Guardant Health Receives ADLT Status From CMS for Shield Blood Test
Guardant Health (Nasdaq: GH) has received Advanced Diagnostic Laboratory Test (ADLT) status from the Centers for Medicare & Medicaid Services (CMS) for its Shield™ blood test for colorectal cancer screening. The test, which received FDA approval in July 2024 as the first blood test for primary CRC screening, will be reimbursed at $1,495 for Medicare patients during the initial nine-month ADLT period starting April 1, 2025.
The ADLT status confirms Shield's innovative nature in providing novel clinical information unavailable through other methods. Following the initial period, Guardant Health will submit private-payer payment data, with the median rate determining Medicare pricing from January 1, 2026, to December 31, 2027. The Shield blood test is approved for primary non-invasive colorectal cancer screening in average-risk individuals age 45 and older.
Guardant Health (Nasdaq: GH) ha ricevuto lo status di Test Diagnostico Avanzato di Laboratorio (ADLT) dai Centri per Medicare e Medicaid Services (CMS) per il suo test del sangue Shield™ per lo screening del cancro colorettale. Il test, che ha ricevuto l'approvazione della FDA nel luglio 2024 come il primo test del sangue per lo screening primario del CRC, sarà rimborsato a $1,495 per i pazienti Medicare durante il periodo iniziale di nove mesi di ADLT che inizia il 1° aprile 2025.
Lo status ADLT conferma la natura innovativa di Shield nel fornire informazioni cliniche nuove non disponibili attraverso altri metodi. Dopo il periodo iniziale, Guardant Health presenterà dati sui pagamenti dei pagatori privati, con il tasso mediano che determinerà il prezzo di Medicare dal 1° gennaio 2026 al 31 dicembre 2027. Il test del sangue Shield è approvato per lo screening primario non invasivo del cancro colorettale in individui a rischio medio di età pari o superiore a 45 anni.
Guardant Health (Nasdaq: GH) ha recibido el estatus de Prueba de Laboratorio de Diagnóstico Avanzado (ADLT) de los Centros de Servicios de Medicare y Medicaid (CMS) para su prueba de sangre Shield™ para la detección del cáncer colorrectal. La prueba, que recibió la aprobación de la FDA en julio de 2024 como la primera prueba de sangre para la detección primaria de CRC, será reembolsada a $1,495 para los pacientes de Medicare durante el período inicial de nueve meses de ADLT que comienza el 1 de abril de 2025.
El estatus de ADLT confirma la naturaleza innovadora de Shield al proporcionar información clínica novedosa que no está disponible a través de otros métodos. Después del período inicial, Guardant Health presentará datos de pago de pagadores privados, siendo la tarifa mediana la que determinará el precio de Medicare desde el 1 de enero de 2026 hasta el 31 de diciembre de 2027. La prueba de sangre Shield está aprobada para la detección primaria no invasiva del cáncer colorrectal en individuos de riesgo promedio de 45 años o más.
Guardant Health (Nasdaq: GH)는 메디케어 및 메디케이드 서비스 센터(CMS)로부터 대장암 검진을 위한 Shield™ 혈액 검사에 대해 고급 진단 실험실 테스트(ADLT) 지위를 받았습니다. 이 검사는 2024년 7월에 FDA 승인을 받아 CRC(대장암) 검진을 위한 최초의 혈액 검사로, 2025년 4월 1일부터 시작되는 9개월의 ADLT 초기 기간 동안 메디케어 환자에게 $1,495로 환급될 예정입니다.
ADLT 지위는 Shield가 다른 방법으로는 얻을 수 없는 새로운 임상 정보를 제공하는 혁신적인 성격을 확인합니다. 초기 기간 이후, Guardant Health는 민간 보험 지급 데이터를 제출할 예정이며, 중위 요금이 2026년 1월 1일부터 2027년 12월 31일까지 메디케어 가격을 결정하게 됩니다. Shield 혈액 검사는 45세 이상의 평균 위험 개인을 위한 비침습적 대장암 검진에 승인되었습니다.
Guardant Health (Nasdaq: GH) a reçu le statut de Test de Laboratoire de Diagnostic Avancé (ADLT) des Centres de Medicare et Medicaid Services (CMS) pour son test sanguin Shield™ pour le dépistage du cancer colorectal. Le test, qui a reçu l'approbation de la FDA en juillet 2024 en tant que premier test sanguin pour le dépistage primaire du CRC, sera remboursé à $1,495 pour les patients Medicare pendant la période initiale de neuf mois de l'ADLT commençant le 1er avril 2025.
Le statut ADLT confirme la nature innovante de Shield en fournissant des informations cliniques nouvelles non disponibles par d'autres méthodes. Après la période initiale, Guardant Health soumettra des données de paiement des payeurs privés, le tarif médian déterminant le prix de Medicare du 1er janvier 2026 au 31 décembre 2027. Le test sanguin Shield est approuvé pour le dépistage primaire non invasif du cancer colorectal chez les personnes à risque moyen âgées de 45 ans et plus.
