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 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.
The program will use the ctDNA test to evaluate the effect of chemotherapy, immunotherapy, and targeted therapy on "hundreds of patients," Zhu said.
In addition, the program will focus on different subtypes of colorectal cancer in different patients, he said.
Once the program gets started, he said the project will likely expand to other hospitals and recruit more patients.
Zhu said the project is intended to help establish norms and standards in MRD testing in colorectal cancer patients by predicting recurrence and suggesting treatments. He added that BGI hopes to complete the trial in the first half of 2022.
Zhu also noted that this clinical validation project also aims to "continuously improve this technology to fit with cases in China." There has been a "surge in demand for clinical treatment" for colorectal cancer in the country due to increasing incidence that has made it the second most common cancer in the nation, Zhu said.
Most colorectal cancer cases in China are diagnosed at a late stage, and "the early information has become imperative, and also the monitoring is highly demanded," he said. "After we completed the localization of this technology, we had to speed up to collaborate with the experts and clinicians to put this study into reality."
"Thousands of clinicians are seeking … MRD products for their patients; we estimate there are maybe … hundreds of thousands of patients that can benefit from this test, and more from other cancers," he said.
Several companies claim they have the technology for MRD testing, but there is a lack of data supporting the claims, which is why BGI is working to validate Signatera, Zhu said.
"The lack of trials and official guidelines … hinders applying the MRD tests in China," he said. "Practitioners are not informed of which type of MRD test should be used."
While the program is starting with colorectal cancer patients, Zhu said BGI intends to expand it to other cancers, including lung, liver, and ovarian cancers. BGI's localized facilities are able to use Signatera for all types of cancer, but the firm needs to design clinical plans to validate the test for other cancers at other hospitals, he said.
Currently, BGI is searching for collaborators to perform clinical testing of Signatera with other cancers. The company plans to run these trials in parallel, rather than waiting for one to be finished before starting the next one, he said.
Each focus in a hospital is slightly different and has different purposes, requiring adjusted clinical designs, he said. The hospitals included in the program aren't paying for the tests, just providing resources for the patients, and BGI has invested "hundreds of thousands" of yuan into the project, Zhu said.
The test hasn't received regulatory clearance for clinical use in China, but BGI hopes to eventually seek it after showing that Signatera can improve treatment outcomes, Zhu said.
The firm has already received "hundreds" of research orders for the test, mostly from hospitals, and has exclusive rights to the test in China, Zhu said.
"We can leverage our knowledge and expertise to help prevent and treat colorectal cancer in China," he said.