Guardant Health Announces Draft Medicare Local Coverage Determination for the Guardant360 Assay

Thursday, May 18, 2017 General News
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REDWOOD CITY, Calif., May 18, 2017 /PRNewswire/ -- Guardant Health® announced that Palmetto GBA, a Medicare Administrative

Contractor and leader in evaluating molecular diagnostic technology through its laboratory technology assessment group, MolDx, has posted a draft local coverage determination (LCD) for the Guardant360® assay. Palmetto GBA and Noridian Healthcare
Solutions, the local MAC for California-based laboratories, are expected to finalize and implement the LCD after soliciting public comments.

"This is an important development to help ensure that Medicare patients with advanced lung cancer can access less toxic, effective targeted treatments. Often patients endure the safety risks and pain of invasive lung biopsies, at considerable cost to the healthcare system, without getting sufficient tissue for comprehensive genomic profiling," said Helmy Eltoukhy, co-founder and CEO of Guardant Health. "And for patients who are progressing on a treatment that's no longer effective, Guardant360 can provide critical molecular information for treatment decisions without the safety risk of an invasive biopsy."

Lung cancer guidelines increasingly call for broad molecular profiling because patients who are matched to drugs targeted to their tumor's specific mutation often have better outcomes than those treated with standard chemotherapy. Nonetheless, the difficulty in acquiring lung-tumor tissue often leads to incomplete testing. A recent study showed that fewer than half of newly diagnosed advanced lung cancer patients receive all recommended genomic testing1, while an analysis of Medicare claims data found that the average lung biopsy costs Medicare more than $14,000 because nearly one in five leads to adverse events2.

"All patients deserve to know if they are good candidates for treatment with less toxic, targeted drugs. They should not have to undergo repeat invasive biopsies when their initial biopsy produces insufficient tissue for comprehensive genomic testing, or when their initial treatment is failing and their cancer is progressing," said Bonnie Addario, chair of the Bonnie J. Addario Lung Cancer Foundation. "When adopted, this medical policy will help give Medicare beneficiaries with non-small cell lung cancer the opportunity to learn their best available treatment options."

About Guardant Health

Guardant 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 venture capital firms. Its first product, the Guardant360 assay, came to market in 2014, and is now the most widely ordered comprehensive liquid biopsy commercially available. Guardant Health and Guardant360 are registered trademarks of Guardant Health, Inc.

1. Gutierrez et al. 2017 Clinical Lung Cancer

2. Lokhandwala et al. 2016 Clinical Lung Cancer


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SOURCE Guardant Health

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