HANGZHOU, China (February 5, 2024) — Adicon Holdings Limited, a leading independent clinical laboratory company, announced today that the first set of clinical trial samples has been tested using Guardant360®, marking the future readiness of access to comprehensive genomic profiling (CGP) testing using liquid biopsies for patients with cancer in China. Recently, its Shanghai Jince Medical Laboratory successfully completed Analytical Validation (AV) Studies of Guardant Health’s liquid biopsy test offered in China, confirming that the performance of the Guardant360 test in the Adicon laboratory is equivalent to Guardant Health’s US-based laboratory. The Guardant360 CDx test is the first fully localised CGP liquid biopsy solution with U.S. Food and Drug Administration (FDA) approval1.
“The laboratory compliance and standardisation of testing results instill confidence in biopharmaceutical companies that Guardant Health’s local offering of liquid biopsy offered in the Adicon laboratory is a high-quality, comprehensive genomic profiling test which can advance clinical research and accelerate development of new cancer therapies in China. The processing of the first batch of clinical trial samples in our local laboratory marks a significant milestone, as the Guardant360 test is a U.S. FDA-approved test available for clinical trials in China under global registration,” said Song Gao, CEO of Adicon.
Adicon is one of the top three independent clinical laboratory, or ICL. We offer comprehensive and best-in-class testing services primarily to hospitals and health check centres as well as central laboratory services to biopharma clients and contract research organizations through an integrated network of 36 self-operated laboratories across China. As of December 31, 2022, 18 of our laboratories were accredited by ISO15189, which enabled us to provide customers with the quality assurance that comes with this rigorous international standard. Our testing portfolio consists of over 4,000 medical diagnostic tests, including over 1,700 routine tests and over 2,300 esoteric tests, as of December 31, 2022. We are committed to continuously serving patients and the general public with our high-quality testing services as a leading ICL service provider in China and becoming a trusted and reliable partner for medical professionals and the general public.
1. FDA News Release. FDA approves first liquid biopsy next-generation sequencing companion diagnostic test. August 7, 2020. Accessed January 30, 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-liquid-biopsy-next-generation-sequencing-companion-diagnostic-test
Source: Adicon Holdings Limited.
Adicon Holdings Limited
See full press release in Chinese here: https://mp.weixin.qq.com/s/IMg7t-2rvZHnnguSxd8qWw