In this day and age, it’s a tragedy how many people still die from lung cancer. In fact, according to the World Health Organization, the disease caused more 1.8m deaths worldwide in 2020.

Part of the problem is that sufferers are only diagnosed and treated once the condition has either spread, become metastatic or even terminal. Hopefully this is about to change.

Today LunglifeAI (LLAI) announced that it had completed the enrolment for its ‘blinded’ 425 patient pivotal study across 17 sites which began in February 2022. The trial aims to validate the accuracy its patented Circulating Tumour Cell based blood test (LungLB) & associated AI algorithms, which in a previous 149 person study achieved best-in-class performance (89% PPV vs 60% for CT scan). That result demonstrates its applicability both as a ‘Rule In’ (sensitivity) and a ‘Rule Out’ (specificity) test.

The next key task is to prepare and analyse the detailed results for release that should take between 3 and 4 months, after which, once published for peer review, LungLB would be used to stratify indeterminant lung nodules (1.6m pa procedures in the US alone) as either cancerous or benign following a CT scan. Crucially, that would help doctors decide whether or not to perform a biopsy of the suspected tumour. And there might be further important application areas, such as for treatment monitoring or companion diagnostics.

CEO Paul Pagano commented: "Completing enrolment is a considerable milestone along the path to commercialisation, and we are pleased that we continue to remain on-track with the timeline set out at IPO. We would like to thank our clinical investigators and their teams, and importantly the study participants, for taking part in our trial and for their continued support with study close-out."

Elsewhere, LungLife AI has already obtained national Medicare/Medicaid pricing at $2,030 a test and has been selected to join the prestigious US National Cancer Institute’s Early Detection Research Network.

First  revenues are expected in Q4 2023, underpinning house broker Investec's 221p a share target price - assuming an initial addressable market of 400k tests a year, worth $800m and supported by a cash runway that I anticipate should last until at least mid 2024.