The world is entering a golden era for healthcare. Driven by growing demand from ageing populations and emerging markets, revolutionary new technologies are emerging including advanced computer modelling, genomic sequencing, personalised medicine and break-through diagnostics.
 
The latter, in particular, are enabling killer diseases to be detected much earlier and far more safely and accurately, and in so doing improving patient outcomes and treatment regimes, alongside significantly reducing costs and waiting lists for healthcare providers. The advances represent a win-win on all fronts.
 
Take lung cancer as a case in point. This illness kills more than 1.8m people globally each yearm with nearly 80% of sufferers in the US alone being identified only when survival rates are low.

However thanks to medical innovations, new technologies could soon become available which ultimately identify 80% of cases early on. One such approach is being developed by LungLife AI (LLAI), which alongside full-year results said today that it was within 3 months of concluding enrolment for a pivotal 425 patient validation study across 14 sites for its patented Circulating Tumour Cell based blood test LungLB and AI algorithms.

In previous trials, LungLB has achieved best-in-class performance - delivering an 89% positive predictive value (PPV) versus 60% for CT scans – demonstrating its applicability both as a ‘Rule In’ (sensitivity) and a ‘Rule Out’ (specificity) test. Assuming the validation study rubber stamps these findings then  might eventually become the de facto standard in this largely untapped market. 

Here it will be used primarily to stratify indeterminant lung nodules as either cancerous or benign following a CT scan, helping doctors decide whether or not to perform a biopsy of the suspected tumour. On top, there might be further application areas, such as for treatment monitoring or companion diagnostics. Results from the study are expected in mid-2023.

Similarly, the company said it remains firmly on track to achieve its commercialisation goals, having already obtained national Medicare/Medicaid pricing at $2,030/test and been selected to join the US’ prestigious National Cancer Institute’s Early Detection Research Network. That's another major endorsement of the quality of LungLife's science.  
First revenues are expected in Q4 2023. 

CEO Paul Pagano commented: "We remain focused on completing our clinical validation study, commencing our clinical utility study later this year and expanding patient access to LungLB through implementation of our commercial reimbursement plan. We are very excited by the potential for LungLB to transform the early detection of lung cancer."
 
Prior to this morning’s ‘in line’ news, house broker Investec had a 228p/share target price - assuming an initial addressable market of 400k tests per year, worth $800m. In terms of funding, the company has a cash runway until at least mid 2024 (cash at the end of December 2022 stood at $8.0m versus $10.6m at the end of June).