Multi-Cancer Early Detection (MCED) Tests
A New Approach in the War on Cancer
Cancer Screening in the General Population
Early detection and diagnosis of cancer have been proven to signiﬁcantly improve survival
rates and reduce the cost and complexity of treatment for cancers with recommended
screenings.1 In fact, the overall survival rate for cancer is four times higher when cancer isfound before it spreads.2
Today, cancer screening is recommended for ﬁve types of cancer—breast, cervical,colorectal, lung (smokers considered at risk) and prostate cancers. Unfortunately,
because there aren't single-cancer screenings available for most cancer types, many
cancers are detected too late, after they have spread. Treatment at this stage can be
more difﬁcult and costly.
Multi-cancer early detection (MCED) tests are blood-based tests that complement recommended
cancer screenings by detecting a cancer signal shared by a broad range of cancers.
These tests are a promising new tool in our arsenal in the war against cancer. Added to standard
care, a MCED test could reduce 5-year cancer-related mortality in detected cancers by 39% or
26% of all cancer related deaths (modeled data in an elevated risk population age 50-79).3

Cancer in the U.S.
Despite 50 years since waging the war on cancer, it remains the second leading cause of deathin the U.S. We need to transform the way we screen for cancers to detect them in earlier stages
than they most often are today. The earlier that cancer is detected, the higher the chance of
successful outcomes.
It is estimated that~40%of men and women
will develop cancer
during their lifetime.45-YEAR CANCER-SPECIFICSURVIVAL WHEN DIAGNOSED289%

The lifetime riskof dying fromcancer is 1 in 5 formen and 1 in 6 forwomen.4

Costs associated with treatinglate-stage cancers are

2-7x higher

than treating early-stage cancers.5

21%
LOCALIZEDMore than609,000 deaths
from cancer are
expected in theU.S. each year.4

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Total cost of cancer care in the U.S. will rise to$246 billion

by 2030, with some of the costliest
treatments targeting late-stage cancers.6
1Limitations of Current Cancer Screening
Recommended single-cancer screenings are powerful tools that can help nd cancer at an earlystage. While bene cial, however, there are limitations.

Cancers without widespread screening recommendations represent 71% of all cancer
diagnoses7 and approximately 70% of cancer deaths.8

Each single cancer screening test has a unique false positive rate; administering
multiple single cancer screening tests results in a high cumulative false positive rate.
An individual who receives all the recommended single-cancer screening tests in a yearwould have a cumulative false positive rate of 31% for men and 43% for women.9-13
Even if single screening tests—either as independent tests or a string of single-cancer
markers in a single test—were available for each individual cancer type, such an
approach would be impractical, inefficient, cost-prohibitive and would overwhelm
the healthcare system with false positive results.7

Potential of MCED Tests to Improve Cancer Outcomes
New approaches including MCED tests are needed to enable population-scale
screening to maximize the overall cancer detection rate. MCED tests complement
existing single-cancer screenings and represent the best chance to bend thecancer mortality curve.
MCED tests are designed to nd more cancers at early stages, minimize overdiagnosis and false
positives, and maximize ef ciencies by providing information to guide diagnostic workups.
They are designed to look for cancer signals in the blood. As an example, one MCED test uses
a targeted methylation, next-generation sequencing-based assay, analyzing cell-free DNA andutilizing machine learning to detect a shared cancer signal and predict the tissue type or organ
associated with the cancer signal. This enables clinicians to focus their diagnostic evaluation,
which can allow earlier treatment and may reduce healthcare costs.
Cancer signal
detectedcancer signal
origin prediction

Tumor sheds cfDNA
fragments intobloodstream

Blood plasma isolated(contains cfDNAfragments)

Targeted methylation
analysis of cfDNAa(sequencing, mapping,alignment)

Machine learningclassiﬁer

Cancer signal notdetected

cfDNA, cell-free DNA. aBisulﬁte treatment; targeted probes pull out fragments matching regions of interest. Adapted from Liu MC, et al. Ann Oncol. 2020;31(6):745-759. DOI:10.1016/j.annonc.2020.02.011.

