BGI Genomics plans to commercialize Natera’s Signatera molecular residual disease (MRD) test in China, and develop reproductive health tests in select markets on BGI's sequencing instruments, through a $50 million partnership announced by the companies this week.
In China, Natera and BGI Genomics said, the Signatera MRD and molecular monitoring test will be offered first through specialty hospital networks.
Signatera will be rolled out more broadly once the companies gain approval from Chinese regulators for use of Signatera on BGI’s DNBseq NGS technology platform, through which the reproductive tests will be developed.
According to Natera, Signatera is the first circulating tumor DNA (ctDNA) test custom-built for molecular treatment monitoring and MRD assessment. The test is available for research use only until its clinical launch planned for Q2 2019.
Signatera’s methodology differs from currently available liquid biopsy tests, which test for a fixed panel of therapeutically relevant genes. Signatera provides each individual with a customized blood test designed to match the clonal mutations found in that individual's tumor tissue, with the goal of maximizing accuracy for detecting the presence or absence of MRD in a blood sample, even at levels down to a single mutant molecule in a tube of blood.
Signatera RUO is also designed to enable researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies, Natera added. The company cites several studies showing successful results for Signatera:
- At the European Society for Medical Oncology 2018 Congress, Natera showed successful results from bladder and colorectal cancer studies, including median detection points of MRD that were 3.3 and 7.9 months, respectively, ahead of clinical relapse detection.
- At the 2018 San Antonio Breast Cancer Symposium, Natera presented results from two studies that reported Signatera RUO was able to detect MRD up to two years prior to clinical relapse and predict treatment response in a cross-section of breast cancer patients, including those who were HER-2 positive, hormone receptor-positive, and triple negative.
Natera reasons that its entry into China’s growing oncology market will be sped up by partnering with BGI Genomics, which says it performs more than 1 million cell-free DNA tests performed annually, making it a leading provider of genetic testing in the world’s most populous nation.
“We are very impressed with BGI’s pace of innovation, its people, and its scale of operations in China,” Natera CEO Steve Chapman said in a statement.
Developed by Complete Genomics—which BGI acquired in 2013 for $117.6 million—DNBseq is designed to support BGI Genomics’ portfolio of next-generation sequencing platforms.
The technology is powered by PCR-free Rolling Circle Replication, combinatorial Probe-Anchor Synthesis (cPAS) and DNA Nanoballs (DNB) technology. The cPAS chemistry works by linking a fluorescent probe to a DNA anchor on the DNB, followed by high-resolution digital imaging. According to BGI Genomics, the combination of linear amplification and DNB technology reduces the error rate while enhancing the signal.
In addition, the size of the DNB is controlled such that only one DNB is bound per active site in the flow cell—a patterned array technology that the company says not only provides sequencing accuracy, but also increases the chip utilization and sample density. Unlike PCR amplification, according to BGI, amplification errors arising from Rolling Circle Amplification do not accumulate exponentially, allowing DNBseq platforms to deliver a high level of data clarity.
“Natera’s decision to launch its Signatera test into China on BGI’s DNBseq technology platform is a testament to both the quality and versatility of our technology,” added BGI Genomics CEO Yin Ye. “We look forward to working together with Natera for the general benefit of people worldwide and to expanding access to the DNBseq technology platform to other customers globally.”
Under their 10-year partnership, BGI Genomics agreed to pay Natera $50 million in upfront licensing fees, prepaid royalties, and future payments tied to achieving milestones. Natera will also receive ongoing royalty payments.
Natera agreed to prepay BGI Genomics $6 million for sequencing services in connection with the partnership, disclosed by the companies on Monday.
“BGI is a recognized world leader in next-generation sequencing and, we believe, the most qualified laboratory partner for us in China,” Chapman added. “This deal continues Natera’s commercialization success in oncology, augmenting over 30 pharmaceutical trials currently underway, and is a strong endorsement of Natera’s leading technology in oncology and reproductive health.”