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Palmetto GBA issues Draft Local Coverage Determination Expanding Guardant360 Medicare Coverage to Most Solid Tumor Types

1150 Days ago

REDWOOD CITY, Calif., March 28, 2019 (GLOBE NEWSWIRE) -- Guardant Health, Inc. (Nasdaq: GH), announced that Palmetto GBA, a Medicare Administrative Contractor, has posted a draft local coverage determination (LCD) expanding Medicare coverage of the Guardant360® assay from advanced non-small cell lung cancer (NSCLC) to over a dozen advanced solid tumor cancer types with guideline-recommended genomic targets.

The draft LCD would apply to advanced cancer patients who are covered by Medicare for next-generation sequencing of tumor tissue, but have insufficient or unavailable tissue samples. These cases may comprise a significant percentage of advanced cancers, especially those that have spread to the deep viscera, bone, or brain.  

“This is an important step toward making sure all Medicare beneficiaries with advanced cancer have timely access to guideline-recommended treatment options,” said Guardant Health co-founder and CEO Helmy Eltoukhy, PhD.

Palmetto GBA is expected to finalize and implement the LCD after soliciting public comments. In July 2018, Palmetto GBA and other MACs finalized an LCD covering Guardant360 for patients with advanced NSCLC.

About Guardant Health
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics.  Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs.  In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.

Forward-looking Statements
This press release contains forward-looking statements within the meaning of federal securities laws. 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. 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, 2018 and in its other reports filed with the Securities and Exchange Commission. 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.

Investor Contact:
Lynn Lewis or Carrie Mendivil

Media Contact:
Josh Wein or Ian Stone

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