First Liquid Biopsy Test for Precision Medicine in Prostate Cancer

HAYWARD, CA--(Marketwired - Apr 19, 2016) - Predicine, Inc., an international precision medicine organization, presented data today demonstrating PrediSeq Prostate, the world's first next generation sequencing (NGS)-based blood test designed to detect drug resistance in particular, androgen-receptor splice variant 7 (AR-V7), for patients with advanced prostate cancer at the upcoming American Association for Cancer Research (AACR) Annual Meeting in New Orleans, LA.

Prostate cancer is the most common cancer and second leading cause of death in American men; it is also the fastest growing cancer type in developing countries like China. Abiraterone and enzalutamide are the current standard of care targeting androgen axis in castration-resistant prostate cancer (CRPC) and often used as the backbone in clinical trials testing the combination effect of investigative drugs for prostate cancer. However, most patients eventually relapse due to drug resistance to abiraterone and enzalutamide, which are often associated with genetic alterations of the androgen axis, such as mutations, amplification and splicing variants of AR.

Recent studies suggested that PCR-based detection of AR-V7 mRNA in circulating tumor cells (CTC) is associated with disease progression and shortened survival in prostate cancer patients. However, more than half of the CRPC patients do not have detectable CTCs, raising concerns and the request for complementary, non-CTC platforms to detect AR-V7. Furthermore, many mechanisms confer drug resistance, such as point mutations (AR, HSD3b), amplification of AR, and other splicing variants (AR-V9, AR-V567es). Currently, the AR-V7 PCR test has intrinsic limitations to capture other genetic alterations at one time.

PrediSeq Prostate blood test is based on Predicine's proprietary NGS platform and patented nucleic acid technology enabling sensitive, accurate and real-time detection of genetic alterations using circulating extracellular nucleic acids (ctRNA and ctDNA). The data will be presented at a poster session (Abstract #3161), Tuesday, April 19, 2016, entitled, "Development of a non-invasive NGS-based diagnostic test for precision medicine in prostate cancer," at AACR in New Orleans, LA. The presentation demonstrates the ability of the test to profile genomic alterations in prostate cancer, including splicing variants (such as AR-V7), point mutation, DNA damage, among others. PrediSeq Prostate test is currently undergoing clinical validation to assess its utility in genetic testing, disease monitoring and identification of drug resistance mechanism, with the goal of providing a comprehensive insight into the biology of the tumor and informing clinical decision making for patients with advanced prostate cancer.

The test will assist oncologists in identifying patients who may benefit from anti-hormone therapy among the population of CRPC patients whose tumors are metastatic and unavailable or who are unwilling or unable to undergo repeat biopsy. "Capturing AR-V7 in liquid biopsy is a major progress towards personalized cancer care for all CRPC patients regardless of their CTC status", said Shidong Jia, M.D., Ph.D., Founder and Chief Executive Officer of Predicine. He further added that it is important to "understand the presence and mechanism of drug resistance in order to fully evaluate the performance of investigative drugs in clinical trials."

"We're encouraged by the technology breakthrough and believe that our PrediSeq Prostate test, with its unique ability to analyze DNA and RNA (especially AR-V7) simultaneously, offer additional insight to help all CRPC patients, given the abundance of circulating extracellular nucleic acids," added Winston Patrick Kuo D.D.S., D.M.Sc, President of Predicine. "We are entering an aging society, where more men are likely to develop and live with prostate cancer during their lifetime. Non-invasive precision diagnostics and personalized disease management is the key to manage this chronic disease. We are committed to partnering with academic and industry leaders who share our vision of improving and innovating the global healthcare ecosystem."

About the Technology
RNAs are released into circulation from healthy, inflamed or diseased (cancerous) tissue from cells undergoing apoptosis or necrosis. Predicine's liquid biopsy technology assesses comprehensive molecular information about the tumor without direct access to the tissue. The company's platform is uniquely versatile, enabling the development of tests that can analyze either ctRNA alone or, simultaneously, ctDNA and ctRNA in a single test. In addition to PrediSeq Prostate test, Predicine also plans to launch liquid biopsy tests for lung cancer as well as other common cancer types.

About Predicine
Predicine, Inc based in Hayward, CA, is an international "big data" precision medicine organization that is committed to developing and commercializing the first- and best-in-class precision diagnostics, which includes a non-invasive cancer diagnostics solution, a comprehensive multiplex biomarker service platform and precision medicine portfolio to address the unmet medical needs in China and globally. Visit www.predicine.com to learn more.