The US FDA granted breakthrough device status to Freenome’s investigational blood test designed to triage high-risk adults for lung cancer screening.
The FDA has granted Breakthrough Device Designation to Freenome’s investigational SimpleScreen Lung blood test for adults at elevated risk of
The proposed indication covers adults aged 50 to 80 years with at least a 20 pack-year smoking history. A positive result would prompt low-dose computed tomography (LDCT), rather than provide a definitive diagnosis.
“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 Elliott, PhD, chief executive officer of
SimpleScreen Lung analyzes blood collected through a standard venipuncture. According to Freenome, the test combines cell-free DNA methylation and proteomic measurements with an artificial intelligence and machine learning–based classifier to determine whether a lung cancer–associated signal is present.¹
Under the proposed testing pathway, patients with a positive result would be referred for LDCT imaging. A negative result would not exclude lung cancer, and the company emphasized that clinicians would remain responsible for determining appropriate follow-up. The test is therefore being developed as a possible screening triage tool, not as a substitute for diagnostic imaging or tissue confirmation.
The FDA’s Breakthrough Devices Program is intended for devices that may offer more effective diagnosis or treatment of life-threatening or irreversibly debilitating conditions and meet additional statutory criteria. Designation provides access to interactive communication with the agency and prioritized review during a subsequent premarket submission. It does not indicate that the FDA has determined the device is safe, effective, or ready for clinical use.¹
Lung cancer remains the leading cause of cancer mortality in the United States.² LDCT is currently the only guideline-recommended lung cancer screening modality, but uptake remains limited. The company cited Centers for Disease Control and Prevention data indicating that approximately 18% of eligible US adults have undergone recommended screening.¹ Reported barriers include limited awareness, smoking-related stigma, fear of diagnosis, radiation concerns, and logistical or financial constraints.
A blood-based test could reduce some access barriers because blood collection is widely available. However, its clinical value will depend on sensitivity for early-stage disease, specificity, false-negative rates, and the number of downstream imaging procedures or invasive evaluations generated by positive results. None of those performance measures were reported in the designation announcement.
Freenome presented initial development findings at the 2026 American Association for Cancer Research Annual Meeting.³ The abstract citation confirms presentation of the investigational assay, but the press release did not provide cohort characteristics, prespecified end points, numerical efficacy findings, stage-specific sensitivity, or safety-related outcomes.
Prospective evaluation is continuing in PROACT LUNG (NCT06122077), according to the company.¹ Important unanswered questions include performance in a screening-intended population, comparison with LDCT-based pathways, adherence to follow-up imaging, and effects on interval cancers and lung cancer mortality.
Freenome said the assay builds on the methylation and next-generation sequencing platform used by its SimpleScreen CRC colorectal cancer screening test, which the company reported received FDA approval in July 2026.¹ SimpleScreen Lung additionally incorporates proteomic biomarkers. Its regulatory pathway, evidence requirements, and intended-use population remain distinct from those of the colorectal cancer test.
Until prospective data and an FDA premarket decision are available, SimpleScreen Lung should be considered investigational. The Breakthrough designation primarily marks an accelerated regulatory-development pathway rather than evidence that blood-based screening should replace or alter current LDCT recommendations.
