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Guardant Health Introduces Major Smart Liquid Biopsy Upgrade to Market-Leading Guardant360® Test, Further Extending Its Best-in-Class Performance

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Guardant Health (NASDAQ:GH) has unveiled a major upgrade to its Guardant360 liquid biopsy test, running on the Guardant Infinity smart liquid biopsy platform. The enhanced test now covers 739 genes, a tenfold increase from its predecessor, and includes all guideline-recommended genomic biomarkers for advanced solid tumors. It offers 10 times higher sensitivity in quantifying tumor burden and can identify emerging biomarkers for precise cancer characterization.

Key features of the upgrade include:

  • Broader gene panel coverage
  • Analysis of both actionable and emerging biomarkers
  • Results delivered in 7-10 days
  • Medicare and major private payer coverage
  • Improved precision in treatment strategy identification

The test's expansion aims to provide oncologists with a more comprehensive view of cancer, potentially improving patient outcomes through more targeted treatment options.

Guardant Health (NASDAQ:GH) ha svelato un importante aggiornamento al suo test di biopsia liquida Guardant360, che utilizza la piattaforma intelligente di biopsia liquida Guardant Infinity. Il test potenziato ora copre 739 geni, un aumento di dieci volte rispetto al suo predecessore, e include tutti i biomarcatori genomici raccomandati dalle linee guida per i tumori solidi avanzati. Offre una sensibilità dieci volte superiore nella quantificazione del carico tumorale e può identificare biomarcatori emergenti per una precisa caratterizzazione del cancro.

Le caratteristiche principali dell'aggiornamento includono:

  • Copertura più ampia del pannello genico
  • Analisi di biomarcatori sia azionabili che emergenti
  • Risultati consegnati in 7-10 giorni
  • Copertura Medicare e da parte dei principali pagatori privati
  • Precisione migliorata nell'identificazione delle strategie di trattamento

L'espansione del test mira a fornire agli oncologi una visione più completa del cancro, potenzialmente migliorando gli esiti dei pazienti attraverso opzioni di trattamento più mirate.

Guardant Health (NASDAQ:GH) ha presentado una gran actualización de su prueba de biopsia líquida Guardant360, que se realiza en la plataforma inteligente de biopsia líquida Guardant Infinity. La prueba mejorada ahora cubre 739 genes, un aumento de diez veces respecto a su predecesora, e incluye todos los biomarcadores genómicos recomendados por las directrices para tumores sólidos avanzados. Ofrece una sensibilidad diez veces mayor en la cuantificación de la carga tumoral y puede identificar biomarcadores emergentes para una caracterización precisa del cáncer.

Las características clave de la actualización incluyen:

  • Mayor cobertura del panel de genes
  • Análisis de biomarcadores tanto accionables como emergentes
  • Resultados entregados en 7-10 días
  • Cobertura de Medicare y de los principales pagadores privados
  • Mejor precisión en la identificación de estrategias de tratamiento

La expansión de la prueba tiene como objetivo proporcionar a los oncólogos una visión más completa del cáncer, mejorando potencialmente los resultados de los pacientes a través de opciones de tratamiento más dirigidas.

가드란트 헬스(Gardant Health, NASDAQ:GH)는 가드란트360 액체 생검 검사에 대한 주요 업그레이드를 발표했습니다. 이 검사는 가드란트 인피니티(Gardant Infinity) 스마트 액체 생검 플랫폼에서 실행됩니다. 향상된 검사로는 739개의 유전자를 다루게 되었으며, 이는 이전 검사보다 10배 증가한 수치입니다. 이 검사에는 고급 고형 종양에 대한 모든 가이드라인 추천 유전체 바이오마커가 포함되어 있습니다. 이 검사는 종양 부담을 정량화하는 데 있어 10배 높은 감도를 제공하며, 정밀한 암 특성을 위해 새로운 바이오마커를 식별할 수 있습니다.

