BGI Genomics Program Seeks to Validate Signatera Test for Colorectal Cancer Patients in China

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NEW YORK – Building on an earlier licensing partnership, BGI Genomics and Natera have launched a clinical research program to use Signatera in China for colorectal cancer patients.
The BGI China multicenter program, which launched last week, is the first clinical research application of Natera\'s Signatera tumor-informed residual disease test in China for use with colorectal cancer patients.
Recent data published in Clinical Cancer Research showed that Signatera can be used to stratify colorectal cancer patients based on growth or stability of their circulating tumor DNA levels over time, and the firm has previously validated the approach for early detection and prediction of impending cancer recurrence.
In 2020, the test also received Medicare coverage in the US for patients with stage II to stage III colon cancer.
Natera and BGI Genomics\' partnership began when BGI saw the minimal residual disease test had been validated in the US and thought it would be beneficial to bring the technology to China for clinical practice, Shida Zhu, general manager of BGI Oncology, said. In June of this year, Signatera first became available to biopharmaceutical customers and clinicians in China under the brand name Hua Jian Wei.
Zhu said the firm waited to begin the clinical program until BGI had local production and delivery facilities available in China to perform the testing. It took two years to finish the facilities, he added, and Natera provided samples from its US-based production facilities to ensure the Chinese facilities were producing comparable results. Natera declined to comment on the partnership.
The data collected from the clinical program will allow clinicians to draft guidelines for applying the test in China. BGI has partnered with three hospitals across China — Fudan University Shanghai Cancer Center, the Second Affiliated Hospital Zhejiang University School of Medicine, and Sun Yat-sen University Cancer Center — to collect the information. Zhu said the company wanted the program to include hospitals in different regions in China and looked for sites that had interest in the test.

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