Guardant Health (Nasdaq: GH) hat vom Centers for Medicare & Medicaid Services (CMS) den Status eines Advanced Diagnostic Laboratory Test (ADLT) für seinen Shield™ Bluttest zur Früherkennung von Darmkrebs erhalten. Der Test, der im Juli 2024 als erster Bluttest zur primären CRC-Früherkennung von der FDA genehmigt wurde, wird während der ersten neunmonatigen ADLT-Phase ab dem 1. April 2025 mit $1,495 für Medicare-Patienten erstattet.
Der ADLT-Status bestätigt die innovative Natur von Shield, die neuartige klinische Informationen bietet, die durch andere Methoden nicht verfügbar sind. Nach der Anfangsphase wird Guardant Health Zahlungsdaten von privaten Zahlern einreichen, wobei der Medianpreis die Medicare-Preise vom 1. Januar 2026 bis zum 31. Dezember 2027 bestimmen wird. Der Shield Bluttest ist für die primäre nicht-invasive Früherkennung von Darmkrebs bei Personen mit durchschnittlichem Risiko ab 45 Jahren genehmigt.
- Received ADLT status from CMS, validating test's unique clinical value
- Medicare reimbursement rate set at $1,495 per test
- Strong adoption reported among Medicare-covered patient populations
- First FDA-approved blood test for primary CRC screening
- Final Medicare pricing after January 2026 remains uncertain, dependent on private-payer rates
Insights
Guardant Health securing ADLT status for its Shield blood test represents a significant financial catalyst with multiple positive implications. The
This development materially improves the commercial trajectory for Shield by addressing a critical component of diagnostic adoption - favorable reimbursement. With Medicare coverage already established and an FDA approval secured in July 2024, Guardant now has all three elements necessary for commercial success: regulatory approval, insurance coverage, and favorable pricing.
The market opportunity is substantial as colorectal cancer screening encompasses millions of Americans age 45+ annually. Blood-based testing addresses key compliance barriers of traditional screening methods like colonoscopy, potentially expanding the total market. The company's mention of "strong adoption" by Medicare providers signals encouraging early traction.
The April 2025 implementation date provides Guardant adequate runway to expand commercial infrastructure, with subsequent pricing to be determined by private payer rates through 2027. This improved reimbursement pathway strengthens the long-term economic model for one of Guardant's most important growth products.
The ADLT designation for Guardant's Shield test represents a milestone in CMS's approach to innovative cancer diagnostics. This status is selectively granted to tests providing unique clinical information unavailable through other methods or FDA-approved tests with significant clinical utility.
CMS's decision establishes a market-based pricing mechanism rather than fitting Shield into existing CPT codes, acknowledging the novel nature of the first FDA-approved blood test for primary colorectal cancer screening. The
The policy significance extends beyond pricing - this validation from CMS may accelerate broader insurance coverage, potentially improving screening compliance rates. Colorectal cancer screening compliance has historically been suboptimal, with approximately
The nine-month initial period followed by a market-based approach using private payer data demonstrates CMS's evolving approach to novel diagnostics. This flexible pricing model allows innovative tests to establish market value while ensuring Medicare beneficiaries gain access to breakthrough technologies. The policy approach balances innovation incentives with eventual market-based pricing mechanisms, creating a sustainable path for similar breakthrough diagnostics.
Approval demonstrates unique value of Shield test for CRC screening and improves Medicare pricing
The CMS determination confirms that the Shield test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method, and for FDA-approved tests. Obtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. The Shield test will be reimbursed at the amount of
During the initial ADLT period, Guardant Health will collect, assess and submit private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning January 1, 2026. This rate will be the payment amount for Shield from January 1, 2026, to December 31, 2027.
“Obtaining ADLT status reinforces the value that our Shield blood test for colorectal cancer screening brings to patients, offering a more pleasant and convenient option that can help increase the overall screening rate and improve outcomes,” said AmirAli Talasaz, Guardant Health co-CEO. “We’ve already seen strong adoption by providers with Medicare-covered patient populations. This designation from CMS and a more favorable Medicare rate will help us bring the innovation of Shield to more patients coast-to-coast by accelerating our investments in building our commercial infrastructure.”
The Shield blood test is FDA approved for primary non-invasive screening for colorectal cancer in average-risk individuals age 45 and older. 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, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250311660519/en/
Investor Contact:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Michael Weist
press@guardanthealth.com
+1 317-371-0035
Source: Guardant Health, Inc.
FAQ
What is the Medicare reimbursement rate for Guardant Health's Shield blood test?
When will Guardant Health's Shield test ADLT pricing period begin?
Who is eligible for the Guardant Health Shield blood test screening?
How long will the new Medicare pricing for GH's Shield test remain in effect?