업그레이드의 주요 특징은 다음과 같습니다:

  • 확장된 유전자 패널 커버리지
  • 실행 가능한 바이오마커 및 신흥 바이오마커 분석
  • 7-10일 내 결과 제공
  • 메디케어 및 주요 민간 보험사 커버리지
  • 치료 전략 식별의 정밀도 향상

검사의 확장은 온콜로지스트에게 암에 대한 보다 포괄적인 관점을 제공하여, 보다 구체적인 치료 옵션을 통해 환자 결과를 개선하는 것을 목표로 합니다.

Guardant Health (NASDAQ:GH) a dévoilé une mise à jour majeure de son test de biopsie liquide Guardant360, qui fonctionne sur la plateforme intelligente de biopsie liquide Guardant Infinity. Le test amélioré couvre désormais 739 gènes, soit une augmentation par dix par rapport à son prédécesseur, et inclut tous les biomarqueurs génomiques recommandés par les directives pour les tumeurs solides avancées. Il offre une sensibilité dix fois supérieure dans la quantification de la charge tumorale et peut identifier des biomarqueurs émergents pour une caractérisation précise du cancer.

Les principales caractéristiques de la mise à jour incluent :

  • Couvre un panel génétique plus large
  • Analyse des biomarqueurs à la fois actionnables et émergents
  • Résultats livrés en 7 à 10 jours
  • Couverture Medicare et des principaux assureurs privés
  • Précision améliorée dans l'identification des stratégies de traitement

L'expansion du test vise à fournir aux oncologues une vue plus complète du cancer, ce qui pourrait améliorer les résultats des patients grâce à des options de traitement plus ciblées.

Guardant Health (NASDAQ:GH) hat ein bedeutendes Upgrade für seinen Guardant360 Liquid Biopsy Test vorgestellt, der auf der Guardant Infinity smart Liquid Biopsy-Plattform läuft. Der verbesserte Test umfasst nun 739 Gene, eine zehnfache Steigerung im Vergleich zu seinem Vorgänger, und enthält alle von den Richtlinien empfohlenen genomischen Biomarker für fortgeschrittene solide Tumore. Er bietet eine zehnmal höhere Empfindlichkeit bei der Quantifizierung der Tumorlast und kann auftretende Biomarker zur präzisen Krebscharakterisierung identifizieren.

Wichtige Merkmale des Upgrades beinhalten:

  • Erweiterte Genpanel-Abdeckung
  • Analyse sowohl handlungsrelevanter als auch aufkommender Biomarker
  • Ergebnisse werden in 7-10 Tagen geliefert
  • Medicare- und große Privatversicherungsdeckung
  • Verbesserte Präzision bei der Identifizierung von Behandlungsstrategien

Die Erweiterung des Tests zielt darauf ab, Onkologen eine umfassendere Sicht auf Krebs zu bieten, was potenziell die Patientenergebnisse durch gezieltere Behandlungsoptionen verbessern kann.

Positive
  • Tenfold increase in gene coverage (739 genes) for more comprehensive cancer profiling
  • 10 times higher sensitivity in quantifying tumor burden
  • Includes all guideline-recommended genomic biomarkers for advanced solid tumors
  • Covered by Medicare and major private insurers
  • Faster results delivery in 7-10 days
  • Potential for improved patient outcomes through more targeted treatment options
Negative
  • None.

As an Oncology Doctor, I can see the tremendous potential of the upgraded Guardant360 test. The inclusion of biomarkers from 739 genes, alongside all guideline-recommended genomic biomarkers, is a significant leap in the precision oncology field. The ability to identify emerging biomarkers also opens new avenues for future treatment plans, providing oncologists with the tools to personalize treatment strategies more effectively. Additionally, the increased sensitivity in quantifying tumor burden means we can now detect disease progression earlier and more accurately, potentially leading to better patient outcomes. This upgrade represents a notable advancement in comprehensive cancer profiling and it could set a new standard for liquid biopsies moving forward.

From a financial perspective, the upgraded Guardant360 test is a strategic move for Guardant Health. Expanding the test's gene panel to include 739 genes not only enhances its market competitiveness but also positions it as the most comprehensive liquid biopsy available. The Medicare and major private payers' coverage ensures a significant addressable market, ultimately driving revenue growth. Given that the test has already been adopted by over 15,000 oncologists and is supported by extensive peer-reviewed publications, this upgrade could further solidify Guardant Health's market leadership and translate into strong financial performance in the coming quarters.

