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CareDx Announces Closure of DOJ Investigation with No Finding of Wrongdoing

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CareDx, Inc. (Nasdaq: CDNA), a precision medicine company focused on transplant healthcare solutions, has announced the closure of a Department of Justice (DOJ) investigation with no finding of wrongdoing. The DOJ has declined to prosecute or take further action, as revealed in a Court document unsealed on October 7, 2024. This decision follows the U.S. Securities and Exchange Commission's (SEC) closure of its investigation in September 2023, also without taking any action against CareDx.

The investigations were related to a qui tam action filed by a former CareDx employee on February 12, 2021, in the federal district court for the Eastern District of New York. CareDx views these outcomes as validation that the allegations were meritless and reinforces confidence in its operational integrity. The company plans to vigorously defend itself if the former employee proceeds with litigation.

CareDx, Inc. (Nasdaq: CDNA), una società di medicina di precisione focalizzata su soluzioni sanitarie per trapianti, ha annunciato la chiusura di un'indagine del Dipartimento di Giustizia (DOJ) con nessuna constatazione di illeciti. Il DOJ ha deciso di non procedere con accuse o ulteriori azioni, come rivelato in un documento di corte reso pubblico il 7 ottobre 2024. Questa decisione segue la chiusura dell'indagine della Securities and Exchange Commission (SEC) degli Stati Uniti nel settembre 2023, anch'essa senza intraprendere azioni contro CareDx.

Le indagini erano collegate a un'azione qui tam presentata da un ex dipendente di CareDx il 12 febbraio 2021, presso il tribunale distrettuale federale per il Distretto Orientale di New York. CareDx considera questi esiti come una validazione del fatto che le accuse erano infondate e rafforza la fiducia nella propria integrità operativa. L'azienda intende difendersi vigorosamente qualora l'ex dipendente proceda con una causa legale.

CareDx, Inc. (Nasdaq: CDNA), una empresa de medicina de precisión centrada en soluciones de salud para trasplantes, ha anunciado el cierre de una investigación del Departamento de Justicia (DOJ) con ningún hallazgo de irregularidades. El DOJ ha decidido no procesar ni tomar más acciones, como se revela en un documento judicial desclasificado el 7 de octubre de 2024. Esta decisión sigue al cierre de la investigación de la Comisión de Bolsa y Valores (SEC) de EE. UU. en septiembre de 2023, también sin tomar ninguna medida contra CareDx.

Las investigaciones estaban relacionadas con una acción qui tam presentada por un ex empleado de CareDx el 12 de febrero de 2021, en el tribunal de distrito federal para el Distrito Este de Nueva York. CareDx considera estos resultados como una validación de que las acusaciones eran infundadas y refuerza la confianza en su integridad operativa. La empresa planea defenderse enérgicamente si el ex empleado prosigue con el litigio.

CareDx, Inc. (Nasdaq: CDNA)는 이식 헬스케어 솔루션에 초점을 맞춘 정밀 의료 회사로, 위법 발견 없음과 함께 법무부(DoJ) 조사 종료를 발표했습니다. DoJ는 기소하거나 추가 조치를 취하지 않기로 결정하였으며, 이는 2024년 10월 7일 공개된 법원 문서에서 밝혀졌습니다. 이 결정은 SEC(미국 증권거래위원회)가 2023년 9월에 CareDx에 대한 조사를 종료한 것과도 관련이 있습니다. 이 조사 또한 CareDx에 대한 어떤 조치도 취하지 않았습니다.

조사는 2021년 2월 12일 CareDx의 전 직원이 제출한 qui tam 소송과 관련이 있습니다. CareDx는 이러한 결과를 비난이 근거 없음을 입증하는 것으로 보고 있으며, 운영의 무결성에 대한 신뢰를 강화합니다. 회사는 전 직원이 소송을 진행할 경우 강력히 자신을 방어할 계획입니다.

CareDx, Inc. (Nasdaq: CDNA), une entreprise de médecine de précision spécialisée dans les solutions de santé liées aux greffes, a annoncé la clôture d'une enquête du Département de la Justice (DOJ) sans aucune constatation de fautes. Le DOJ a décidé de ne pas engager de poursuites ni de prendre d'autres mesures, comme le révèle un document judiciaire déclassifié le 7 octobre 2024. Cette décision fait suite à la clôture de l'enquête de la Securities and Exchange Commission (SEC) des États-Unis en septembre 2023, également sans aucune action contre CareDx.

Les enquêtes étaient liées à une action en qui tam déposée par un ancien employé de CareDx le 12 février 2021, devant le tribunal de district fédéral pour le district est de New York. CareDx considère ces résultats comme une validation que les allégations étaient sans fondement et renforce la confiance dans son intégrité opérationnelle. L'entreprise prévoit de se défendre vigoureusement si l'ancien employé poursuit une action en justice.

CareDx, Inc. (Nasdaq: CDNA), ein Unternehmen für präzise Medizin, das sich auf Gesundheitslösungen im Bereich Transplantation konzentriert, hat den Abschluss einer Untersuchung des Justizministeriums (DOJ) bekannt gegeben, ohne dass Fehlverhalten festgestellt wurde. Das DOJ hat beschlossen, keine Strafverfolgung einzuleiten oder weitere Maßnahmen zu ergreifen, wie aus einem am 7. Oktober 2024 veröffentlichten Gerichtsdokument hervorgeht. Diese Entscheidung folgt auf den Abschluss der Untersuchung durch die U.S. Securities and Exchange Commission (SEC) im September 2023, ebenfalls ohne Maßnahmen gegen CareDx zu ergreifen.

