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Natera Issues Statement on Guardant Health Litigation

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Natera has responded to a jury decision favoring Guardant Health in a false advertising case from 2021. The litigation involved mutual claims regarding statements about Guardant's Reveal test. Natera disagrees with the verdict and plans to appeal. The company emphasizes that the case focused solely on comparative advertisements from 2021 and does not affect their Signatera test, which has become the leading MRD test in the U.S., supported by over 100 peer-reviewed publications.

Natera ha reagito a una decisione della giuria a favore di Guardant Health in un caso di pubblicità ingannevole risalente al 2021. Il contenzioso includeva richieste reciproche riguardanti dichiarazioni sul test Reveal di Guardant. Natera non concorda con il verdetto e intende presentare ricorso. L'azienda sottolinea che il caso si è concentrato unicamente sulle pubblicità comparative del 2021 e non influisce sul loro test Signatera, che è diventato il test MRD leader negli Stati Uniti, supportato da oltre 100 pubblicazioni sottoposte a revisione paritaria.

Natera ha respondido a una decisión de un jurado a favor de Guardant Health en un caso de publicidad engañosa de 2021. El litigio involucró reclamaciones mutuas sobre declaraciones sobre la prueba Reveal de Guardant. Natera no está de acuerdo con el veredicto y planea apelar. La compañía enfatiza que el caso se centró únicamente en los anuncios comparativos de 2021 y no afecta su prueba Signatera, que se ha convertido en la prueba líder de MRD en EE. UU., respaldada por más de 100 publicaciones revisadas por pares.

네이터라는 2021년의 허위 광고 사건에서 가드란트 헬스에게 유리한 배심원 판결에 대응했습니다. 이 소송은 가드란트의 리빌 테스트에 대한 진술과 관련된 상호 주장을 포함했습니다. 네이터라는 판결에 동의하지 않으며 항소할 계획입니다. 이 회사는 이 사건이 2021년의 비교 광고에만 초점을 맞추고 있으며, 미국에서 주요 MRD 테스트로 자리 잡은 그들의 시그나테라 테스트에는 영향을 미치지 않는다고 강조합니다. 이 테스트는 100편 이상의 동료 검토 출판물로 뒷받침됩니다.

Natera a réagi à la décision d'un jury en faveur de Guardant Health dans une affaire de publicité mensongère datant de 2021. Le contentieux impliquait des revendications mutuelles concernant des déclarations sur le test Reveal de Guardant. Natera n'est pas d'accord avec le verdict et prévoit de faire appel. L'entreprise souligne que cette affaire a porté uniquement sur des publicités comparatives de 2021 et n'affecte pas leur test Signatera, qui est devenu le test MRD leader aux États-Unis, soutenu par plus de 100 publications évaluées par des pairs.

Natera hat auf das Urteil einer Jury reagiert, das zugunsten von Guardant Health in einem Fall von falscher Werbung aus dem Jahr 2021 entschieden hat. Der Rechtsstreit beinhaltete gegenseitige Ansprüche bezüglich Aussagen über den Reveal-Test von Guardant. Natera ist mit dem Urteil nicht einverstanden und plant Berufung. Das Unternehmen betont, dass der Fall ausschließlich auf vergleichende Werbung aus dem Jahr 2021 abzielte und keinen Einfluss auf ihren Signatera Test hat, der zum führenden MRD-Test in den USA geworden ist und von über 100 Fachartikeln unterstützt wird.

Positive
  • Signatera has achieved market leadership as the most widely used MRD test in the U.S.
  • Strong scientific validation with over 100 peer-reviewed papers across multiple cancer types
Negative
  • Lost false advertising lawsuit against Guardant Health
  • Legal expenses and potential damages from unfavorable jury verdict
  • Potential reputational impact from lawsuit loss

Insights

The jury verdict against Natera in the false advertising litigation with Guardant Health represents a significant legal setback. While Natera plans to appeal, such decisions often carry substantial financial implications through potential damages and legal costs. The case centered on comparative advertising claims about Guardant's Reveal test made in 2021, though the specific damages amount wasn't disclosed.

The litigation outcome could impact investor confidence and market perception, even though it doesn't directly challenge Natera's Signatera test technology or clinical validity. The company's defensive stance emphasizing Signatera's widespread adoption and scientific validation (100+ peer-reviewed papers) appears aimed at maintaining market confidence. However, the verdict may affect future marketing strategies and competitive positioning in the liquid biopsy market.

AUSTIN, Texas--(BUSINESS WIRE)-- Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA and genetic testing, today issued the following statement:

In 2021, Natera and Guardant Health filed false advertising cases against each other concerning statements both companies made more than three years ago about Guardant’s Reveal test. Today, a jury issued a decision in Guardant’s favor. We disagree with this decision and will ask the Court to overturn it.

The jury was asked to evaluate comparative advertisements that ran for a brief period in 2021 related to the performance of Guardant’s Reveal test. This case had nothing to do with the validity or utility of Signatera, and certain key pieces of evidence supporting Natera’s case were not included in this trial.

In the years that have passed since these events, Signatera has become the most widely used MRD test in the U.S., extensively validated with published evidence in more than 100 peer-reviewed papers across multiple cancer types and indications.

About Signatera

Signatera is a personalized, tumor-informed, molecular residual disease test for patients previously diagnosed with cancer. Custom-built for each individual, Signatera uses circulating tumor DNA to detect and quantify cancer left in the body, identify recurrence earlier than standard-of-care tools, and help optimize treatment decisions. The test is available for clinical and research use and is covered by Medicare for patients with colorectal cancer, breast cancer, ovarian cancer, and muscle-invasive bladder cancer, as well as for immunotherapy monitoring of any solid tumor. Signatera has been clinically validated across multiple cancer types and indications, with published evidence in more than 100 peer-reviewed papers.

About Natera

Natera™ is a global leader in cell-free DNA and genetic testing, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard of care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are validated by more than 250 peer-reviewed publications that demonstrate high accuracy. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California. For more information, visit www.natera.com.

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 whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. 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.

Investor Relations: Mike Brophy, CFO, Natera, Inc., 510-826-2350, investor@natera.com

Media: Lesley Bogdanow, VP of Corporate Communications, Natera, Inc., pr@natera.com

Source: Natera, Inc.

FAQ

What was the outcome of the false advertising lawsuit between Natera (NTRA) and Guardant Health in 2021?

The jury ruled in favor of Guardant Health regarding false advertising claims about Guardant's Reveal test. Natera disagrees with the decision and plans to appeal.

How has Natera's (NTRA) Signatera test performed in the market since 2021?

Signatera has become the most widely used MRD test in the United States, with validation from over 100 peer-reviewed papers across multiple cancer types and indications.

What is Natera's (NTRA) response to the jury verdict in the Guardant Health lawsuit?

Natera disagrees with the jury's decision and plans to ask the Court to overturn it, stating that key evidence supporting their case was not included in the trial.

Natera, Inc.

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