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Guardant Health, Inc. (Nasdaq: GH) is set to have the FDA Advisory Panel review its Shield™ blood test for colorectal cancer screening on May 23, 2024. The company aims to present clinical data from its ECLIPSE study, highlighting the potential of the Shield test to provide a more convenient and effective screening option for early detection of colorectal cancer, increasing treatment opportunities.
Guardant Health, Inc. (Nasdaq: GH) è pronta per la revisione del suo test sanguigno Shield™ per la scrematura del cancro colorettale da parte del Panel Consultivo della FDA il 23 maggio 2024. L'azienda intende presentare i dati clinici provenienti dal suo studio ECLIPSE, evidenziando il potenziale del test Shield di offrire un'opzione di screening più comoda ed efficace per la rilevazione precoce del cancro colorettale, aumentando le opportunità di trattamento.
Guardant Health, Inc. (Nasdaq: GH) está programada para que su prueba de sangre Shield™ para el cribado del cáncer colorrectal sea revisada por el Panel Asesor de la FDA el 23 de mayo de 2024. La compañía planea presentar datos clínicos de su estudio ECLIPSE, subrayando el potencial de la prueba Shield para proporcionar una opción de cribado más conveniente y efectiva para la detección temprana del cáncer colorrectal, incrementando las oportunidades de tratamiento.
가디언트 헬스, Inc. (Nasdaq: GH)는 2024년 5월 23일에 FDA 자문 패널이 대장암 선별을 위한 Shield™ 혈액 검사를 검토할 예정입니다. 이 회사는 ECLIPSE 연구에서의 임상 데이터를 제시할 계획이며, Shield 검사가 대장암의 조기 발견을 위해 보다 편리하고 효과적인 선별 옵션을 제공할 잠재력을 강조할 것입니다.
Guardant Health, Inc. (Nasdaq: GH) est prévue pour la révision de son test sanguin Shield™ pour le dépistage du cancer colorectal par le comité consultatif de la FDA le 23 mai 2024. La société prévoit de présenter les données cliniques de son étude ECLIPSE, mettant en lumière le potentiel du test Shield pour fournir une option de dépistage plus pratique et efficace pour la détection précoce du cancer colorectal, augmentant les opportunités de traitement.
Guardant Health, Inc. (Nasdaq: GH) steht vor der Überprüfung seines Shield™ Bluttests für das Screening von kolorektalem Krebs durch das FDA-Beratungsgremium am 23. Mai 2024. Das Unternehmen beabsichtigt, klinische Daten aus seiner ECLIPSE-Studie zu präsentieren, die das Potenzial des Shield-Tests hervorheben sollen, eine bequemere und effektivere Screening-Option für die frühzeitige Erkennung von Darmkrebs zu bieten und somit die Behandlungschancen zu erhöhen.
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PALO ALTO, Calif.--(BUSINESS WIRE)--
Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced the Molecular and Clinical Genetics Panel of the U.S. Food and Drug Administration Medical Devices Advisory Committee is scheduled to review the premarket approval (PMA) application for the company’s Shield™ blood test for colorectal cancer (CRC) screening on Thursday, May 23, 2024.
“We look forward to discussing with the FDA Advisory Committee and its panel of experts the clinical data from our ECLIPSE study and the potential for the Shield blood test to overcome the barriers of current screening methods and offer a new, more convenient screening option that will detect colorectal cancer in the early stages, when it is most treatable,” said AmirAli Talasaz, co-CEO of Guardant Health.
About Guardant Health
Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and helping doctors select the best treatment for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential utilities, values, benefits and advantages of Guardant Health’s liquid biopsy tests or assays, which involve risks and uncertainties that could cause the actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors. These and additional risks and uncertainties that could affect Guardant Health’s financial and operating results and cause actual results to differ materially from those indicated by the forward-looking statements made in this press release include those discussed under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operation” and elsewhere in its Annual Report on Form 10-K for the year ended December 31, 2023, and in its other reports filed with or furnished to the Securities and Exchange Commission thereafter. The forward-looking statements in this press release are based on information available to Guardant Health as of the date hereof, and Guardant Health disclaims any obligation to update any forward-looking statements provided to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based, except as required by law. These forward-looking statements should not be relied upon as representing Guardant Health’s views as of any date subsequent to the date of this press release.
When is the FDA Advisory Panel review of Guardant Health's Shield™ blood test for colorectal cancer screening scheduled?
The FDA Advisory Panel review is set to take place on May 23, 2024.
What is the purpose of the FDA Advisory Panel review for Guardant Health?
The review will evaluate the premarket approval (PMA) application for Guardant Health's Shield™ blood test for colorectal cancer screening.
What study data will Guardant Health present during the FDA Advisory Panel review?
Guardant Health will present clinical data from its ECLIPSE study during the review.
Who is the co-CEO of Guardant Health and what are their comments on the Shield™ blood test?
AmirAli Talasaz is the co-CEO of Guardant Health. He mentioned that the Shield blood test could offer a more convenient and effective screening option for early detection of colorectal cancer.
we believe conquering cancer is a big data problem. that’s why we built the world’s leading comprehensive liquid biopsy. this non-invasive tool for accessing and sequencing tumor dna is used by thousands of oncologists to help tens of thousands of advanced cancer patients. we believe the boom in cancer data acquisition we helped launch will drive important discoveries and new products. we’re working on some exciting ones, including in early detection, where the impact on patients can be profound. we’ve raised more than $500 million from investors including sequoia capital, khosla ventures, orbimed, and softbank.
