Guardant Health applauds proposed FY2024 budget increases and pledges support for the Biden-Harris Administration Moonshot goal to end cancer as we know it

PALO ALTO, Calif., March 10, 2023 – Guardant Health, Inc., alongside partners from across the advocacy community, industry and public sector, today participated in the White House’s Colorectal Cancer Forum to discuss concrete ways to advance the Biden-Harris Administration’s Cancer Moonshot goals. Reducing the death rate from cancer by at least 50 percent over the next 25 years and improving the experience of people and families living with and surviving cancer is a hallmark of Guardant Health’s patient-first philosophy. 

In the proposed FY2024 budget, released yesterday, President Biden took a meaningful step towards accelerating access to innovative cancer screenings. Specifically, he increased funding for the Agency for Healthcare Research and Quality (AHRQ), which is the agency that supports the United States Preventive Services Task Force. This action is a cornerstone of Guardant Health’s shared commitment to achieving the goals of the Cancer Moonshot, and we applaud the President’s proposed increase from $12 to $18 million to support the USPSTF. This will empower the Task Force to increase the number of reviews, implement finalized recommendations, and enable the modernization of current processes with the goal of improving preventive care for Americans. 

Showcasing his commitment, the budget includes $1.7 billion for dedicated Cancer Moonshot activities across the Department of Health and Human Services (HHS), in addition to targeted investments at the Departments of Veterans Affairs, Defense, Agriculture, and other Cancer Cabinet agencies, and a total investment of $7.8 billion at the National Cancer Institute (NCI) to drive progress on ways to prevent, detect, and treat cancer. The budget also provides an increase of $1 billion for the Advanced Research Projects Agency for Health (ARPA-H), for a total of $2.5 billion, to drive innovative health research and speed the implementation of breakthroughs that would transform the treatment, prevention, and early detection of cancer and other diseases.

Achieving the Administration’s goals to end cancer as we know it takes broad public and private industry collaboration, and Guardant Health remains committed to bringing life-saving blood-based technologies to patients and bending the cancer mortality curve through: 

1. Increase screening compliance for all eligible individuals, including minority, rural and underserved populations, through research partnerships: At Guardant Health, we believe the best test to screen for colorectal cancer is the one that gets done. We also believe that accurate, less-invasive blood tests can help patients overcome access barriers to current colorectal cancer (CRC) screening modalities and help us collectively achieve our objective of getting every eligible individual screened, especially in rural, minority and underserved populations.

Only 40% of eligible patients at Federally Qualified Health Centers (FQHCs) were screened for CRC in 2020, which is almost 30% lower than the national average.1,2 To address access barriers for this traditionally underserved population, Guardant Health recently launched a study in partnership with the University of Chicago that focuses on implementing blood-based CRC screening in FQHCs across diverse communities in Illinois and Indiana. An additional study led by The Ohio State University Comprehensive Cancer Center will send mobile health clinics into rural communities across Appalachia to study uptake of a blood-based CRC screening option in an area where cancer mortality is 10% higher than the national average.3

Screening rates for lung cancer are historically even lower, with only 14% of the eligible population being up to date with recommended screening.4 As a result, Guardant Health is partnering with the U.S. Veterans Affairs (VA) based in Durham, North Carolina to help reach over 12 million different patients who might be eligible for lung cancer screening as part of our SHIELD LUNG trial, an evaluation study for our blood-based lung cancer screening test. 

2. Prioritize diversity in clinical trials: Most clinical trials in the U.S. enroll a patient population that is not reflective of our nation’s diversity.5 For example, in more than 100 clinical trials for preventive measures and treatments, women, Asian, and Black participants were underrepresented.6 Yet, many of the diseases studied in these trials disproportionately impact minorities making it absolutely crucial that clinical trials reflect the diverse populations who will benefit from the treatment or medical device being evaluated. When enrolling for our ECLIPSE study, we made it a priority to enroll a population and design our study to reflect our country’s diverse population, and we successfully enrolled over 20,000 individuals from 34 states between the ages of 45-84, and achieved 13% enrollment among Black Americans, 15% among Hispanics and 7% among Asian Americans. Data from our pivotal ECLIPSE study is used to support our pre-market approval (PMA) submission to the U.S. Food and Drug Administration for our Shield™ blood test. 

