Guardant Health Receives ADLT Status from CMS for FDA-Approved Guardant360® CDx Test

Rhea-AI Summary

Guardant Health (Nasdaq: GH) has received Advanced Diagnostic Laboratory Test (ADLT) status approval from CMS for its Guardant360 CDx test, the first FDA-approved liquid biopsy for tumor mutation profiling across all solid cancers. This ADLT status indicates that the test meets criteria for innovative products. Effective from January 1, 2022, Medicare will reimburse the test at $5,000 during a nine-month data collection period. This milestone is expected to facilitate broader payer coverage and enhance patient access to comprehensive genomic profiling, improving treatment options for advanced cancer patients.

Positive

• CMS approval of ADLT status for Guardant360 CDx test enhances market position.
• Reimbursement rate of $5,000 for Medicare patients increases adoption potential.
• Broadening payer coverage expected to improve access for advanced cancer patients.

Negative

• None.

Guardant Health, Inc. (Nasdaq: GH) announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT) status for the Guardant360^® CDx test. The Guardant360 CDx test is the first FDA-approved liquid biopsy for comprehensive tumor mutation profiling across all solid cancers.

Under the Protecting Access to Medicare Act of 2014 (PAMA), CMS determination confirms that the Guardant360 CDx test meets the criteria for ADLT status, which is reserved for innovative products that provide novel clinical information that cannot be obtained by any other method, and for FDA-approved tests. Obtaining ADLT status initiates a specific, market-based approach to pricing the test for Medicare patients. During the nine-month period beginning April 1, 2021 and ending December 31, 2021, Guardant Health will collect, assess and submit private-payer payment rate data for the test, the median of which will be used by CMS to determine the Medicare pricing, beginning January 1, 2022. During this nine-month period, the Guardant360 CDx test will be reimbursed at a rate of $5,000 for all Medicare patients.

“Obtaining ADLT status for our Guardant360 CDx test is an important milestone that not only demonstrates the value that our FDA-approved liquid biopsy test brings to patients with advanced cancer, but also paves the way for broader payer coverage,” said Helmy Eltoukhy, Guardant Health CEO. “We believe this milestone is a critical step to ensuring that all patients have access to our Guardant360 CDx test, so that their treatment is informed by comprehensive genomic profiling in-line with today’s medical guidelines.”

Each year, more than 600,000 people die from cancer in the United States,¹ many of whom may have benefitted from comprehensive genomic profiling (CGP) to guide a more personalized treatment plan based on a growing list of effective CGP-informed targeted therapies. Clinical studies show that patients receiving targeted therapies have improved progression-free survival and higher overall response rates relative to chemotherapy or immunotherapy.^2-8 Guardant360 CDx offers patients and clinicians a simple, faster blood test to help inform personalized treatment options.

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. The Guardant Health oncology platform leverages capabilities to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs across all stages of the cancer care continuum. Guardant Health has commercially launched liquid biopsy-based Guardant360^®, Guardant360 CDx, and GuardantOMNI^® tests for advanced stage cancer patients, and Guardant Reveal^™ test for early-stage cancer patients. These tests fuel development of its LUNAR screening program, which aims to address the needs of asymptomatic individuals eligible for cancer screening and individuals at a higher risk for developing cancer with early detection.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of federal securities laws, including statements regarding the potential scope, impact or benefit of Guardant Health liquid biopsies 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 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, 2020 as well as in its other reports filed with the Securities and Exchange Commission, including, when filed, its Quarterly Report on Form 10-Q for the period ended March 31, 2021. 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.

REFERENCES

1. Centers for Disease Control and Prevention. Available at: https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm. Accessed March 29, 2021.
2. Shaw AT, Riely GJ, Bang Y-J, et al. Crizotinib in ROS1-rearranged advanced non-small-cell lung cancer (NSCLC): updated results, including overall survival, from PROFILE 1001. Ann Oncol. 2019;30(7):1121-1126.
3. Ramalingam SS, Gray JE, Ohe Y, et al. Osimertinib vs comparator EGFR-TKI as first-line treatment for EGFRm advanced NSCLC (FLAURA): Final overall survival analysis. Ann Oncol. 2019;30(5): v851-v934.
4. Garon EB, Hellmann MD, Costa EC, et al. Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001. J Clin Oncol. 2019;37(28):2518-2527.
5. Camidge DR, Dziadziuszko R, Peters S, et al. Updated Efficacy and Safety Data and Impact of the EML4-ALK Fusion Variant on the Efficacy of Alectinib in Untreated ALK-Positive Advanced Non–Small Cell Lung Cancer in the Global Phase III ALEX Study. J Thorac Oncol. 2019;14(7):1233-1243.
6. https://www.hcp.novartis.com/products/tafinlar-mekinist/metastatic-nsclc/efficacy/. Accessed August 1, 2020.
7. Gadgeel SM, Garassino MC, Esteban E, et al. KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC. J Clin Oncol. 2019;37(suppl; abstr 9013).
8. Sandler A, Gray R, Perry MC, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006;14;355(24):2542-2550.

 

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FAQ

What is Guardant Health's recent announcement regarding the GH stock?

Guardant Health announced that CMS approved ADLT status for its Guardant360 CDx test, improving market viability.

What does ADLT status mean for Guardant Health's Guardant360 CDx test?

ADLT status means the test is recognized as innovative and eligible for a Medicare pricing model.

What is the reimbursement rate for the Guardant360 CDx test under Medicare?

The Guardant360 CDx test will be reimbursed at a rate of $5,000 for Medicare patients.

When will Guardant Health start receiving Medicare reimbursements for the Guardant360 CDx test?

Medicare reimbursements will begin on January 1, 2022.