Guardant Health’s Shield Blood Test Now Covered for VA Community Care Beneficiaries
Guardant Health (Nasdaq: GH) announced that its Shield™ blood test for colorectal cancer screening is now covered by the U.S. Department of Veterans Affairs (VA) Community Care Network. The coverage applies to VA community care beneficiaries aged 45-84 with no copay requirement, marking the first coverage extension beyond Medicare beneficiaries.
The VA network coverage, which serves approximately 9.1 million beneficiaries, follows Medicare's coverage announcement in August 2024. This expansion particularly benefits individuals between 45-64 years old. The Shield blood test, which received FDA approval in July 2024 as the first blood test for primary CRC screening, also recently obtained Advanced Diagnostic Laboratory Test (ADLT) status from CMS.
Guardant Health (Nasdaq: GH) ha annunciato che il suo test del sangue Shield™ per lo screening del cancro colorettale è ora coperto dalla Rete di Assistenza Comunitaria del Dipartimento per i Veterani degli Stati Uniti (VA). La copertura si applica ai beneficiari dell'assistenza comunitaria della VA di età compresa tra 45 e 84 anni senza alcun costo aggiuntivo, segnando la prima estensione della copertura oltre i beneficiari di Medicare.
La copertura della rete VA, che serve circa 9,1 milioni di beneficiari, segue l'annuncio della copertura di Medicare nell'agosto 2024. Questa espansione beneficia in particolare gli individui tra i 45 e i 64 anni. Il test del sangue Shield, che ha ricevuto l'approvazione della FDA nel luglio 2024 come primo test del sangue per lo screening primario del CRC, ha recentemente ottenuto anche lo status di Test Diagnostico Avanzato di Laboratorio (ADLT) da CMS.
Guardant Health (Nasdaq: GH) anunció que su prueba de sangre Shield™ para la detección del cáncer colorrectal ahora está cubierta por la Red de Atención Comunitaria del Departamento de Asuntos de Veteranos de EE. UU. (VA). La cobertura se aplica a los beneficiarios de atención comunitaria de la VA de entre 45 y 84 años sin requisito de copago, marcando la primera extensión de cobertura más allá de los beneficiarios de Medicare.
La cobertura de la red de la VA, que atiende a aproximadamente 9.1 millones de beneficiarios, sigue al anuncio de cobertura de Medicare en agosto de 2024. Esta expansión beneficia especialmente a las personas de entre 45 y 64 años. La prueba de sangre Shield, que recibió la aprobación de la FDA en julio de 2024 como la primera prueba de sangre para la detección primaria del CRC, también obtuvo recientemente el estatus de Prueba de Laboratorio Diagnóstico Avanzado (ADLT) de CMS.
가드란트 헬스 (Nasdaq: GH)는 그들의 Shield™ 혈액 검사가 미국 재향군인부 (VA) 커뮤니티 케어 네트워크에 의해 대장암 검진을 위해 이제 보장된다고 발표했습니다. 이 보장은 45세에서 84세 사이의 VA 커뮤니티 케어 수혜자에게 적용되며, 추가 비용이 없으며, 메디케어 수혜자를 넘어선 첫 번째 보장 확장을 의미합니다.
약 910만 수혜자를 대상으로 하는 VA 네트워크의 보장은 2024년 8월 메디케어의 보장 발표에 이어서 이루어졌습니다. 이 확장은 특히 45세에서 64세 사이의 개인에게 혜택을 줍니다. Shield 혈액 검사는 2024년 7월 FDA 승인을 받았으며 대장암 검진을 위한 최초의 혈액 검사로 승인되었으며, 최근 CMS로부터 고급 진단 실험실 검사(ADLT) 지위를 획득했습니다.
Guardant Health (Nasdaq: GH) a annoncé que son test sanguin Shield™ pour le dépistage du cancer colorectal est désormais couvert par le Réseau de Soins Communautaires du Département des Anciens Combattants des États-Unis (VA). La couverture s'applique aux bénéficiaires de soins communautaires de la VA âgés de 45 à 84 ans sans exigence de co-paiement, marquant la première extension de la couverture au-delà des bénéficiaires de Medicare.
La couverture du réseau VA, qui sert environ 9,1 millions de bénéficiaires, fait suite à l'annonce de couverture de Medicare en août 2024. Cette expansion bénéficie particulièrement aux individus âgés de 45 à 64 ans. Le test sanguin Shield, qui a reçu l'approbation de la FDA en juillet 2024 en tant que premier test sanguin pour le dépistage primaire du CRC, a également récemment obtenu le statut de Test de Laboratoire Diagnostique Avancé (ADLT) de la part de CMS.
