Abbott Launches Blood-Based CRC Test in Care Diagnostics

Abbott Commercially Launches SimpleScreen™ CRC Blood Test for Colorectal Cancer Screening in the U.S. 

Abbott Park, Illinois, U.S. September 30, 2026, Abbott (NYSE: ABT) has commercially launched SimpleScreen™ CRC, an FDA-approved blood-based colorectal cancer (CRC) screening test for average-risk adults aged 45 and older, marking a significant development within the Care Diagnostics Market. Developed and manufactured by Freenome and commercialized exclusively by Abbott, the test is designed to address a critical gap in colorectal cancer screening, with an estimated 60 million eligible individuals in the United States remaining unscreened. 

SimpleScreen™ CRC joins the stool-based Cologuard Plus test in Abbott's colorectal cancer screening portfolio, following Abbott's acquisition of Exact Sciences. The test detects colorectal cancer signals by analyzing circulating cell-free DNA from a standard blood draw, offering an alternative pathway for patients who decline or fail to complete preferred screening methods such as colonoscopy or stool-based tests. 

The test was evaluated in the PREEMPT CRC study, a prospective clinical validation study enrolling more than 48,000 asymptomatic, average-risk individuals aged 45 to 85 scheduled for routine screening colonoscopy. Colorectal cancer represents the second-leading cause of cancer-related mortality in the United States, underscoring the urgency of expanding accessible screening options. 

The global Care Diagnostics Market is projected to reach USD 84.3 billion by 2030, expanding at a compound annual growth rate (CAGR) of 8.7% from 2024 to 2030, according to Next Move Strategy Consulting. The commercial rollout of blood-based diagnostic tools such as SimpleScreen™ CRC reflects the broader industry trend toward accessible, non-invasive testing solutions that support early disease detection and patient-centered care. 

Key Highlights: 

• Clinical Performance: SimpleScreen™ CRC demonstrated 81.1% overall sensitivity for colorectal cancer, 63.5% sensitivity for Stage I CRC, and 90.4% specificity for advanced colorectal neoplasia in the PREEMPT CRC study. 

• Medicare Coverage: The test is covered under Medicare with no out-of-pocket costs for eligible Medicare Part B beneficiaries, broadening access for older adults. 

• Patient Navigation Infrastructure: Abbott is integrating the test into its existing patient navigation program, offering blood-draw coordination, bilingual outreach, translation services, insurance navigation, and repeat-screening tracking. 

• Flexible Sample Collection: Patients may complete sample collection through mobile phlebotomy at home or at participating clinical laboratories, reducing logistical barriers to screening. 

Analyst Insight: 

According to analysts at Next Move Strategy Consulting, the commercial launch of SimpleScreen™ CRC reflects a broader structural shift in the care diagnostics landscape toward decentralized, blood-based testing modalities. The integration of cell-free DNA analysis into routine screening workflows is expected to accelerate adoption among healthcare providers seeking to close persistent screening gaps, particularly among populations that have historically declined or been unable to complete colonoscopy or stool-based alternatives. 

NMSC analysts note that with the global Care Diagnostics Market on a trajectory to reach USD 84.3 billion by 2030, product launches that combine clinical validation, Medicare reimbursement, and patient navigation infrastructure are well-positioned to capture meaningful market share. The convergence of diagnostic innovation and healthcare access initiatives is likely to serve as a key growth catalyst across the sector through the forecast period. 

Industry Outlook: 

The U.S. commercial launch of SimpleScreen™ CRC signals a maturing phase in the blood-based diagnostics segment, where regulatory approval, payer coverage, and patient support infrastructure are increasingly prerequisites for market penetration. As clinical guidelines continue to evolve and healthcare systems prioritize early detection of high-burden cancers, demand for accessible, non-invasive diagnostic tools is expected to intensify. 

For the broader care diagnostics industry, this development reinforces the strategic importance of multi-modal screening portfolios and the growing role of molecular diagnostics in preventive care. Stakeholders across the diagnostics value chain from test developers and laboratory operators to payers and healthcare providers are likely to face increasing pressure to align their offerings with patient-centric, evidence-based screening frameworks in the years ahead. 

Source: Clinical Laboratory Products 

For More Information: Download FREE Sample on Care Diagnostics Market Report

Prepared By: Sanyukta Deb