Guardant Health Receives Medicare Coverage for Guardant Reveal™ on Smart Liquid Biopsy™ Platform for Surveillance Testing in Colorectal Cancer Patients
Guardant Health (Nasdaq: GH) announced Medicare coverage expansion for its Guardant Reveal test through Palmetto GBA. The coverage now includes surveillance testing for colorectal cancer (CRC) patients following curative intent therapy, expanding from the previous early post-surgical setting coverage.
The Guardant Reveal, running on the Smart Liquid Biopsy platform, is a blood-based test that uses epigenomic analysis to detect circulating tumor DNA (ctDNA) for minimal residual disease (MRD) monitoring. This tissue-free approach addresses the needs of cancer patients without available tissue specimens or those for whom tissue collection is challenging.
Of the 18 million cancer patients in the U.S. who could benefit from MRD testing, less than 3% currently receive it. Over 12 million cancer patients are more than five years post-surgery, making tissue specimen collection difficult, and over three million patients have no tumor tissue available.
Guardant Health (Nasdaq: GH) ha annunciato l'espansione della copertura Medicare per il suo test Guardant Reveal tramite Palmetto GBA. La nuova copertura include ora il monitoraggio per i pazienti con cancro colorettale (CRC) dopo terapie con intento curativo, estendendo la copertura precedente che era limitata solo al periodo immediatamente post-chirurgico.
Il Guardant Reveal, che utilizza la piattaforma Smart Liquid Biopsy, è un test basato su sangue che utilizza l'analisi epigenomica per rilevare il DNA tumorale circolante (ctDNA) per il monitoraggio della malattia residua minima (MRD). Questo approccio senza tessuto risponde alle esigenze dei pazienti affetti da cancro che non hanno campioni di tessuto disponibili o per i quali la raccolta di tessuto è difficile.
Dei 18 milioni di pazienti oncologici negli Stati Uniti che potrebbero beneficiare dei test MRD, meno del 3% attualmente li riceve. Oltre 12 milioni di pazienti oncologici sono più di cinque anni dopo l'intervento chirurgico, rendendo difficile la raccolta di campioni di tessuto, e oltre tre milioni di pazienti non hanno tessuto tumorale disponibile.
Guardant Health (Nasdaq: GH) anunció la expansión de la cobertura de Medicare para su prueba Guardant Reveal a través de Palmetto GBA. La cobertura ahora incluye pruebas de vigilancia para pacientes con cáncer colorrectal (CRC) después de terapias con intención curativa, ampliando la cobertura anterior que se limitaba al período postquirúrgico inmediato.
La Guardant Reveal, que utiliza la plataforma Smart Liquid Biopsy, es una prueba basada en sangre que utiliza el análisis epigenómico para detectar ADN tumoral circulante (ctDNA) para el monitoreo de enfermedad residual mínima (MRD). Este enfoque sin tejido aborda las necesidades de los pacientes con cáncer que no tienen muestras de tejido disponibles o para quienes la recolección de tejido es un desafío.
De los 18 millones de pacientes con cáncer en EE.UU. que podrían beneficiarse de las pruebas de MRD, menos del 3% las recibe actualmente. Más de 12 millones de pacientes con cáncer están más de cinco años después de la cirugía, lo que dificulta la recolección de muestras de tejido, y más de tres millones de pacientes no tienen tejido tumoral disponible.
가드란트 헬스 (Nasdaq: GH)는 Palmetto GBA를 통해 가드란트 리빌 테스트의 메디케어 커버리지 확대를 발표했습니다. 이 커버리지는 이제 치료적 의도를 가진 요법 후 대장암(CRC) 환자에 대한 감시 테스트를 포함하며, 이전에 수술 직후 설정된 커버리지에서 확장되었습니다.
가드란트 리빌은 스마트 액체 생검 플랫폼에서 실행되는 혈액 기반 테스트로, 순환하는 종양 DNA(ctDNA)를 감지하기 위해 에피게놈 분석을 사용하여 미세 잔여 질병(MRD) 모니터링을 수행합니다. 이 조직 비침습적인 접근 방식은 사용할 수 있는 조직 샘플이 없는 암 환자나 조직 수집이 어려운 환자의 요구를 해결합니다.
미국의 1800만 암 환자 중 MRD 테스트의 혜택을 받을 수 있는 환자는 3%도 안 됩니다. 1200만 명 이상의 암 환자는 수술 후 5년 이상 경과되어 조직 샘플 수집이 어려워지고 있으며, 300만 명 이상의 환자는 종양 조직을 보유하고 있지 않습니다.
Guardant Health (Nasdaq: GH) a annoncé une extension de la couverture Medicare pour son test Guardant Reveal par l'intermédiaire de Palmetto GBA. La couverture comprend désormais des tests de surveillance pour les patients atteints de cancer colorectal (CRC) après des thérapies à visée curative, élargissant ainsi la couverture précédente qui était limitée à la période post-chirurgicale précoce.
