Exact Sciences Announces First Participant Enrolled in the CRANE Study, a Multi-Cancer Early Detection Clinical Evaluation in Japan
Landmark study led by Japan’s National Cancer Center to evaluate the performance of Exact Sciences’ blood-based MCED test
TOKYO, Japan — December 11 , 2025 — Exact Sciences, a leader in cancer screening and diagnostics, today announced that the first participant has been enrolled in the CRANE Study (Cancer Recognition and Assessment through Non-invasive Evaluation), a multi-center case-control study jointly conducted with the National Cancer Center Hospital East (NCC East), Japan.
The CRANE Study is the first large, multi-center observational study in Japan designed to assess the clinical performance of Exact Sciences’ blood-based Multi-Cancer Early Detection (MCED) test. The study will enroll approximately 2,000 participants nationwide, including 1,000 individuals with cancer and 1,000 without. The primary objectives are to evaluate the test’s overall sensitivity and specificity across multiple cancer types and stages. Additional analyses by cancer type and stage will provide deeper insights into performance within a Japanese population.
The Exact Sciences blood-based Multi-Cancer Early Detection test is the culmination of nearly a decade of development and is backed by rigorous science in partnership with top academic institutions. The test is supported by data from robust test-development studies, such as DETECT-A and ASCEND 2, involving more than 20,000 participants, including the first-ever prospective interventional MCED trial.1,2,3 The test, known as Cancerguard®, became commercially available in the United States this year.
“In Japan, approximately 980,000 people are newly diagnosed with cancer each year, and around 380,000 die from the disease.” said Takayuki Yoshino, M.D., Ph.D., Deputy Director and Head of the Division for the Promotion of Drug and Diagnostic Development at National Cancer Center Hospital East. “Using a blood-based MCED test, we aim to advance research toward the implementation of early detection across multiple cancer types.”
“The CRANE Study is an essential step toward generating Japan-originated clinical evidence for evaluating a new blood-based MCED test. Our goal is to provide reliable domestic data that support scientific discussions on cancer detection and future screening strategies suited to the Japanese population.,” said Tomonori Yano, M.D., Ph.D., Chief of the Division of Endoscopy at the National Cancer Center Hospital East.
“Exact Sciences is steadily advancing research and development in multi-cancer early detection,” said Tom Beer, M.D., Chief Medical Officer and Vice President of Multi-Cancer Early Detection at Exact Sciences. “Collaborating with leading institutions such as Japan’s National Cancer Center is essential to understanding our test’s performance across diverse populations, further validating its clinical performance, and supporting its broad adoption. The CRANE Study will help inform more proactive approaches to cancer detection and address gaps in existing screening programs. Like the smartphone redefined communication, MCED test has the power to redefine cancer detection and the future of early intervention.”
About the Cancerguard® test
The Cancerguard® test is a laboratory-developed test (LDT) that was developed and its performance characteristics validated by Exact Sciences Laboratories, LLC, an affiliate of Exact Sciences Corporation, under the regulations of the College of American Pathologists (CAP) and the Clinical Laboratory Improvement Amendments (CLIA). The test is performed at Exact Sciences Laboratories, LLC, located in Madison, Wisconsin, USA. The laboratory is CAP-accredited and CLIA-certified, and is authorized to perform high-complexity clinical testing.
The Cancerguard® test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). In addition, the Cancerguard® test is an LDT and is not an approved or certified medical device or in vitro diagnostic (IVD) product under Japan’s Pharmaceuticals and Medical Devices Act. Therefore, it has not obtained such approval or certification, nor has it been reported under the Act.
About Exact Sciences Corp.
A leading provider of cancer screening and diagnostic tests, Exact Sciences helps patients and health care providers make timely, informed decisions before, during, and after a cancer diagnosis. The company’s growing portfolio includes well-established brands such as Cologuard® and Oncotype DX®, along with innovative solutions like Cancerguard® for blood-based analysis of molecular information across multiple cancers and Oncodetect® for molecular residual disease and recurrence monitoring. Exact Sciences continues to invest in a robust pipeline of advanced cancer diagnostics aimed at improving outcomes. For more information, visit ExactSciences.com, follow @ExactSciences on X, or connect on LinkedIn and Facebook.
NOTE: Oncodetect and Oncotype DX are trademarks of Genomic Health, Inc., a wholly owned subsidiary of Exact Sciences. Cologuard and Exact Sciences are trademarks of Exact Sciences Corporation. Cologuard, Cancerguard and Oncodetect are currently only available in the United States.
Media Contact
Chitoze Yamada
GCI Health (Burson Japan)
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1. Lennon AM, Buchanan AH, Kinde I, et al. Feasibility of blood testing combined with PET-CT to screen for cancer and guide intervention. Science. 2020;369(6499).
2. Douville C, Hogstrom L, Gainullin V, et al. Design and enrollment for a classifier development study for a blood-based multi-cancer early detection (MCED) test. Presented at: ESMO Congress; October 2023; Madrid, Spain. Poster #FPN 189P.
3. Kisiel JB, Ebbert JO, Taylor WR, et al. Shifting the cancer screening paradigm: developing a multi-biomarker class approach to multi-cancer early detection testing. Life (Basel). 2024;14(8):925.