Guardant Health’s FDA-approved Shield™ Blood Test Now Commercially Available in U.S. as a Primary Screening Option for Colorectal Cancer

Rhea-AI Summary

Guardant Health (Nasdaq: GH) has announced the commercial availability of its FDA-approved Shield™ blood test in the U.S. as a primary screening option for colorectal cancer (CRC). The test is now covered by Medicare for eligible beneficiaries once every three years. Shield is the first FDA-approved blood test for primary CRC screening, offering a convenient alternative to traditional methods.

Key points:

• 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia
• >90% patient adherence rate
• Outperforms stool-based tests in life years gained and CRC cases averted
• Results available in about two weeks

The launch represents a significant opportunity for Guardant Health and a major step in the fight against colorectal cancer.

Positive

• First FDA-approved blood test for primary colorectal cancer screening
• Medicare coverage for over 45 million beneficiaries
• 83% sensitivity for CRC detection with 90% specificity for advanced neoplasia
• >90% patient adherence rate, significantly higher than traditional methods
• Outperforms guideline-recommended stool-based tests in health outcomes
• Potential for expanded commercial insurance coverage pending guideline inclusion

Negative

• None.

Medical Research Analyst

The commercial launch of Guardant Health's FDA-approved Shield™ blood test for colorectal cancer (CRC) screening is a significant development in the field of oncology diagnostics. This test offers several advantages over traditional screening methods:

• It's the first FDA-approved blood test for primary CRC screening, providing a less invasive alternative to colonoscopy.
• Medicare coverage makes it accessible to over 45 million beneficiaries, potentially increasing screening rates.
• The test showed 83% sensitivity for CRC detection and 90% specificity for advanced neoplasia in the ECLIPSE study, comparable to current guideline-recommended methods.
• Patient adherence to the Shield test was over 90%, significantly higher than the 28-71% adherence rates for colonoscopy and stool-based testing.

The health outcome model suggests that Shield could outperform stool-based tests in terms of life years gained and CRC cases averted. However, it's important to note that while promising, the test still needs to be included in clinical guidelines to support private payer coverage, which could limit its immediate impact on the broader market.

Financial Analyst

The commercial launch of the Shield™ blood test represents a significant market opportunity for Guardant Health (Nasdaq: GH). Key financial implications include:

• Immediate Medicare coverage opens up a substantial market of over 45 million beneficiaries, providing a clear path to revenue generation.
• The test is covered once every three years, creating a recurring revenue stream.
• High patient adherence rates (90%) compared to traditional methods suggest strong potential for market penetration and sustained usage.
• Future inclusion in clinical guidelines could expand coverage to private insurers, significantly broadening the addressable market.

However, investors should consider that the full revenue potential may take time to realize as adoption rates grow and private insurance coverage expands. The company will likely need to invest in marketing and education to drive adoption among healthcare providers and patients. While the news is positive for Guardant Health's growth prospects, the impact on near-term financials may be gradual rather than immediate.

Market Research Analyst

The introduction of Guardant Health's Shield™ blood test could significantly disrupt the CRC screening market:

• The convenience factor of a simple blood draw could drive higher screening rates, potentially expanding the overall market size.
• A Kaiser Permanente study showed 3 times more people were screened when Shield was offered alongside traditional options, indicating strong consumer preference.
• The test's performance, combined with high adherence rates, positions it as a strong competitor to existing stool-based tests and colonoscopies.
• The 90% adherence rate suggests potential for market share gains from less convenient screening methods.

However, market adoption may face challenges:

• Established screening methods have entrenched positions in clinical practice.
• Physician education and changing established protocols will take time.
• Full market potential depends on inclusion in clinical guidelines and private insurance coverage.

The blood test's ease of use and potential to increase screening rates align with broader healthcare trends towards patient-centric, preventive care. This could accelerate adoption once initial barriers are overcome, potentially reshaping the CRC screening landscape in the coming years.

• FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening of colorectal cancer and meets coverage requirements for Medicare reimbursement
• Commercial launch of Shield and CMS coverage make blood-based screening option more accessible to millions of individuals at average risk for the disease

PALO ALTO, Calif.--(BUSINESS WIRE)-- Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that its Shield^™ blood test, recently approved by the U.S. Food and Drug Administration (FDA), is now covered by Medicare and is commercially available in the U.S. as the first FDA-approved blood test for primary colorectal cancer (CRC) screening.

The Centers for Medicare & Medicaid Services (CMS) now covers the Shield test based on the criteria established in its National Coverage Determination for blood-based colorectal cancer screening tests (NCD 210.3). The test is covered once every three years for eligible Medicare beneficiaries.

“The commercial launch of the Shield test and Medicare coverage make it possible for millions of eligible individuals to access a convenient, more pleasant way to stay up to date with colorectal cancer screening and detect the disease early, when it is more easily treated,” said AmirAli Talasaz, Guardant Health co-CEO. “From day one, Shield will be covered for more than 45 million Medicare beneficiaries, including many who are non-compliant with colonoscopy. This represents both a major step forward in the fight against colorectal cancer and a significant opportunity for Guardant Health. We also look forward to the process of getting Shield included in clinical guidelines to support private payer coverage, which will enable even broader and more equitable access.”

