Natera and BGI Genomics Announce $50M Partnership to Commercialize Signatera Oncology Test in China and to Develop Reproductive Health Tests in Select Markets on BGI’s DNBseq™ Technology Platform

SAN CARLOS, Calif. and SHENZHEN, China, March 11, 2019 /PRNewswire/ — Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA genetic testing, and BGI Genomics Co., Ltd., (300676.SZ), the largest cell-free DNA clinical testing laboratory in China and one of the world’s leading genomics companies, today announced a $50 million partnership to commercialize Natera’s Signatera™ MRD test in China, and to develop reproductive health tests in select markets on BGI’s sequencing instruments using the DNBseq™ NGS technology platform.

The Natera Signatera MRD and molecular monitoring test will be offered in China, first through specialty hospital networks and then more broadly, once Natera and BGI Genomics gain China’s regulatory approval for use of the Signatera test on the DNBseq™ technology platform. DNBseq™ is the market name of BGI’s proprietary sequencing technology, which supports its portfolio of next-generation sequencing platforms. BGI Genomics’ genetic testing leadership position in China, where it performs over 1 million cell-free DNA tests annually,¹ will accelerate Natera’s entry into this large and growing oncology market.

Cancer is the leading cause of death in China with roughly 4.3 million new cancer cases and 2.8 million deaths reported annually.² The molecular diagnostics market in China is a rapidly growing multi-billion-dollar market, driven largely by the rising incidence of cancer and infectious diseases.³

"Natera shares our core vision of improving human health by offering innovative genetic testing solutions that allow for earlier and more effective diagnosis of disease," said Yin Ye, CEO at BGI Genomics. "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. 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."

"We are very impressed with BGI’s pace of innovation, its people, and its scale of operations in China," said Steve Chapman, CEO at Natera. "BGI is a recognized world leader in next-generation sequencing and, we believe, the most qualified laboratory partner for us in China. 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."

"We are excited for the opportunity to partner with an innovative leader like BGI to commercialize Signatera in China and expand the reach of Natera’s reproductive health technology in select markets, and we believe BGI has the capability to substantially reduce costs for offering our technology," said John Fesko, Sr. Vice President of Business Development at Natera. "This deal complements our strategic partnerships with existing sequencing providers and does not alter our plans with them. This exciting alliance is key to our vision of being the application layer for genetic testing worldwide."

Financial Summary
Under the 10-year agreement, BGI Genomics will pay Natera $50 million in upfront licensing fees, prepaid royalties, and future milestone payments. Natera will also receive ongoing royalty payments. Natera will prepay BGI Genomics $6 million for sequencing services in connection with this partnership. 

About BGI
BGI was founded in 1999 with the vision of using genomics to benefit mankind and has since become one of the largest genomics organizations in the world. With a focus on research and applications in the healthcare, pharmaceutical, conservation and environmental fields, BGI has a proven track record of innovative, high-profile research that has generated over 1,600 publications. BGI Genomics is an independent division of BGI Group, and was listed on the Shenzhen Chi-Next exchange in July 2017. BGI Genomics’ goal is to make state-of-the-art genomics highly accessible to the global research community and clinical markets by integrating the industry’s broadest array of leading technologies, including BGI’s own DNBseq™ technology platforms, economies of scale, and expert bioinformatics resources. BGI Genomics also offers a wide portfolio of transformative genetic testing products across major diseases, enabling medical providers and patients worldwide to realize the promise of genomics-based diagnostics and personalized healthcare. Follow BGI Genomics on LinkedIn and Twitter.

About DNBseq™ Technology
DNBseq™ technology is a proprietary sequencing technology originally developed by Silicon Valley-based Complete Genomics, which was acquired by BGI in 2013.

DNBseq™ sequencing 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. This combination of linear amplification and DNB technology reduces the error rate while enhancing the signal. In addition, the size of the DNB is controlled in such a way that only one DNB is bound per active site in the flow cell. This patterned array technology not only provides sequencing accuracy, but it also increases the chip utilization and sample density. Unlike PCR amplification, amplification errors arising from Rolling Circle Amplification do not accumulate exponentially, allowing DNBseq™ platforms to deliver a high level of data clarity.