To be used in a general population, MCED tests should have a high specificity of more than 99%
to ensure a low false positive rate; the ability to detect multiple cancers across stages; and theability to predict the tissue type or organ associated with the cancer signal with high accuracy tohelp guide next steps.14
MCED tests do not detect all cancers, and not all cancers can be detected in the blood.
Media Contacts

Trish Rowland: trowland@grailbio.com

Cammy Duong: cduong@grailbio.com

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References
1.

U.S. Preventive Services Task Force (USPSTF). Rockville, MD: U.S. Dept. of Health & Human Services, Agency for Healthcare
Research and Quality.

2.

Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence - SEER 18 Regs
Research Data, Nov 2018 Sub. Includes Persons Aged 50-79 Diagnosed 2006-2015 “Early/Localized” Includes Invasive Localized
Tumors That Have Not Spread Beyond Organ of Origin, “Late/Metastasized” Includes Invasive Cancers That Have Metastasized
Beyond the Organ of Origin to Other Parts of the Body. Noone AM, Howlader N, Krapcho M, et al. (eds). SEER Cancer Statistics
Review, 1975-2015, National Cancer Institute, Bethesda, MD, http://seer.cancer.gov/csr/1975_2015/, based on November 2017
SEER data submission, posted to the SEER website April 2018. Data on ﬁle GA-2021-004.

3.

American Association of Cancer Research. Modeled Reductions in Late-Stage Cancer with a Multi-Cancer Early Detection Test.
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searchresult=1.

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American Cancer Society. Cancer Facts & Figures 2023. Published online 2023. Accessible at:https://www.cancer.org/latest-news/facts-and-ﬁgures-2023.html.

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Reddy SR, Broder MS, Chang E, et al. Cost of Cancer Management by Stage at Diagnosis Among Medicare Beneﬁciaries. Curr MedRes Opin. 2022;38(8):1285-1294.

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American Cancer Society Cancer Action Network. The Cost of Cancer. Published online 2020. Accessible at:https://www.ﬁghtcancer.org/sites/default/ﬁles/National%20Documents/Costs-of-Cancer-2020-10222020.pdf.

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Hackshaw, A., Cohen, S.S., Reichert, H. et al. Estimating the Population Health Impact of a Multi-Cancer Early Detection Genomic
Blood Test to Complement Existing Screening in the US and UK. Br J Cancer. 2021;125(10):1432-1442.

8.

American Cancer Society Cancer Facts and Figures 2023. Available at: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-ﬁgures/2023/2023-cancer-facts-and-ﬁgures.pdf. Data on ﬁle GA-2021-0065.

9.

Pinsky PF, Gierada DS, Black W, et al. Performance of Lung-RADS in the National Lung Screening Trial: a Retrospective Assessment.
Ann Intern Med. 2015;162:485–91.

10. Wolf AMD, Wender RC, Etzioni RB, et al. American Cancer Society Guideline for the Early Detection of Prostate Cancer: Update 2010.
CA Cancer J Clin. 2010;60:70–98.
11.

US Food and Drug Administration. FDA Summary of Safety and Effectiveness Data (SSED). 2014. Accessible at:www.accessdata.fda.gov/cdrh_docs/pdf13/P130017b.pdf.

12. Lehman CD, Arao RF, Sprague BL, et al. National Performance Benchmarks for Modern Screening Digital Mammography: Update fromthe Breast Cancer Surveillance Consortium.
13. Kim JJ, Burger EA, Regan C, Sy S. Screening for Cervical Cancer in Primary Care: a Decision Analysis for the US Preventive Services
Task Force. JAMA. 2018;320:706–14.
14. Hackshaw A, Clarke CA, Hartman AR. New Genomic Technologies for Multi-Cancer Early Detection: Rethinking the Scope of Cancer
Screening. Cancer Cell. 2022;40(2):109-113. doi: 10.1016/j.ccell.2022.01.012.

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