CareDx and Veracyte Announce Exclusive Partnership for Transplant Rejection Testing on nCounter System

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CareDx, Inc. CDNA and Veracyte, Inc. VCYT today announced an agreement through which CareDx will become the exclusive worldwide commercialization partner for solid organ transplant-rejection tests on the nCounter® FLEX Analysis System, Veracyte's diagnostic platform.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200514005297/en/

CareDx previously announced plans in September 2019 to develop HistoMap, a gene expression profiling solution to identify allograft rejection in transplant biopsy tissue. HistoMap will run on the nCounter FLEX Analysis System and will be developed using the Human Organ Transplant (HOT) panel from the Banff Foundation for Allograft Pathology. CareDx will be responsible for the global commercialization of HistoMap.

"With HistoMap added to our strong KidneyCare and HeartCare offerings, we will ensure that biopsies performed are reproducibly clinically relevant. This fits well into our approach of multimodality testing and patient stratification," said Peter Maag, Chairman and CEO of CareDx. "We are glad to partner with Veracyte to make these solutions available for transplant patients."

This agreement marks Veracyte's first diagnostics company partnership that is designed to expand the menu of genomic tests it offers on the nCounter instrument since acquiring the global diagnostic rights to the platform from NanoString Technologies in December 2019. In January 2020, Veracyte announced its first biopharmaceutical partnership – with Acerta Pharma, the hematology research and development arm of AstraZeneca – that was enabled by the NanoString transaction.

"We are pleased to partner with CareDx, a leader in transplant solutions with a track record of bringing innovative tools to clinical care," said Bonnie Anderson, Veracyte's Chairman and Chief Executive Officer. "We believe this agreement will expand the menu of advanced genomic tests we offer on the nCounter platform, helping us broaden the installed base of instruments and increase adoption of our tests in global markets. Ultimately, this collaboration helps us further achieve our vision of becoming a leading global provider of advanced genomic testing."

About CareDx

CareDx, Inc., headquartered in South San Francisco, California, is a leading precision medicine solutions company focused on the discovery, development and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers. CareDx offers testing services, products, and digital healthcare solutions along the pre- and post-transplant patient journey, and is the leading provider of genomics-based information for transplant patients. For more information, please visit: www.CareDx.com.

About Veracyte

Veracyte is a leading genomic diagnostics company that improves patient care by providing answers to clinical questions that inform diagnosis and treatment decisions without the need for costly, risky surgeries that are often unnecessary. The company's core products are uniquely developed with RNA whole-transcriptome sequencing and machine learning to deliver results that give patients and physicians a clear path forward. Since its founding in 2008, Veracyte has commercialized seven genomic tests and is transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis. In December 2019, Veracyte acquired the exclusive global diagnostic rights to the nCounter platform from NanoString Technologies, Inc., through which it plans to make its genomic tests available to physicians and their patients worldwide. These include commercial and in-development tests in breast cancer and lymphoma, respectively, which Veracyte also acquired through the transaction. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

Forward Looking Statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding expectations for CareDx's and Veracyte's partnership and the companies' ability to develop HistoMap and use the HOT panel and nCounter FLEX Analysis System to provide accurate diagnosis and avoid unnecessary biopsies. These forward-looking statements are based upon information that is currently available to CareDx and Veracyte, and their current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, including risks related to the successful execution of the partnership; risks of unexpected costs and delays associated with the partnership; general economic and market factors, including instability, costs and delays related to the recent COVID-19 outbreak; and other risks discussed in CareDx's and Veracyte's filings with the SEC, including their respective quarterly reports on Form 10-Q for the quarter ended March 31, 2020 filed by CareDx with the SEC on April 30, 2020 and filed by Veracyte with the SEC on May 6, 2020, and other reports that CareDx and Veracyte have filed with the SEC. Any of these risks may cause CareDx's or Veracyte's actual results, performance or achievements to differ materially and adversely from those anticipated or implied by these forward-looking statements. CareDx and Veracyte expressly disclaim any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements.

Veracyte, Afirma, Percepta, Envisia, Prosigna, LymphMark, and the Veracyte logo are trademarks of Veracyte, Inc. Other trademarks are the property of their respective owners.

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Posted In: Press Releases
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