Guardant Health introduces new Guardant360 TissueNext test with nearly 500 biomarkers to identify more treatment options for patients with advanced cancer
Guardant Health has launched an upgraded version of its Guardant360 TissueNext test, which now identifies 498 genes or cancer biomarkers. This expanded gene panel helps oncologists find more targeted therapies for patients with advanced cancer. Additionally, operational improvements have streamlined the workflow, reducing the time to results to less than two weeks. The test is covered by Medicare for patients with advanced solid tumors. Guardant Health aims to improve patient outcomes by providing more comprehensive gene coverage. This new test can be ordered either alone or in combination with Guardant360 CDx to support guideline-recommended genomic profiling for advanced breast and lung cancer.
- The Guardant360 TissueNext test now identifies 498 cancer biomarkers, up from fewer genes previously.
- The test offers a faster turnaround time, with results provided in less than two weeks.
- Medicare covers the test for advanced solid tumor patients, enhancing accessibility.
- The expanded gene panel can help oncologists make better-informed treatment decisions for advanced cancer patients.
- The test can be ordered in combination with Guardant360 CDx, supporting comprehensive genomic profiling.
- No specific financial data or revenue projections were provided in the press release.
- Potential risks include the possibility that the expanded test might not significantly impact patient outcomes or market adoption.
Insights
The introduction of the Guardant360 TissueNext test, now covering nearly 500 biomarkers, marks a significant advancement in the field of personalized cancer treatment. By increasing the number of genes identified, this test can pinpoint more targeted therapies, potentially improving outcomes for patients with advanced cancers. This is particularly meaningful in oncology where treatment decisions are increasingly driven by specific genetic alterations in tumors.
Furthermore, the test's streamlined workflow and faster turnaround time can expedite treatment decisions, reducing the emotional and physical toll on patients awaiting their results. Coverage by Medicare underlines the test's clinical value and ensures that it can be broadly utilized, bypassing financial barriers for many patients. This is a pivotal step in making precision oncology more accessible.
The launch of the updated Guardant360 TissueNext test is likely to have a positive impact on Guardant Health's financial performance. The expanded gene panel and operational improvements could potentially increase the demand for this test, given the heightened capability to identify effective treatments for a broader range of cancers. This could translate into higher sales volumes and revenue growth.
Additionally, the test's Medicare coverage for comprehensive genomic profiling is a critical factor. Medicare reimbursement can drive significant revenue, as it often influences other insurers to follow suit. This coverage ensures a steady stream of patients, providing a stable revenue base. Guardant Health's strategy to blend its tissue and liquid biopsy tests also diversifies its product portfolio, potentially opening up new markets and customer segments.
The Guardant360 TissueNext test represents a substantial leap forward in the world of genomic profiling. By incorporating 498 biomarkers, it vastly improves the scope of actionable data available to oncologists. This level of comprehensive genomic profiling is important in personalizing treatment plans and could lead to better patient outcomes across various types of advanced solid tumors.
Another significant aspect is the reduced turnaround time. The ability to deliver results in less than two weeks can be pivotal in clinical decision-making, especially for patients with aggressive cancers where time is of the essence. Additionally, the test's coverage under Medicare enhances its accessibility and encourages wider adoption in clinical practice.
From an innovation standpoint, this development places Guardant Health at the forefront of precision oncology, reinforcing its position as a leader in the genomic testing market.
- Upgraded gene panel on tissue genomic profiling test covers 498 biomarkers, including guideline-recommended genes
- Operational improvements streamline workflow and shorten time to results
- Upgraded test covered by Medicare for comprehensive genomic profiling of all advanced solid tumors
The new Guardant360 TissueNext test will be 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 launch of the new Guardant360 TissueNext test is another step forward in our mission to conquer cancer with data,” said Helmy Eltouky, Guardant Health chairman and co-CEO. “In addition to identifying guideline-recommended biomarkers, the upgraded test now provides more comprehensive gene coverage, so oncologists can make better informed decisions about the optimal treatment strategy for their patients with advanced cancer and help improve their outcomes.”
Guardant360 TissueNext identifies clinically relevant actionable biomarkers in tumor tissue to help oncologists select patients with advanced cancer who may benefit from biomarker-informed treatment. Results are provided in less than two weeks.
The test, which first received Medicare coverage in March 2022, is part of Guardant’s comprehensive portfolio of blood- and tissue-based genomic profiling tests, including Guardant360 CDx, the first liquid biopsy test approved by the FDA for comprehensive genomic profiling of all solid tumors. The Guardant360 TissueNext test can be ordered alone or in combination with Guardant360 CDx to support guideline-recommended complementary liquid and tissue genomic profiling testing for advanced breast and lung cancer.
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 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 helping doctors select the best treatment 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.
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Investor Contact:
Zarak Khurshid
investors@guardanthealth.com
Media Contact:
Michael Weist
press@guardanthealth.com
+1 317-371-0035
Source: Guardant Health, Inc.
FAQ
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