Blood-Based Lung Cancer Screening Tool Earns FDA Breakthrough Device Status

SimpleScreen™ Lung, an investigational lung cancer screening test, has received breakthrough device designation from the FDA, according to a news release from the developer, Freenome, Inc.¹

What is SimpleScreen Lung, and how can it help detect lung cancer?

Developers designed SimpleScreen Lung as an artificial intelligence (AI)-powered multiomic test that detects early signals of lung cancer in a blood sample based on a standard blood draw. The device incorporates multiomics through methylation and proteomics technologies via an AI- or machine learning–powered classifier to determine whether a lung cancer signal has been found.

Although low-dose CT (LDCT) represents a guideline-recommended standard for lung cancer screening, common barriers to adopting this technology include strict eligibility criteria, lack of awareness among patients, social stigma surrounding smoking, fear of a cancer diagnosis, concerns regarding radiation exposure, and other logistical and financial hurdles. Designed as a non-invasive blood test, SimpleScreen Lung may help make lung cancer screening more accessible.

The breakthrough device designation supports the proposed use of SimpleScreen Lung among individuals 50 to 80 years old who have a 20 pack-year smoking history or longer and have no current participation in guideline-recommended lung cancer screening. As part of the proposed indication, a positive result via SimpleScreen Lung testing should be followed up with LDCT imaging. Additionally, a negative result does not necessarily rule out the possibility of lung cancer, as providers should still determine appropriate follow-up for each patient.

“The breakthrough device designation from the FDA recognizes the substantial unmet need for lung cancer screening and accelerates our path to bring SimpleScreen Lung to patients. By identifying high-risk individuals who would benefit from LDCT, we believe our test will complement the current standard of care and improve detection rates,” Aaron Elliot, PhD, chief executive officer at Freenome, stated in the press release.¹ “We continue to advance the clinical work necessary to submit SimpleScreen Lung for FDA review.”

What data support SimpleScreen Lung?

Investigators previously presented initial development data for SimpleScreen Lung at the 2026 American Association for Cancer Research Annual Meeting (AACR).² Across samples from 363 lung cancer cases and 310 cancer-negative controls, the multiomics test produced an intended use population (IUP)–adjusted sensitivity rate of 90.7% (95% CI, 86.8%-93.7%) at 50% specificity and 80.4% (95% CI, 75.4%-84.7%) at 75% specificity. At 50% specificity, the multiomics test’s adjusted sensitivity for adenocarcinoma and squamous cell carcinoma were 88.7% (95% CI, 81.4%-92.0%) and 91.1% (95% CI, 84.3%-96.1%), respectively. The data supported the conclusion that the multiomics test showed promising initial performance for blood-based cancer detection.

The SimpleScreen Lung test will undergo further evaluation as part of the prospective PROACT LUNG study (NCT06122077).³ The study’s primary end point will be sensitivity and specificity when detecting lung cancer.

Individuals 50 years or older within 30 days of enrollment who are currently smoking or have a cumulative smoking history of at least 20 pack-years are eligible for inclusion. Those with any active therapy for cancer, a history of any malignancy within 5 years of enrollment, or a blood transfusion within 30 days of enrollment are ineligible for study entry.

How else has blood-based cancer screening advanced?

In July 2026, the FDA approved SimpleScreen CRC, another blood-based screening option, for use among individuals 45 years and older at an average risk of developing colorectal cancer (CRC).⁴ The SimpleScreen CRC test was designed to detect CRC in the blood based on cell-free DNA. Data from the PREEMPT CRC study (NCT04369053), which assessed the test among more than 48,000 asymptomatic adults at an average risk of developing CRC, supported the device’s sensitivity and specificity for detecting disease.

References

1. FDA Grants breakthrough device designation to Freenome’s blood-based SimpleScreen™ lung cancer screening test. News release. Freenome, Inc. August 12, 2026. Accessed August 14, 2026. https://tinyurl.com/98dr9vjw
2. Shapira O, Lovejoy AF, González A, et al. Abstract 1107: Development and performance of a multiomics lung cancer screening blood test. Cancer Res. 2026;86(suppl 7):1107. doi:10.1158/1538-7445.AM2026-1107
3. Clinical validation of Freenome multiomics blood test for lung cancer screening (PROACT-LUNG). ClinicalTrials.gov. Updated August 5, 2025. Accessed August 14, 2026. https://tinyurl.com/22mvkz62
4. FDA approves Freenome’s SimpleScreen™ CRC blood-based screening test; Abbott to commercialize in the U.S. News release. Freenome, Inc. July 27, 2026. Accessed August 14, 2026. https://tinyurl.com/4ba5xswf