Die Ermittlungen standen im Zusammenhang mit einer Qui-Tam-Klage, die ein ehemaliger Mitarbeiter von CareDx am 12. Februar 2021 vor dem Bundesgericht für den östlichen Bezirk New York eingereicht hat. CareDx betrachtet diese Ergebnisse als Bestätigung dafür, dass die Vorwürfe unbegründet waren, und stärkt das Vertrauen in die betriebliche Integrität. Das Unternehmen plant, sich entschlossen zu verteidigen, falls der ehemalige Mitarbeiter Klage erhebt.

Positive
  • DOJ investigation concluded with no finding of wrongdoing
  • SEC investigation closed in September 2023 with no action taken
  • Company's confidence in operational integrity reinforced
Negative
  • None.

Insights

The closure of the DOJ investigation without any finding of wrongdoing is a significant positive development for CareDx. This outcome, coupled with the SEC's earlier decision to take no action, substantially strengthens the company's legal position and credibility. The qui tam action, while now unsealed, appears weakened by the government's decision not to intervene.

Key points to consider:

  • Two major federal agencies (DOJ and SEC) have now declined to pursue action against CareDx
  • This reinforces the company's assertion that the allegations were meritless
  • The legal risk profile for CareDx has improved significantly
  • Investor confidence may be bolstered by this resolution of regulatory scrutiny

However, it's important to note that the former employee could still pursue the qui tam action independently, which CareDx states it will "vigorously defend." While the immediate legal threat has diminished, ongoing litigation remains a possibility, albeit with reduced government backing.

The conclusion of the DOJ investigation without any adverse findings is likely to have a positive impact on CareDx's financial outlook and market perception. Key financial implications include:

  • Potential reduction in legal expenses and provisions related to the investigation
  • Improved investor sentiment, which could lead to a more favorable valuation
  • Enhanced ability to focus on core business operations without the distraction of a federal investigation
  • Possible positive impact on partnerships and customer relationships, as the cloud of suspicion is lifted

With a market cap of $1.7 billion, CareDx may see a near-term boost in stock price as the market digests this positive news. Long-term, the company's focus on precision medicine in the transplant sector remains its key value driver. Investors should monitor how CareDx leverages this legal victory to accelerate its business strategy and market position in the healthcare solutions space for transplant patients.

DOJ Concludes Investigation and Declines to Prosecute

BRISBANE, Calif.--(BUSINESS WIRE)-- CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that the Department of Justice (DOJ) has concluded its investigation into CareDx with no finding of wrongdoing and declined to take any further action.

In a Court document unsealed on October 7, 2024, the DOJ indicated that it is declining to intervene in a qui tam action filed by a former CareDx employee.

Today's decision by the DOJ follows the decision made by the U.S. Securities and Exchange Commission (SEC) in September 2023 to close its investigation and take no action against the Company. The Company believes the closure of the DOJ’s investigation underscores that the underlying allegations, which have now been reviewed by two separate government agencies, were meritless, reinforcing its confidence in the integrity of its operations.

The qui tam complaint, which was filed under seal on February 12, 2021, in the federal district court for the Eastern District of New York, is now unsealed. CareDx will continue to vigorously defend itself should the former employee choose to proceed with this litigation.

About CareDx – The Transplant Company

CareDx, Inc., headquartered in Brisbane, 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.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of applicable securities laws. These forward-looking statements are based upon information that is currently available to CareDx and its current expectations, speak only as of the date hereof, and are subject to numerous risks and uncertainties, all of which are difficult to predict and many of which are beyond our control, including whether the former employee of CareDx that initiated the qui tam action will pursue civil litigation and, if so, the outcome thereof, and other risks that are discussed in CareDx’s filings with the Securities and Exchange Commission (the “SEC”), including, but not limited to, the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 filed by CareDx with the SEC on February 28, 2024, the quarterly report on Form 10-Q for the quarter ended March 31, 2024 filed by CareDx with the SEC on May 9, 2024, the quarterly report on Form 10-Q for the quarter ended June 30, 2024 filed by CareDx with the SEC on July 31, 2024 and other reports that CareDx has filed with the SEC. Any of these may cause CareDx’s actual results, performance, or achievements to differ materially and adversely from those anticipated or implied by CareDx’s forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements. CareDx expressly disclaims any obligation, except as required by law, or undertaking to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.

CareDx, Inc.



Media Relations

Anna Czene

818-731-2203

aczene@caredx.com



Investor Relations

Greg Chodaczek

investor@CareDx.com

Source: CareDx, Inc.

FAQ

What was the outcome of the DOJ investigation into CareDx (CDNA)?

The Department of Justice (DOJ) concluded its investigation into CareDx (CDNA) with no finding of wrongdoing and declined to take any further action.

When did the SEC close its investigation of CareDx (CDNA)?

The U.S. Securities and Exchange Commission (SEC) closed its investigation of CareDx (CDNA) in September 2023, taking no action against the company.

What legal action was filed against CareDx (CDNA) and when?

A qui tam action was filed by a former CareDx employee on February 12, 2021, in the federal district court for the Eastern District of New York.

How does CareDx (CDNA) plan to respond if the former employee proceeds with litigation?

CareDx (CDNA) has stated that it will vigorously defend itself should the former employee choose to proceed with the litigation.

CareDx, Inc.

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