The Natera Signatera MRD and molecular monitoring test will be offered in
Cancer is the leading cause of death in
"We are very impressed with BGI's pace of innovation, its people, and its scale of operations in
"We are excited for the opportunity to partner with an innovative leader like BGI to commercialize Signatera in
Under the 10-year agreement,
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.
About DNBseq™ Technology
DNBseq™ technology is a proprietary sequencing technology originally developed by
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.
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 Oncology2018 Congressshowed 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
All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that
- BGI internal figures as of 2019.
- Chen W, Zheng R, Baade PD, et al. Cancer statistics in
China, 2015. CA Cancer J Clin. 2016;66:115–132.
- 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.
- Abbosh C, Birkbak NJ, Wilson GA, et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature. 2017;545(7655):446–451.
- 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.
- 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.
- 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.
- 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.
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