Dive Brief:
- Freenome has started a clinical trial to evaluate the ability of its blood test to detect lung cancer early in an at-risk population.
- The trial will enroll 20,000 current and former smokers aged 50 years and older who are eligible for screening with a low-dose CT scan. In 2022, 4.5% of eligible people were screened for lung cancer.
- The privately held company said in the announcement that its blood test could offer an alternative to CT imaging, which exposes people to radiation and has the risk of false positives. Freenome plans to use data from the study to seek approval for the test in the U.S.
Dive Insight:
By analyzing DNA, RNA, proteins and more using machine learning, Freenome is trying to find patterns in cell-free biomarkers that show a patient may have cancer. The company initially applied its multiomics platform to colorectal cancer. A 30,000-subject clinical trial of Freenome’s colorectal cancer completed enrollment and is scheduled to finish this month, according to ClinicalTrials.gov.
The company reported the start of a second study, this time in lung cancer, this week. Over the course of the trial, Freenome plans to enroll 20,000 people who are at high risk for lung cancer and eligible for screening.
Participants will give a blood sample for analysis and undergo a screening chest CT, ideally on the same day but potentially up to 45 days apart, according to the study’s page on ClinicalTrials.gov. Freenome will then track the subjects for at least 24 months. The primary endpoint looks at the sensitivity and specificity of the test in the detection of lung cancer at 12 months. A secondary endpoint evaluates the performance of the test over 24 months of follow up.
Freenome is running the study to support a filing for approval from the Food and Drug Administration. If approved, the test could provide patients with an alternative to CT screening.
The U.S. Preventive Services Task Force expanded its recommendation for screening in 2021, lowering the minimum age and reducing the level of smoking needed to qualify. Last year, the screening rate for those eligible was 4.5%, down from 5.8% in 2021.
The estimated primary completion date of the Freenome trial is June 2026.