Commercial insurance coverage for patients eligible for CRC screening will continue to expand pending future review and inclusion in guidelines by the American Cancer Society and the U.S. Preventive Services Task Force (USPSTF).

The Shield test received FDA approval as a primary non-invasive option for CRC screening in average-risk adults age 45 and older. The FDA approval was based on results of ECLIPSE, a 20,000+-patient registrational study evaluating the performance of the test for detecting CRC in average-risk adults. Results from the study, published in The New England Journal of Medicine, showed that Shield demonstrated 83% sensitivity for the detection of CRC, with 90% specificity for advanced neoplasia. This performance is within range of current guideline-recommended non-invasive screening methods, in which overall CRC sensitivity ranges from 74% to 92%.^1,2

Screening for CRC is only effective if the test is completed. Over the last two years, among more than 20,000 Shield tests ordered by providers, there was greater than 90% adherence by patients to their provider’s order for CRC screening, a much higher rate than the 28-71% adherence to colonoscopy and stool-based testing.^2,3 Further, a randomized study from Kaiser Permanente demonstrated that when Shield blood testing was offered as an additional choice to standard screening options of stool testing and colonoscopy, 3 times more people were screened.⁴

In addition, a health outcome model (CAN-SCREEN) evaluating 1000 individuals age 45 - 75 years and at average risk of colorectal cancer demonstrates how combining test performance and high patient adherence through blood-based screening can optimize CRC-related health outcomes. Shield outperforms two guideline-recommended stool-based tests, fecal immunochemical test (FIT) and the multi-target stool DNA (mtsDNA) test when considering life years gained (214 vs. 157 and 199) and CRC cases averted (27 vs. 16 and 22). Shield also prevents more deaths from CRC (13 vs. 7 and 11).⁵

“The idea of introducing a blood test that can screen for colorectal cancer has been a dream of mine for decades,” said Andrew Spiegel, Chief Executive Officer of the Global Colon Cancer Association. “And that’s because I’ve seen the toll that colorectal cancer takes on the lives of those it impacts – especially when caught late. Having a test now in our toolbox that is so simple and straightforward to do will hopefully eliminate any and all excuses for skipping screening and help us finally bring our country’s screening rates to where they need to be.”

Healthcare providers can have patients complete a Shield test with a simple blood draw during a routine office visit, with test results available approximately two weeks after the sample is received at the Guardant Health lab. For complete product information about the Shield blood test for CRC screening, including full safety information, visit ShieldCancerScreen.com.

About Shield

Shield is a non-invasive, blood-based screening test that detects alterations associated with colorectal cancer in the blood. It is intended as a screening test for individuals at average risk for the disease, age 45 or older, and is not intended for individuals at high risk for colorectal cancer. The Shield test can be considered in a manner similar to guideline-recommended non-invasive CRC screening options and can be completed during any healthcare visit. A positive Shield result raises concern for the presence of colorectal cancer or advanced adenoma and the patient should be referred for colonoscopy evaluation.

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 and accelerating new cancer therapies 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 treatment selection 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 press 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 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, 2023, and any current and periodic reports filed with or furnished to the Securities and Exchange Commission thereafter. 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. Chung DC, Gray DM, Singh H et al. A Cell-free DNA Blood-Based Test for Colorectal Cancer Screening. N Engl J Med. Mar 2024.
2. Guardant Health MCGP May 23, 2024. Sponsor Executive Summary available at fda.gov
3. Raymond et al. Am J Gastro. Oct 2023.
4. Coronado, et al. Gut. Jan 2024.
5. Forbes et al. Journal of Medical Economics. 2024.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240801316789/en/

Investor Contact:

Zarak Khurshid

investors@guardanthealth.com

Media Contact:

Mike Weist

press@guardanthealth.com

+1 317-371-0035

Source: Guardant Health, Inc.

FAQ

What is the Shield™ blood test by Guardant Health (GH) used for?

The Shield™ blood test is FDA-approved for primary screening of colorectal cancer in average-risk adults aged 45 and older.

Is the Guardant Health (GH) Shield™ test covered by Medicare?

Yes, the Shield™ test is covered by Medicare once every three years for eligible beneficiaries, based on CMS National Coverage Determination criteria.

What is the sensitivity and specificity of the Guardant Health (GH) Shield™ test?

The Shield™ test demonstrated 83% sensitivity for detecting colorectal cancer and 90% specificity for advanced neoplasia in the ECLIPSE study.

How does the Guardant Health (GH) Shield™ test compare to other screening methods?

Shield™ outperforms guideline-recommended stool-based tests in life years gained, CRC cases averted, and CRC deaths prevented, according to a health outcome model.

When will the Guardant Health (GH) Shield™ test be available for commercial insurance coverage?

Commercial insurance coverage is expected to expand pending review and inclusion in guidelines by the American Cancer Society and the U.S. Preventive Services Task Force.