Globally, lung cancer kills 1.8m people annually (135k in the US), primarily because many smokers are unfortunately diagnosed only once the disease has either spread or become metastatic.
This is hopefully about to change.
Today, LungLife AI (LLAI) announced that its patented Circulating Tumour Cell blood test (LungLB) had successfully passed its pivotal 425 person, 17 site validation study (commenced Feb'22) with flying colours. The study will provide doctors with a best-in-class diagnostic to detect early-stage lung cancer, in turn enhancing survival rates and reducing healthcare costs.
Indeed under "real-world" conditions, LungLB’s achieved a 81% Positive Predictive Value (PPV) in patients with smaller nodules (<15mm) vs. 60% and 67% respectively for CT (the current standard of care) and PET scans. Small nodules are the most problematic area for early detection and represent the greatest challenge for physicians. Moreover, the blood test outperformed the highly-validated Mayo Risk Model evaluation tool, with an area under the curve (AUC) of 72%, compared to 62% for Mayo.
So what's next?
Well initially LungLB will be targeted to stratify smaller lung nodules as either cancerous or benign following a CT scan, crucially helping doctors decide whether or not to perform a biopsy of the suspected tumour, and fasttracking treatment where required.
In terms of the size of the addressable market, its impossible to be too precise here, albeit as a rough estimate I suspect that c. 100k (worth $200m) of the 1.57m indeterminate nodules detected each year in the US are both small and relate to patients who would otherwise have had a tissue biopsy. This application area is just the start.
What's more, I believe LungLife AI still remains firmly on track to deliver 1st revenues this year, having already secured Medicare/Medicaid pricing at $2,030/test.
CEO Paul Pagano commenting: "The key finding from our validation study is LungLB performed strongly in participants with smaller lung nodules. This is where physicians consistently indicate the greatest unmet need and where currently available tools fall short. This important clinical validation of the LungLB test is a significant milestone for our Company. While we have identified small nodules as an early commercialisation opportunity - in the background we will continue to optimise the LungLB test for additional indicated uses, while progressing on the next stage of our programme."
Finally with regards to future funding, LLAI has a cash runway ($5.3m Jun'23) until at least Jun'24.
LLAI shares jumped 45% on the news.
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