NOW FDA APPROVED FOR COLORECTAL CANCER (CRC) SCREENING

Innovative
cancer
screening

The Shield™ blood test uses Guardant Health’s groundbreaking technology to help inform timely interventions1

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Guardant Health is a pioneering diagnostics company with over a decade of experience2

More oncologists choose Guardant Health than any other blood test company3*

Our goal is to get patients the right diagnostic intervention, at the right time

See the NEJM publication >

*Internal data on file, March 2024

†Important Note: The Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 tests were developed, and their performance characteristics determined, by the Guardant Health Clinical Laboratory in Redwood City, CA, USA, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing. Guardant Reveal, Guardant360 TissueNext, Guardant360 Response, and Guardant360 are Laboratory Developed Tests (LDTs). These tests have not been cleared or approved by the US FDA. Guardant360 CDx is not approved by the US FDA to assess treatment response or long-term survival

‡Patient timeline shown for illustrative purposes only

§Internal data on file, May 2024

See how the people at Guardant Health are

working to give patients with cancer more time

Introduction

Time is everything. When someone learns that they have been diagnosed with advanced cancer, they are stunned. Struck with fear, grief, and hopelessness all at once. They don't know what to do next. They wonder how much time they have left. Oncologists stand at the front lines, waging this battle against cancer for their patients every single day. It's a race against the clock in a relentless fight with an aggressive, unforgiving disease. Oncologists need to move as fast as possible to guide their patients to optimal treatment and then assess whether their patient is responding or not.

Guardant360®

Guardant Health is dedicated to radically improving the way oncologists manage their patients’ cancer. In 2014, the company launched Guardant360®, the first liquid biopsy available for guideline-complete genomic profiling. This new blood-first approach supercharged oncologists’ ability to make the optimal treatment decisions faster than ever before. Instead of waiting weeks for tissue biopsy results, oncologists can start personalized treatment within days.

In 2020, Guardant360® CDX became the first FDA-approved liquid biopsy for comprehensive genomic profiling of all solid tumors, achieving the highest level of endorsement for widespread use. Today, Guardant Health is excited to introduce Guardant360 Response™, the industry's first blood-only test that enables oncologists to assess their patient’s response to immunotherapy or targeted therapy 6 to 8 weeks before their first scan. Guardant Health is also offering oncologists Guardant360 TissueNext™, for those instances when a blood test does not identify an actionable mutation. This blood-first, tissue-next approach streamlines biomarker testing, allowing all the efficiency from a single lab.

Guardant Reveal™

The Guardant360 portfolio delivers on the promise of precision oncology, giving oncologists the tools to monitor their patients’ progress at each and every step of the treatment journey.

But there's more. Guardant Health is helping early-stage cancer patients, too. Earlier this year, the company launched Guardant Reveal, the first blood-only test that is able to detect minimal residual disease after curative intent surgery and monitor recurrence in patients with colorectal cancer. Every day at Guardant Health, we are demonstrating that our tests hold the power to transform the trajectory of cancer. With each step along the patient's journey, Guardant Health is providing oncologists with the critical insights to help them take action and give their patients the best possible outcomes. And we aren't stopping there. Through every milestone, Guardant Health will continue to work tirelessly to help provide patients with the most precious thing there is in life: more time. More time to enjoy life with their loved ones. More time to make memories. More time for those special moments. More time when they need it most.

See Shield data

“It is the one test that is now bringing colon cancer screening into the 21st century”

—
Monnieque Singleton, MD
Family Medicine
Specialist

Important Product Information

Intended Use

The Shield™ test is a qualitative, in vitro diagnostic test intended to detect colorectal cancer derived alterations in cell-free DNA from blood collected in the Guardant Shield Blood Collection Kit.
Shield is indicated for colorectal cancer screening in individuals at average risk for the disease, age 45 years or older. Patients with a positive result should be followed by colonoscopy. Shield is not a replacement for diagnostic colonoscopy or for surveillance colonoscopy in high-risk individuals. This test is performed at Guardant Health, Inc.

Precaution: Based on data from clinical studies, Shield has limited detection (55%-65%) of Stage I colorectal cancer and does not detect 87% of precancerous lesions. One out of 10 patients with a negative Shield result may have a precancer that would have been detected by a screening colonoscopy. Shield demonstrated high detection of Stage II, III, and IV colorectal cancer.

Limitations and Other Important Information: The Shield test is not indicated for patients that have personal history of colorectal cancer, adenomas, or other related cancers; or those who had a positive result on another colorectal cancer screening method within the last six months, have been diagnosed with a condition associated with high risk for colorectal cancer such as Inflammatory Bowel Disease (IBD), chronic ulcerative colitis (CUC), Crohn’s disease; or who have a family history of colorectal cancer, or certain hereditary syndromes. Providers should discuss the most appropriate screening test to use with patients depending on their medical history and individual circumstances. Shield may produce a false negative or false positive result. A false negative result may occur when the Shield test does not detect a colorectal tumor signal while a colonoscopy identifies a colorectal cancer. A negative result does not guarantee the absence of colorectal cancer or advanced adenoma, and patients should continue participating in colorectal cancer screening programs at the appropriate guideline-recommended intervals. A false positive result may occur when the Shield test generates a positive result while a colonoscopy will not find colorectal cancer or advanced adenoma.

Please read our Provider Brochure for complete product information about the Shield test including full safety information.

  1. References:
  2. Chung DC, Gray DM II, Singh H, et al. A cell-free DNA blood-based test for colorectal cancer screening. N Engl J Med. 2024;390(11):973-983. doi:10.1056/NEJMoa2304714
  3. Guardant Health releases breakthrough blood test to improve cancer treatment. News release. PR Newswire. February 12, 2014. Accessed May 21, 2024. https://www.prnewswire.com/news-releases/guardant-health-releases-breakthrough-blood-test-to-improve-cancer-treatment-245258881.html
  4. Data on file. Guardant Health, Inc.
  5. Guardant Health surpasses 500 peer-reviewed publications milestone. March 7, 2024. Accessed May 23, 2024. https://investors.guardanthealth.com/press-releases/press-releases/2024/Guardant-Health-Surpasses-500-Peer-Reviewed-Publications-Milestone/default.aspx