What Changed at Freenome

Freenome launched SimpleScreen Lung, a laboratory developed blood test for adults 50 to 80 with a smoking history of 20 or more pack years who are not in guideline screening. It can be ordered alone or with SimpleScreen CRC from one blood draw. In an independent cohort of 172 cases and 436 controls it showed 85 percent sensitivity at 50 percent specificity and a negative predictive value of 99.8 percent.

Our read

Fewer than 20 percent of eligible adults are up to date with low dose CT, and a blood test is meant to bring more of them in. At 50 percent specificity, half of people without cancer will test positive, and the FDA has not reviewed the test.

Freenome released pivotal validation results for an updated SimpleScreen CRC blood test with assay and algorithm changes, presented at ACG 2026. Sensitivity for advanced precancerous lesions rose to 18.2 percent from 13.7 percent in the PREEMPT CRC study, and to 41.9 percent from 30.5 percent for lesions with high grade dysplasia, with colorectal cancer sensitivity of 80.4 percent at 90 percent specificity.

Our read

Catching precancerous lesions has been the weak point of blood based colorectal screening, and this is where the update moves the numbers. The FDA approved test is the first generation, so the updated version still needs its own regulatory path.