Guardant Health’s Shield™ Blood Test Approved by FDA as a Primary Screening Option, Clearing Path for Medicare Reimbursement and a New Era of Colorectal Cancer Screening
Guardant Health's Shield™ blood test has received FDA approval as a primary screening option for colorectal cancer (CRC) in adults aged 45 and older at average risk. This marks a significant milestone as the first blood test approved for CRC screening that meets Medicare coverage requirements. The test offers an easy and convenient alternative to traditional screening methods, potentially improving CRC screening rates.
Key points:
- Shield demonstrated 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia in the ECLIPSE study
- Over 90% adherence rate in real-world clinical settings
- Aims to address the gap in CRC screening rates, currently at 59% in the U.S.
- Potential to detect more cancers at an early stage when they are more treatable
Il test del sangue Shield™ di Guardant Health ha ricevuto l'
Punti chiave:
- Shield ha dimostrato un'83% di sensibilità per la rilevazione del CRC con una specificità del 90% per neoplasie avanzate nello studio ECLIPSE
- Oltre il 90% di adesione in contesti clinici reali
- Si propone di colmare il divario nei tassi di screening per il CRC, attualmente al 59% negli Stati Uniti
- Potenziale di rilevare più tumori in una fase iniziale, quando sono più trattabili
La prueba de sangre Shield™ de Guardant Health ha recibido la aprobación de la FDA como opción de detección primaria para el cáncer colorrectal (CCR) en adultos de 45 años o más con riesgo promedio. Esto marca un hito significativo como la primera prueba de sangre aprobada para la detección de CCR que cumple con los requisitos de cobertura de Medicare. La prueba ofrece una alternativa fácil y conveniente a los métodos de detección tradicionales, mejorando potencialmente las tasas de detección de CCR.
Puntos clave:
- Shield demostró un 83% de sensibilidad para la detección de CCR con un 90% de especificidad para neoplasias avanzadas en el estudio ECLIPSE
- Tasa de adherencia superior al 90% en entornos clínicos reales
- Busca abordar la brecha en las tasas de detección de CCR, actualmente en un 59% en EE. UU.
- Potencial para detectar más cánceres en una etapa temprana, cuando son más tratables
Guardant Health의 Shield™ 혈액 검사는 FDA 승인을 받았습니다 45세 이상 평균 위험 성인을 위한 대장암(CRC)의 주요 선별 옵션으로. 이는 CRC 선별을 위한 승인된 첫 번째 혈액 검사로, Medicare 보장 요건을 충족하는 중요한 이정표입니다. 이 검사는 전통적인 선별 방법에 대한 쉬운 편리한 대안을 제공하여 CRC 선별률을 개선할 수 있을 것으로 기대됩니다.
주요 사항:
- Shield는 ECLIPSE 연구에서 CRC 검출에 83%의 민감도와 고급 신생물에 90%의 특이성을 보여주었습니다.
- 실제 임상 환경에서 90% 이상의 순응률
- 현재 미국에서 59%인 CRC 선별률의 격차를 해소하는 것을 목표로 함
- 치료가 더 용이한 초기 단계에서 더 많은 암을 발견할 수 있는 잠재력
Le test sanguin Shield™ de Guardant Health a reçu l'
Points clés :
- Shield a démontré une sensibilité de 83 % pour la détection du CCR avec une spécificité de 90 % pour les néoplasies avancées dans l'étude ECLIPSE
- Taux d'adhérence de plus de 90 % dans des contextes cliniques réels
- A pour but de combler l'écart dans les taux de dépistage du CCR, actuellement à 59 % aux États-Unis
- Potentiel de détecter plus de cancers à un stade précoce, lorsqu'ils sont plus traitables
Der Shield™ Bluttest von Guardant Health hat die Zulassung der FDA als primäre Screening-Option für kolorektalen Krebs (CRC) bei Erwachsenen im Alter von 45 Jahren und älter mit durchschnittlichem Risiko erhalten. Dies stellt einen bedeutenden Meilenstein dar, da es der erste Bluttest ist, der für das CRC-Screening genehmigt wurde und die Anforderungen für die Medicare-Abdeckung erfüllt. Der Test bietet eine einfache und bequeme Alternative zu herkömmlichen Screening-Methoden und könnte die CRC-Screening-Raten potenziell verbessern.
Wichtige Punkte:
- Shield zeigte eine Empfindlichkeit von 83 % für die CRC-Erkennung mit einer Spezifität von 90 % für fortgeschrittene Neoplasien in der ECLIPSE-Studie
- Über 90 % Adhärenzrate in realen klinischen Umgebungen
- Ziel ist es, die Lücke bei den CRC-Screening-Raten zu schließen, die derzeit bei 59 % in den USA liegt
- Potenzial, mehr Krebserkrankungen in einem frühen Stadium zu erkennen, wenn sie besser behandelbar sind
- First FDA-approved blood test for primary CRC screening
- Meets Medicare coverage requirements
- 83% sensitivity for CRC detection, 90% specificity for advanced neoplasia
- Over 90% adherence rate in real-world clinical settings
- Potential to improve CRC screening rates and early detection
- Commercial insurance coverage pending future guideline inclusion
Insights
The FDA's approval of Guardant Health's Shield™ blood test as a primary screening option for colorectal cancer (CRC) marks a significant milestone in cancer diagnostics. With 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia, Shield's performance aligns with current guideline-recommended non-invasive screening methods. This approval could potentially revolutionize CRC screening practices.