Le Guardant Reveal, qui fonctionne sur la plateforme Smart Liquid Biopsy, est un test basé sur le sang qui utilise l'analyse épigénomique pour détecter l'ADN tumoral circulant (ctDNA) pour la surveillance de la maladie résiduelle minimale (MRD). Cette approche sans tissu répond aux besoins des patients atteints de cancer pour lesquels il n'existe pas d'échantillons de tissu disponibles ou pour lesquels la collecte de tissu est difficile.
Parmi les 18 millions de patients cancéreux aux États-Unis qui pourraient bénéficier des tests de MRD, moins de 3 % en bénéficient actuellement. Plus de 12 millions de patients cancéreux ont plus de cinq ans post-chirurgie, ce qui rend la collecte d'échantillons de tissu difficile, et plus de trois millions de patients n'ont pas de tissu tumoral disponible.
Guardant Health (Nasdaq: GH) hat die Erweiterung der Medicare-Abdeckung für seinen Guardant Reveal-Test über Palmetto GBA angekündigt. Die Abdeckung umfasst nun Überwachungsuntersuchungen für Patienten mit kolorektalem Krebs (CRC) nach kurativer Therapie und erweitert sich damit von der vorherigen Abdeckung für die frühe postchirurgische Phase.
Der Guardant Reveal, der auf der Smart Liquid Biopsy-Plattform basiert, ist ein blutbasierter Test, der epigenomische Analysen verwendet, um zirkulierende Tumor-DNA (ctDNA) zur Überwachung von minimalen Restkrankheiten (MRD) zu erkennen. Dieser gewebefreie Ansatz kommt den Bedürfnissen von Krebspatienten entgegen, die über keine verfügbaren Gewebeschnitte verfügen oder bei denen die Gewebeentnahme schwierig ist.
Von den 18 Millionen Krebspatienten in den USA, die von MRD-Tests profitieren könnten, erhalten derzeit weniger als 3% diese. Mehr als 12 Millionen Krebspatienten sind mehr als fünf Jahre nach der Operation, was die Gewebesammlung erschwert, und über drei Millionen Patienten haben kein Tumorgewebe zur Verfügung.
- Medicare coverage expansion for Guardant Reveal test in CRC surveillance
- Addresses large untapped market with only 3% of 18M potential patients currently tested
- Blood-based testing eliminates need for tissue specimens, expanding addressable market
- None.
Insights
The Medicare coverage expansion for Guardant Reveal represents a significant market opportunity in the
The tissue-free approach is a game-changer, especially considering that 97% of eligible patients currently don't receive MRD testing. With 12 million cancer patients being over 5 years post-surgery and 3 million lacking tumor tissue samples, Guardant's blood-based testing solution removes significant barriers to access. The epigenomic analysis method used in Guardant Reveal offers earlier detection capabilities compared to traditional imaging, which could translate to improved patient outcomes and reduced healthcare costs.
For investors, this coverage decision is strategically important as it expands the addressable market beyond just post-surgical testing to include ongoing surveillance, potentially leading to recurring revenue streams per patient. The timing is optimal as the liquid biopsy market is projected to grow at a CAGR of
Medicare's coverage expansion through MolDX is a pivotal regulatory milestone that validates Guardant's technology and business model. This decision typically influences private payer policies, potentially leading to broader insurance coverage. The coverage for surveillance testing, beyond just post-surgical applications, creates a sustainable reimbursement pathway that could significantly impact Guardant's revenue cycle.
The timing aligns with increasing pressure to reduce healthcare costs while improving patient outcomes. Early detection of cancer recurrence through liquid biopsy can lead to more cost-effective interventions compared to managing advanced disease. For colorectal cancer patients specifically, this coverage decision removes financial barriers to accessing advanced diagnostics, potentially establishing a new standard of care in cancer surveillance.
- Blood test for minimal residual disease (MRD) now covered to monitor for disease recurrence after curative intent treatment
- Tissue-free approach addresses need for cancer patients who have no tissue available or for whom tissue specimens are difficult to obtain
As a result of this decision, the Guardant Reveal test is now covered for use in the CRC surveillance setting after curative intent treatment. This represents an expansion from the prior Medicare coverage of Guardant Reveal testing for CRC in the early post-surgical setting only.
“Utilizing ctDNA testing in the surveillance setting alongside standard of care monitoring, such as CT scans and CEA testing, has the potential to identify molecular recurrence of colorectal cancer ahead of traditional imaging,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “This important step by Medicare will make this testing more widely available to patients and support oncologists in making more informed therapeutic decisions.”
The tissue-free Guardant Reveal test uses a blood sample, in contrast to tumor-informed approaches to MRD testing, which require a healthcare provider to obtain a physical tissue specimen of the tumor. Of the 18 million total cancer patients in the
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.
* Sources: 1-2 Survival data from the Surveillance, Epidemiology, and End Results (SEER) Program; Tonorezos E, Devasia T, Mariotto AB, Mollica MA, Gallicchio L, Green P, Doose M, Brick R, Streck B, Reed C, de Moor JS, Prevalence of Cancer Survivors in
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Source: Guardant Health, Inc.
FAQ
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