The study will evaluate the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year period. Credit: THICHA SATAPITANON via Shutterstock.

The first patient has joined Exact Sciences‘ registrational multi-cancer early detection (MCED) Falcon registry real-world evidence (RWE) study.  

The multi-site study aims to enrol up to 25,000 participants aged 50-80 with no history of cancer, who will participate in annual MCED testing for three years and two additional years of follow-up data collection. The study will evaluate the clinical performance, patient and provider experience, and psychological impact of MCED testing over five years. 

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This study builds on successful data from the ASCEND-2 study, announced at the American Association for Cancer Research’s (AACR) annual meeting in San Diego in April 2024. The blood test achieved 50.9% sensitivity at 98.5% specificity across 21 cancer types. Additionally, sensitivity rose to 63.7% in the six types with the shortest five-year survival rate, including lung, ovary, and pancreas.

Exact’s MCED diagnostic uses a single blood draw to analyse circulating tumour DNA (ctDNA) for cancer-specific mutations. It focuses on methylation and protein biomarkers that capture common, cancer-associated signals, which are released into the blood through different biological mechanisms.

This study will provide valuable insight to further inform the development and commercialisation of the company’s future MCED test and support discussions with regulatory agencies, payers, and guideline bodies, said Exact. The US Food and Drug Administration (FDA) authorised an investigational device exemption (IDE) for Exact’s MCED test last month, allowing its use in the Falcon Registry. 

Wisconsin-based Exact has a range of different diagnostic tests, including Cologuard for colorectal cancer (CRC) screening. According to Exact, Cologuard has contributed around $22bn in cost savings to the US healthcare system since its inception in 2014. The company teamed up with Mayo Clinic in April 2024.

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The study’s principal investigator Ronan Kelly said: “With this important work, we aim to intercept cancer earlier than ever before. We are eager to do our part in the national effort to decrease cancer mortality by 50% over the next 25 years, as outlined in the US Government’s Cancer Moonshot initiative. This important study is helping advance proactive cancer detection efforts, and we are excited to help close gaps in existing cancer screening programmes.”