The introduction of the upgraded Guardant360 test on the Guardant Infinity platform marks a key development in the liquid biopsy market. The test's ability to analyze a broader range of both actionable and emerging biomarkers distinguishes it from competitors, offering a unique value proposition. By providing results within 7 to 10 days, it meets the clinical need for timely information, which can be critical in cancer treatment decisions. The extensive coverage, including Medicare and major insurers, ensures widespread accessibility. This upgrade is likely to enhance Guardant Health's competitive edge and market share in the precision oncology space, especially considering the growing demand for comprehensive genomic profiling in cancer care.

  • Running on Guardant Infinity™ smart liquid biopsy platform, new Guardant360 test covers over 10 times more genes, including all guideline-recommended genomic biomarkers across advanced solid tumors, and quantifies tumor burden with 10 times higher sensitivity
  • Upgraded test covered by Medicare and major private payers for comprehensive genomic profiling of all advanced solid tumors

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (NASDAQ:GH), a leading precision oncology company, today announced the launch of a major upgrade to its market-leading Guardant360 liquid biopsy test. The new enhanced test evaluates biomarkers in 739 genes in total, which is 10 times more cancer biomarkers than the previous version of Guardant360 evaluated. The test can also identify an extensive array of emerging biomarkers to precisely characterize cancer and can quantify disease burden at much higher sensitivity. The biomarkers, or gene alterations, detected by the test enable oncologists to identify the targeted treatment strategies that are most effective for patients with advanced cancer.

The expanded number of biomarkers identified by the upgraded Guardant360 test includes all guideline-recommended genomic biomarkers across advanced solid tumors and emerging biomarkers that may impact treatment planning in the future. The test runs on the Guardant Infinity smart liquid biopsy platform, which uses a novel genomic and epigenomic sequencing technology that provides exceptional sensitivity and accurately quantifies disease burden tumor fraction at 10 times lower levels than the previous version of Guardant360. Results are provided in 7 to 10 days.

“Guardant360 is the leading liquid biopsy test for patients with advanced cancer, and this major upgrade through our Guardant Infinity smart liquid biopsy platform enables us to give oncologists a much more complete view of cancer,” said Helmy Eltoukhy, Guardant Health chairman and co-CEO. “Our updated test provides much broader gene panel coverage and analyzes both currently actionable and emerging biomarkers not available on any other liquid biopsy test. This upgrade will mark the beginning of a new chapter of tumor profiling that will be as profound as the original introduction of comprehensive profiling, informing cancer care teams about the optimal treatment strategy for their patients by giving them many more precision treatment options that can help improve their outcomes.”

The updated Guardant360 test is covered for Medicare fee-for-service patients with advanced solid tumor cancers as a standalone service, based on coverage conveyed by Palmetto GBA, a Medicare administrative contractor for the Molecular Diagnostics Services program (MolDX®), under the existing local coverage determination. The test is also covered by all major insurers, representing over 300 million covered lives.

Guardant360 tests have been used by more than 15,000 oncologists and are widely accepted for blood-based comprehensive genomic profiling, with more than 500 peer-reviewed publications and over 500,000 tests performed to date.

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 news 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 news 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 news 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.

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 new gene coverage of the upgraded Guardant360 test by Guardant Health (GH)?

The upgraded Guardant360 test now covers 739 genes, which is 10 times more cancer biomarkers than the previous version evaluated.

How has the sensitivity of the Guardant360 test (GH) improved with the upgrade?

The upgraded Guardant360 test now quantifies disease burden tumor fraction at 10 times lower levels than the previous version, providing exceptional sensitivity.

Is the upgraded Guardant360 test (GH) covered by insurance?

Yes, the upgraded Guardant360 test is covered by Medicare for fee-for-service patients with advanced solid tumor cancers and by all major insurers, representing over 300 million covered lives.

What is the turnaround time for results from the upgraded Guardant360 test (GH)?

Results from the upgraded Guardant360 test are provided in 7 to 10 days.

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