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Guardant Health

Guardant Health is a leading precision oncology company dedicated to helping conquer cancer globally through use of our proprietary blood tests, vast data sets, and advanced analytics. At Guardant Health, we believe liquid biopsy is at the center of transforming cancer care by unlocking data that will help patients at all stages of the disease. While we’ve made great strides to help advanced cancer patients, our vision since inception has been to detect cancer early, when patient survival rates can be impacted most. We are committed to helping patients across the cancer care continuum live longer, healthier lives.

Lobbying Activity

Response to Cancer Screening Recommendation

18 Feb 2022

Guardant Health encourages the Commission to consider how new and imminently available screening modalities, such as blood-based tests, can be incorporated into cancer screening recommendations and programs to improve health outcomes across the EU. Guardant Health is a leading precision oncology company focused on helping conquer cancer globally and is a pioneer in non-invasive cancer diagnostics. In March, Guardant Health will launch Guardant Shield™, the company’s first blood-based screening test to detect colorectal cancer (CRC) and plans to seek regulatory approval in the U.S. in 2022. This regulatory submission will be supported by the ECLIPSE clinical trial, which is a prospective, multi-site registrational study to evaluate the performance of Guardant Heath’s blood-based test to detect CRC in average risk adults. ECLIPSE has reached its target enrollment of 12,750 patients. The results of this study will be available later this year. One of the Council’s stated objectives for the revision is to increase screening rate for cancers currently covered by the Council Recommendation, including CRC cancer. A blood-based screening option can improve CRC screening rates by overcoming barriers associated with current methods. Examples of such barriers include a lack of available medical facilities, transportation challenges, and time. A simple blood draw can conveniently occur in a doctor’s office or in alternate settings by a trained phlebotomist, which can improve completion rates over stool-based tests that require patients to later return the sample. Incorporating available blood-based testing options into CRC screening programs has the potential to dramatically increase screening rates, especially in underserved populations. To add value to existing screening programs and be applicable in clinical care, any blood-based cancer screening tests must have high performance in detecting early-stage cancer on par with other non-invasive screening methods. Although many multi-cancer screening tests are being explored, some may have lower sensitivity in detecting early stage cancers. It is critical that tests do not reduce participation in existing screening paradigms which work. Patients tend to avoid duplication, so it is important to focus on high-performing tests where there is proven impact on outcomes. At Guardant Health, we are targeting cancers where we know early intervention reduces mortality so that we can be confident our tests will save lives - CRC is our first indication; our next indication will be lung cancer. In these cancers, there are established clinical pathways that a patient can follow if they receive a positive result, and a blood-based test could significantly increase access to screening and improve early diagnosis. Lung cancer is the leading cause of cancer mortality worldwide, accounting for one in five cancer deaths. Early detection can have a significant impact on survival, as a large proportion of patients present with late-stage disease, when treatment is less successful. Several randomized controlled trials (RCTs) of lung cancer screening now show a statistically significant reduction in lung cancer mortality in participants. For example, the NELSON trial found that LDCT screening is highly effective and can significantly reduce lung cancer deaths in high-risk individuals. Guardant Health is now launching a prospective, registrational study to evaluate the accuracy of our blood test to detect lung cancer in high-risk adults. The screening for high-frequency malignant disease (SHIELD) study plans to examine 10,000 patients across 100 centres in the United States and Europe and enrolled its first patient in January 2022. In establishing any screening programs, we urge the Commission to consider how the incorporation of high performing blood-based tests, supported by appropriate evidence, can reach patients as quickly as possible.
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