NGS data from DNBseq™ technology is documented by a growing body of studies, with over 100 peer-reviewed publications to date. BGI has also published pilot data from its sequencing platforms running on DNBseq™ technology, including samples processed for human whole genome sequencing from the UK Biobank as part of a proof of concept study.

About Signatera™
Signatera is the first circulating tumor DNA (ctDNA) test custom-built for molecular treatment monitoring and molecular residual disease (MRD) assessment. The test is available for research use only until its clinical launch planned for Q2 2019. The Signatera 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 tailored to match the clonal mutations found in that individual’s tumor tissue. This maximizes 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 also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies.

The body of evidence on the utility of Signatera is growing:

• A 2017 study demonstrated the Signatera RUO method’s ability to detect MRD, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care for early stage non-small-cell lung cancer (NSCLC) with 93 percent sensitivity and zero false positives.⁴
• Data presented at the European Society for Medical Oncology 2018 Congress 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.^5,6
• In two studies presented at the 2018 San Antonio Breast Cancer Symposium, 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.^7,8

Based on numerous studies across multiple cancer types, a positive Signatera RUO result without further treatment has predicted clinical relapse nearly 100 percent of the time.^4-8

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to change the management of disease worldwide. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform.

Forward-Looking Statements
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our or our partners’ efforts to develop and commercialize product offerings, whether standard closing conditions can be met, our partners’ ability to obtain regulatory approvals required to offer our products, our ability to improve, and the effect of any improvements in, our cost of goods sold, our ability to successfully increase demand for and grow revenues for our product offerings, whether the results of clinical studies will support the use of our product offerings, our expectations of the reliability, accuracy and performance of our screening tests, or of the benefits of our screening tests and product offerings to patients, providers and payers, or our expectations regarding our strategic operations. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Natera Contacts
Investor Relations: Mike Brophy, CFO, Natera, 650-249-9090
Media: Andrea Sampson, Sullivan & Sampson, 714-374–6174, asampson@sullivanpr.com

BGI Contacts
Investor Relations: Qian Xu, Secretary Board of Directors, BGI, +86-755-36307888
Media: USA and EMEA, Matt Poulter, Senior Global Marketing Manager, BGI Genomics, matt.poulter@bgi.com  
China and AP, Bicheng Yang, Director, Director Corporate Communications and Public Engagement, BGI Group, yangbicheng@genomics.cn

References

1. BGI internal figures as of 2019.
2. Chen W, Zheng R, Baade PD, et al. Cancer statistics in China, 2015. CA Cancer J Clin. 2016;66:115–132.
3. China Molecular Diagnostics Market, Volume, by Application [Oncology Testing (Breast Cancer, Colorectal Cancer, Prostate Cancer), Infectious Disease Testing (Virology, HPV), and Genetic Disease Testing (Blood Screening, HLA). 2018, Research and Markets Report, ID: 4607564.
4. Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446–451.
5. Birkenkamp-Demtröder K, Christensen E, Sethi H, et al. Sequencing of Plasma cfDNA from Patients with Locally Advanced Bladder Cancer for Surveillance and Therapeutic Efficacy Monitoring. Poster presented at: European Society for Medical Oncology Annual Congress; October 20, 2018; Munich, Germany. Abstract 86P.
6. Reinert T, Henriksen TV, Rasmussen MH, et al. Serial Circulating Tumor DNA Analysis for Detection of Residual Disease, Assessment of Adjuvant Therapy Efficacy and for Early Recurrence Detection in Colorectal Cancer. Poster presented at: European Society for Medical Oncology Annual Congress; October 21, 2018; Munich, Germany. Abstract 456PD.
7. Magbanua M, Brown-Swigart L, Hirst G, et al. Personalized serial circulating tumor DNA (ctDNA) analysis in high-risk early stage breast cancer patients to monitor and predict response to neoadjuvant therapy and outcome in the I-SPY 2 TRIAL. Data presented at spotlight session: San Antonio Breast Conference Symposium; December 5, 2018. Abstract 1259.
8. Coombes RC, Armstrong A, Ahmed S, Page K, et al. Early detection of residual breast cancer through a robust, scalable and personalized analysis of circulating tumour DNA (ctDNA) antedates overt metastatic recurrence. Poster presented at: San Antonio Breast Conference Symposium; December 7, 2018.  Abstract 1266.

SOURCE Natera