Achieving diversity in clinical studies is crucial to improving overall health equity, which has rightly been a priority of the Biden Administration and this Congress. Yet doing so also requires a responsibility by study sponsors to invest in strategies that prioritize diverse enrollment in all clinical trials, and Guardant Health remains committed to doing so. 

3. Modernize the U.S. Preventive Services Task Force: Achieving the goals established by the Biden-Harris Administration depends on the ability to ensure widespread clinical adoption of medical breakthroughs like blood-based testing. We believe the Biden Administration and this Congress have a role to play in supporting patient access to innovative screening technologies through the modernization of the U.S. Preventive Services Task Force (USPSTF), and we applaud the work that has already been done by Members of Congress to prioritize these efforts.

Following submission of our PMA application to the U.S. FDA, Guardant Health is on track to become the first company to develop an FDA approved blood-based screening test for CRC which will pave the way for Medicare coverage if approved. However, without continued support from the Biden Administration and action by this Congress, access to approved screening tests for eligible patients will be delayed due to the timing of USPSTF’s current review cycles.

Prioritizing review of new screening tests or preventive medications that are approved or cleared by the FDA is critical for patients. The USPSTF should be given the flexibility to utilize its “Early Topic Update” process to review a recommendation on an enhanced timeframe upon a showing of new evidence. Access to emerging and innovative medical technologies, like blood-based cancer screening tests, can address health inequities for all Americans, and we should not ask them to accept any avoidable delays. 

For more information on how Guardant Health is advocating for access to modern cancer screenings, visit https://guardanthealth.com/about/democratize-cancer-screening/. 

About Guardant HealthGuardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary 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 Guardant360®, Guardant360® CDx, Guardant360 TissueNext™, Guardant360 Response™, and GuardantINFINITY™ tests for advanced-stage cancer patients, and Guardant Reveal™ for early-stage cancer patients. The Guardant Health screening portfolio, including the Shield™ test, aims to address the needs of individuals eligible for cancer screening. For more information, visit guardanthealth.com and follow the company on LinkedIn and Twitter.

References 

  1. National Colorectal Cancer Round Table. CRC News: August 12, 2021. https://nccrt.org/crc-news-august-12-2021/#:~:text=2020%20UDS%20Data%20on%20CRC%20Screening%20in%20FQHCs%20Now%20Available&text=HRSA%20reported%20an%20overall%20colorectal,a%20UDS%20measure%20in%202012. Accessed online March 10, 2023.
  2. American Cancer Society. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/colorectal-cancer-facts-and-figures/colorectal-cancer-facts-and-figures-2020-2022.pdf. Accessed online March 10, 2023.
  3. Association of Community Cancer Centers. Creating a Culture of Health in Appalachia. https://www.arc.gov/wp-content/uploads/2021/02/Health_Disparities_in_Appalachia_Mortality_Domain.pdf. Accessed online February 17, 2023.
  4. Zahnd WE, Eberth JM. Lung cancer screening utilization: a behavioral risk factor surveillance system analysis. Am J Prev Med. 2019;57(2):250-255. doi:10.1016/j.amepre.2019.03.015
  5. U.S. Food & Drug Administration. 2020 Drug Trials Snapshots Summary Report. FDA.gov website. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-trials-snapshots. Accessed December 1, 2022.
  6. Armstrong, Annalee. December 6, 2022. Women, Asian and Black participants underrepresented in COVID-19 clinical trials, researchers find. Fierce Healthcare. https://www.fiercebiotech.com/biotech/women-asian-and-black-participants-underrepresented-covid-19-clinical-trials-researchers 

Guardant Health Contacts 

Media Contact:

Breen Weir
press@guardanthealth.com
+1 843-384-0095