Natera and BGI Genomics Announce Commercial Launch of the BGI/Natera Signatera Assay in China

Rhea-AI Summary

Natera, a leader in cell-free DNA testing, partners with BGI Genomics to launch the BGI/Natera Signatera Assay in China. This assay, which detects molecular residual disease in various cancers, enables earlier identification compared to standard imaging. Launched two years after their partnership, the assay supports innovative trial design and offers biopharmaceutical companies opportunities for companion diagnostic registrations in both China and the U.S. The collaboration aims to enhance precision medicine and improve treatment outcomes for cancer patients.

Positive

• Launch of BGI/Natera Signatera Assay in China enhances market presence.
• Assay identifies molecular residual disease earlier than standard imaging, potentially improving patient outcomes.
• Partnership with BGI allows for unique opportunities in global clinical trial services.
• Facilitates companion diagnostic registration in both China and the U.S.

Negative

• None.

AUSTIN, Texas and SHENZHEN, China, June 24, 2021 /PRNewswire/ -- Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA (cfDNA) testing, and BGI Genomics Co., Ltd., (300676.SZ), one of the world's leading genomics companies, today announced the launch of the BGI/Natera Signatera Assay which is now available to biopharmaceutical customers and clinicians across China.

Natera's Signatera^® assay, now offered in partnership with BGI,¹ has been utilized in numerous clinical studies across non-small cell lung, bladder, breast and colorectal cancers, to identify molecular residual disease (MRD) up to two years earlier than standard imaging. The test is now available in China under the Chinese brand name "华见微^®-肿瘤MRD定制化检测" - 华见微 (Hua Jian Wei for short).

"We're excited to bring this revolutionary technology to clinicians and patients in China," said John Fesko, chief business officer at Natera. "Partnering with BGI also enables Natera to offer our pharma partners truly global clinical trial services."

In March 2019, Natera and BGI Genomics entered into a partnership to commercialize Natera's Signatera test in China,¹ and after two years of technology transfers and validation, the BGI/Natera Signatera Assay (华见微) is now officially available in the country. The assay can help facilitate innovative trial design and enable biopharmaceutical researchers to make better informed and more timely decisions. Pharmaceutical companies can access this assay in China through the BGI-Natera partnership, which offers unique opportunities for companion diagnostic registration in both China and the U.S.

"BGI is committed to promoting precision medicine and cancer prevention with cutting-edge technologies. Signatera can detect recurrence earlier and help clinicians optimize treatment decisions, thus bringing greater survival benefits for patients. In partnership with Natera, we are pleased to introduce Signatera into China and provide this innovative technology that incorporates MGI sequencing platforms for clinical oncology and drug development in a reliable and affordable manner," said Shida Zhu, general manager of BGI Oncology.

About Natera

Natera is a pioneer and global leader in cell-free DNA testing from a simple blood draw. The mission of the company is to change the management of disease worldwide with a focus on women's health, oncology, and organ health. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas and San Carlos, California. It offers proprietary genetic testing services to inform obstetricians, transplant physicians, oncologists, and cancer researchers, including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit natera.com. Follow Natera on LinkedIn.

Natera 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, including obtaining regulatory approvals, 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.

About BGI Genomics

BGI was founded in 1999 with the vision of using genomics to benefit mankind and has since become one of the leading organizations in the genomics field. BGI Genomics is an independent division of BGI Group, and has been listed on the ChiNext of Shenzhen Stock Exchange since July 14, 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 DNBSEQ™ technology on the MGI sequencing platforms, economies of scale, and expert bioinformatics resources. BGI Genomics also offers a wide portfolio of transformative genetic testing products across major diseases, including pre-screening, screening, diagnosis and monitoring of cancer. BGI Oncology business unit operates ISO 27001-certified, CAP-accredited laboratory - Tianjin Medical Laboratory BGI. ^3,4 Till December 2020, BGI Oncology has established business cooperation relationship with more than 500 tertiary hospitals in China, and successfully performed cancer-related genetic tests on over 110,000 subjects. Follow BGI Genomics on LinkedIn and Twitter.

References:

1. https://www.natera.com/press-releases/natera-and-bgi-genomics-announce-50m-partnership-commercialize-signatera-oncology 
2. https://www.bgi.com/us/company/news/natera-bgi-genomics-announce-partnership/
3. https://investor.natera.com/news-releases/news-release-details/fda-grants-breakthrough-device-designation-nateras-signatera/
4. https://www.natera.com/company/news/fda-grants-two-new-breakthrough-device-designations-for-nateras-signatera-mrd-test/
5. https://oncology.bgi.com/huajianwei.html (in Chinese)
6. https://oncology.bgi.com/news_detail-192.html (in Chinese)

Natera Contacts

Investor Relations: Mike Brophy, CFO, Natera, 650-249-9090

Media: Kate Stabrawa, Communications, Natera, 720-318-4080

 

BGI Contacts

Media: Wendy Yan, Director of Marketing, BGI Oncology, BGI Genomics, yanweiqing@genomics.cn

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SOURCE Natera, Inc.

FAQ

What is the BGI/Natera Signatera Assay?

The BGI/Natera Signatera Assay is a test that detects molecular residual disease in various cancers, enabling earlier identification compared to standard imaging.

When was the BGI/Natera Signatera Assay launched?

The assay was officially launched on June 24, 2021, two years after the partnership between Natera and BGI Genomics.

What are the benefits of the Signatera Assay for cancer patients?

The Signatera Assay can lead to earlier detection of disease recurrence, helping clinicians make more informed treatment decisions, potentially improving survival rates.

How does the Natera and BGI partnership impact biopharmaceutical companies?

The partnership offers biopharmaceutical companies unique opportunities for companion diagnostic registration in both China and the U.S., enhancing clinical trial design.

What types of cancers does the Signatera Assay address?

The assay has been utilized in clinical studies for non-small cell lung, bladder, breast, and colorectal cancers.