Guardant Health (Nasdaq: GH) gab bekannt, dass sein Shield™ Bluttest zur Früherkennung von Darmkrebs nun von dem Community Care Network des US-Veteranenministeriums (VA) abgedeckt wird. Die Abdeckung gilt für VA-Community-Care-Begünstigte im Alter von 45 bis 84 Jahren ohne Zuzahlungspflicht und stellt die erste Erweiterung der Abdeckung über Medicare-Begünstigte hinaus dar.
Die VA-Netzwerkabdeckung, die etwa 9,1 Millionen Begünstigte bedient, folgt der Bekanntgabe der Medicare-Abdeckung im August 2024. Diese Erweiterung kommt insbesondere Personen im Alter von 45 bis 64 Jahren zugute. Der Shield Bluttest, der im Juli 2024 von der FDA genehmigt wurde und der erste Bluttest zur primären CRC-Screening ist, hat kürzlich auch den Status eines Advanced Diagnostic Laboratory Test (ADLT) von CMS erhalten.
- First coverage expansion beyond Medicare to include younger population (45-64 years)
- Access to large VA network of 9.1 million potential beneficiaries
- No copay requirement for eligible individuals
- None.
Insights
This VA coverage decision marks a significant market access milestone for Guardant Health's Shield blood test. As the first non-Medicare coverage for this screening tool, it establishes an important precedent that could accelerate adoption across other payer systems.
The VA Community Care Network's 9.1 million beneficiaries represents a substantial new patient population, particularly valuable because it includes the first coverage for individuals aged 45-64. This younger demographic expansion is strategically important for long-term market penetration.
The decision to provide this as an in-network benefit with no copay removes financial barriers to adoption – critical for preventive screening technologies where patient cost-sharing often limits utilization. This zero-cost access model maximizes potential adoption rates among eligible veterans.
This coverage determination follows a logical progression of validation: FDA approval in July 2024, Medicare coverage in August 2024, and now VA network coverage. This sequential acceptance by federal healthcare authorities creates momentum that typically precedes broader commercial insurance adoption.
Guardant's Shield blood test represents a paradigm shift in colorectal cancer screening by offering a minimally invasive alternative to traditional methods. This VA coverage expansion could significantly impact screening compliance rates, historically challenging in preventive care.
The test's value proposition is particularly compelling for the veteran population, which may face barriers to colonoscopy procedures due to access challenges or medical contraindications. A simple blood draw dramatically lowers the screening threshold, potentially identifying cancers that would otherwise go undetected.
The expanded age range coverage (45-84) aligns perfectly with updated screening guidelines that lowered the recommended starting age from 50 to 45. Being first-to-market with coverage for this younger demographic (45-64) gives Guardant a competitive advantage in capturing this newly eligible screening population.
The timing is particularly advantageous as Shield received its Advanced Diagnostic Laboratory Test status from CMS recently, which typically supports favorable reimbursement positioning. This combination of regulatory approval, Medicare coverage, and now VA coverage within approximately eight months demonstrates exceptional market access execution and suggests strong clinical validation.
- US veterans and eligible family members now have access to blood test for colorectal cancer screening with no copay
- Benefit will cover all eligible individuals ages 45-84, representing first coverage beyond Medicare population for Shield
Following Medicare coverage for Shield in August 2024, the VA network coverage is the first for individuals between the ages of 45 and 64. The
“We are proud of the lifesaving value that the Shield blood test can bring to
The
The Shield blood test is FDA approved for primary non-invasive screening for colorectal cancer in average-risk individuals age 45 and older and can be ordered by any prescribing healthcare provider. For more information, visit www.ShieldCancerScreen.com.
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.
Guardant Health 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, 2024, 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. https://www.data.va.gov/dataset/VetPop2023-State-Data-6L/f43c-vb9n/data_preview
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Investor Contact:
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Media Contact:
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Source: Guardant Health, Inc.
FAQ
What is the coverage age range for Guardant Health's Shield blood test under VA care?
How many beneficiaries are covered under the VA Community Care Network for GH's Shield test?
When did Guardant Health (GH) receive FDA approval for the Shield blood test?
What recent regulatory achievements has GH's Shield test received?
