Freenome books $183.5m quarter as colorectal test approval unlocks licence income

Freenome reported revenue of $183.5 million for the three months to 30 September 2026, with most of it coming from licence income. The company tied that income to the US Food and Drug Administration's 24 July approval of SimpleScreen CRC, its colorectal cancer screening test, which uses a blood sample rather than a stool sample or endoscopy.

The company said the approval triggered a $100 million milestone. The test is cleared for adults aged 45 and over at average risk of colorectal cancer. Freenome did not break down the rest of the licence revenue in the information available.

The quarter is large against the company's outlook. Freenome guided 2026 revenue to between $192 million and $194 million, so the third quarter alone is equivalent to roughly 95% of that range. By simple arithmetic, that leaves little room in the guidance for the other three quarters combined, which suggests the milestone-heavy quarter is a one-off rather than a run rate.

Commercial sales are now in the hands of Abbott, which launched the test in the US on 30 September. It did so under a licence agreement originally signed with Exact Sciences. Freenome has not given sales figures for the test.

Freenome also began selling SimpleScreen Lung in October. Its multiomics version of the lung test has received FDA Breakthrough Device Designation, which is a development status and not a marketing authorisation.