The test's 90% adherence rate in real-world clinical settings is particularly noteworthy, especially when compared to the 28-71% adherence rates for traditional screening methods. This high compliance rate could significantly impact early detection rates, potentially improving patient outcomes. The test's ability to detect CRC in its early stages, where the five-year relative survival rate is 91%, could be a game-changer in reducing CRC-related mortality.
However, it's important to note that while Shield offers a convenient alternative, it doesn't replace the gold standard of colonoscopy for definitive diagnosis. Positive results from Shield would still require follow-up colonoscopy for confirmation and potential treatment. The test's role in detecting precancerous lesions, which is important for true prevention, needs further evaluation.
Guardant Health's FDA approval for Shield™ as a primary CRC screening option is a significant market opportunity. With over 50 million eligible Americans not completing CRC screening, Shield could capture a substantial portion of this untapped market. The test's convenience and high adherence rate position it favorably against existing screening methods.
The approval also paves the way for Medicare reimbursement, which is important for widespread adoption. As Shield meets the requirements for Medicare coverage, it opens up a significant revenue stream for Guardant Health. The potential inclusion in guidelines by the American Cancer Society and USPSTF could further boost commercial insurance coverage, expanding the addressable market.
However, investors should consider the competitive landscape. While Shield is the first FDA-approved blood test for primary CRC screening, other companies are developing similar technologies. Guardant Health's first-mover advantage could be significant, but maintaining market share will require continued innovation and marketing efforts.
The company's ability to scale up production and distribution to meet potential demand will be crucial. Additionally, the impact on Guardant Health's financials, including potential revenue growth and profitability timelines, will be key metrics to watch in upcoming quarters.
The approval of Shield™ could significantly disrupt the CRC screening market. With the U.S. CRC screening rate at only 59%, well below the National Colorectal Cancer Roundtable's 80% goal, Shield addresses a clear market need for more accessible and user-friendly screening options.
The test's convenience factor - requiring only a simple blood draw during a routine office visit - could be a major driver for adoption, especially among the 50 million eligible Americans who currently avoid screening due to the perceived invasiveness or unpleasantness of existing methods. This could lead to a substantial expansion of the overall CRC screening market.
However, market penetration will depend on several factors. Physician education and adoption will be crucial, as primary care doctors will need to be convinced of Shield's efficacy to prescribe it over established methods. Patient awareness and acceptance of a blood-based test for CRC screening will also play a key role in uptake.
The pricing strategy for Shield will be critical. While Medicare coverage is likely, the extent of commercial insurance coverage will significantly impact accessibility and adoption rates. Guardant Health's marketing approach, particularly in positioning Shield against existing screening methods, will be instrumental in shaping market perception and driving adoption.
Lastly, the potential for Shield to expand the overall CRC screening market, rather than just capturing market share from existing methods, could have far-reaching implications for public health and the oncology diagnostics industry as a whole.
- Shield is first blood test approved by FDA as a primary screening option for colorectal cancer and that meets performance requirements for Medicare coverage
- Blood test offers easy, convenient and pleasant screening option with potential for improving colorectal cancer screening rates
- Guardant Health to host investor conference call and webcast Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT
Shield is a blood test from Guardant Health for colorectal cancer screening in average-risk individuals 45 and older. (Photo: Business Wire)
Colorectal cancer is the second-leading cause of cancer-related death in the
The CRC screening rate in the
“The persistent gap in colorectal cancer screening rates shows that the existing screening options do not appeal to millions of people,” said Daniel Chung, MD, gastroenterologist at Massachusetts General Hospital and Professor of Medicine at Harvard Medical School. “The FDA's approval of the Shield blood test marks a tremendous leap forward, offering a compelling new solution to close this gap. This decision will help make screening tests more broadly accessible and propel blood-based testing and CRC screening into a new era. With increased screening rates and early cancer detection, many more lives can be saved.”
The Shield blood test is the result of over 10 years of research and development, including collaboration between Guardant Health and leading health organizations globally. Since the commercial introduction of the LDT (laboratory developed test) version in May 2022, the overall adherence rate for the Shield test has been more than
“The FDA approval of the Shield test is a significant victory for patients and an important milestone in Guardant Health’s mission to conquer cancer with data. Shield can help improve colorectal cancer screening rates so we can detect more cancers at an early stage, when they are treatable,” said AmirAli Talasaz, Guardant Health co-CEO. “We are now getting ready to launch this test in the near future and are very excited to empower physicians with a viable blood-based screening option to tailor the screening regimen to the unique needs of their patients.”
