REDWOOD CITY, Calif., March 19, 2018 /PRNewswire/ -- Guardant Health applauds Medicare for changes it made to a final National Coverage Decision (NCD) that ensure continued access to molecular diagnostics for Medicare beneficiaries with advanced cancer.
The Centers for Medicare and Medicaid Services (CMS) published a final NCD March 16 that outlined a path to coverage for next-generation sequencing (NGS) tests for patients with advanced cancer, regardless of the sample type – tissue or blood.
"This decision benefits patients because it preserves existing access to liquid biopsies for Medicare beneficiaries while creating a clear path for expanded coverage in connection with FDA approval or clearance of companion in vitro diagnostic tests," said Guardant Health Co-founder and CEO Helmy Eltoukhy. "Additionally, we are grateful CMS updated its initial draft to reflect the evidence supporting the use of NGS-based liquid biopsies like the Guardant360® assay."
The decision describes two clear pathways for reimbursement for NGS-based liquid biopsies. The first is through local Medicare Administrative Contractors, where the Guardant360 assay has a draft local coverage decision in advanced lung cancer pending. The second is for multiple cancer types through the NCD in conjunction with an FDA-approved or FDA-cleared companion in vitro diagnostic test.
"Treatment planning in advanced lung cancer is most successful when doctors and patients can access genomic information about each patient's tumor," said Andrea Ferris, CEO of LUNGevity Foundation, an organization dedicated to improving outcomes in lung cancer and patient access to the appropriate treatments. "This decision will help ensure every Medicare patient with advanced lung cancer can access optimal therapy, regardless of the amount of tumor tissue acquired in their initial biopsy."
About Guardant HealthGuardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading investors. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available and available in more than 30 countries. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc. Learn more at www.guardanthealth.com.
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The Centers for Medicare and Medicaid Services (CMS) published a final NCD March 16 that outlined a path to coverage for next-generation sequencing (NGS) tests for patients with advanced cancer, regardless of the sample type – tissue or blood.
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"This decision benefits patients because it preserves existing access to liquid biopsies for Medicare beneficiaries while creating a clear path for expanded coverage in connection with FDA approval or clearance of companion in vitro diagnostic tests," said Guardant Health Co-founder and CEO Helmy Eltoukhy. "Additionally, we are grateful CMS updated its initial draft to reflect the evidence supporting the use of NGS-based liquid biopsies like the Guardant360® assay."
The decision describes two clear pathways for reimbursement for NGS-based liquid biopsies. The first is through local Medicare Administrative Contractors, where the Guardant360 assay has a draft local coverage decision in advanced lung cancer pending. The second is for multiple cancer types through the NCD in conjunction with an FDA-approved or FDA-cleared companion in vitro diagnostic test.
"Treatment planning in advanced lung cancer is most successful when doctors and patients can access genomic information about each patient's tumor," said Andrea Ferris, CEO of LUNGevity Foundation, an organization dedicated to improving outcomes in lung cancer and patient access to the appropriate treatments. "This decision will help ensure every Medicare patient with advanced lung cancer can access optimal therapy, regardless of the amount of tumor tissue acquired in their initial biopsy."
About Guardant HealthGuardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. Using both molecular and digital tools, Guardant Health is addressing challenges across the cancer care continuum. The company has raised more than $500 million from leading investors. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available and available in more than 30 countries. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc. Learn more at www.guardanthealth.com.
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SOURCE Guardant Health