The FDA decision follows a strong recommendation for approval by an Advisory Committee panel in May 2024. The approval was based on results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Designed to reflect the diverse population of the
“In addition to performance, a screening test’s value should be measured by how accessible it is, and how likely people are to use it,” said Michael Sapienza, CEO of the Colorectal Cancer Alliance. “Guardant Health’s Shield test checks all three of these boxes and is truly a welcomed addition to the screening options currently available. Giving people choice, and offering a blood test that can reach those in harder-to-screen communities, will undoubtedly be a huge step forward in our battle against colorectal cancer.”
“This is a promising step toward making more convenient tools available to detect colorectal cancer early while it is more easily treated,” said William M. Grady, MD, a gastroenterologist at Fred Hutchinson Cancer Center. “The test, which has an accuracy rate for colon cancer detection similar to stool tests used for early detection of cancer, could offer an alternative for patients who may otherwise decline current screening options."
“Most people in my situation know we’re supposed to get screened for colon cancer,” said Dennis Barnes, a 55-year-old attorney whose physician had recommended a colonoscopy. But despite his best intentions, he had never scheduled one. “It’s hard to find the time to schedule it if you have a busy life and a demanding job,” he said. When his doctor told him about Shield, he agreed to have the blood test and was fortunate to have the result come back normal. “I realized I had taken quite a risk by waiting so long to screen. The Shield test is a much more pleasant way to screen, and the convenience of it makes getting screened pretty much a no-brainer.”
"I was in for a routine physical and my doctor asked when I had my last colonoscopy," said John Gormly, a 77-year-old business executive in
Shield is available for eligible individuals by prescription through a doctor or other healthcare professional and is expected to be covered for eligible Medicare beneficiaries. Commercial insurance coverage for patients eligible for CRC screening will continue to expand following anticipated future guideline inclusion by the American Cancer Society and the
For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.
Webcast Details
Guardant Health will host an investor conference call and webcast Monday, July 29, at 8:30 a.m. ET / 5:30 a.m. PT to discuss the FDA approval for Shield. A link to live audio of the webcast will be available on the “Investors” section of the company website at investors.guardanthealth.com or directly at this link. The webcast will be archived and available for replay after the event.
About Shield
Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.
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 and accelerating new cancer therapies 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 treatment selection 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 any current and periodic 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.
References
1. The Shield test meets performance requirements for Medicare coverage under NCD 210.3.
2. American Cancer Society. Key Statistics for Colorectal Cancer. Accessed online May 8, 2023. https://www.cancer.org/cancer/types/colon-rectal-cancer/about/key-statistics.html
3. American Cancer Society. Cancer Facts & Figures 2024.
4. Doubeni, C, et al. Modifiable Failures in the Colorectal Cancer Screening Process and Their Association with Risk of Death. Gastroenterology. 2019 Jan; 156(1): 63–74.e6.
5. American Society of Clinical Oncology. Colorectal Cancer: Statistics. https://www.cancer.net/cancer-types/colorectal-cancer/statistics#. Accessed April 23, 2024.
6. American Cancer Society National Colorectal Cancer Roundtable.
7. Rich T, Raymond V, Lang K. Where are we today? Efforts to understand strategies and barriers to physician issuance of a recommendation for colorectal cancer screening: a systematic review. Gastroenterology. 2020;158(6 suppl 1):S-918. doi:10.1016/S0016-5085(20)32981-4.
8. Raymond V, Foster G, Hong Y et al. Implementation of Blood-Based Colorectal Cancer Screening: Real-World Clinical Experience. ACG 2023 Annual Scientific Meeting Abstracts.
9. Denberg TD, Melhado TV, Coombes JM, et al. Predictors of nonadherence to screening colonoscopy. J Gen Intern Med. 2005;20(11):989-995.
10. Gellad ZF, Stechuchak KM, Fisher DA, et al. Longitudinal adherence to fecal occult blood testing impacts colorectal cancer screening quality. Am J Gastroenterol. 2011;106(6):1125-1134.
11. Inadomi JM, Vijan S, Janz NK, et al. Adherence to colorectal cancer screening: a randomized clinical trial of competing strategies. Arch Intern Med. 2012;172(7):575-582.
12. Exact Sciences. Third quarter 2019 webcast and conference call. Updated October 29, 2019. Accessed December 17, 2021. https:/investor.exactsciences.com/investor-relations/events-and-presentations/event-details/2019/Third-Quarter-2019-Webcast-Conference-Call/default.aspx
13. Chung DC, Gray DM, Singh H et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med 2024;390:973-83.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240725240089/en/
Investor Contact:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Mike Weist
press@guardanthealth.com
+1 317-371-0035
Source: Guardant Health, Inc.
FAQ
What is the Shield™ blood test by Guardant Health (GH) approved for?
How does the Shield™ test performance compare to other CRC screening methods?
What is the current colorectal cancer screening rate in the U.S., and how might Shield™ impact it?
When will Guardant Health (GH) launch the Shield™ blood test for CRC screening?
