Each year 234,000 Americans are diagnosed with lung cancer, tragically killing around 125,000.
However, the outlook for patients is improving, thanks to the launch of innovative new treatments such as immuno-therapies and ADCs, alongside the development of cutting edge diagnostics like LungLife AI's early stage LungLB blood test.
Indeed, LungLB has already successfully passed a pivotal 425 person, 17 site, validation study with flying colours under 'real-world' conditions, achieving a 81% positive predictive value (PPV) identifying smaller nodules (<15mm) vs 60% and 67% respectively for CT (current standard of care) and PET scans.
Small nodules are the most problematic area for the early detection of lung cancer and represent the greatest challenge for doctors. Moreover, LungLB outperformed the highly-validated Mayo Risk Model evaluation tool, with an area under the curve (AUC) of 72% compared to 62% for Mayo.
In similar fashion, LungLife AI today released 'in line' H1'24 results and positive guidance, meaning it has hit all major strategic and clinical milestones since listing on AIM in 2021 - a marvellous achievement that bodes well for the future.
Sure, the business remains loss-making with H1 EBITDA coming in at -$1.77m vs -$2.78m. Yet equally, initial orders for LungLB have just commenced via its Early Access Program (EAP) whilst net cash closed June at $2.62m, providing sufficient funding until at least Q2'25.
Additionally, LungLife AI plans to submit a Technical Assessment shortly to Medicare in order to obtain US insurance coverage, which will hopefully be granted sometime over the next 6 months.
The price has been set at $2,030/unit for the risk-stratification of indeterminate lung nodules. Medicare is the US government's healthcare insurance program for the disabled and elderly (ie >65 years old), representing 18.7% of the population or 67.3m people.
Elsewhere, the Board is seeking a strategic/licensing partner (eg Roche, Thermo Fisher, Natera, etc) to help commercialise the LungLB test firstly within the US and later worldwide. To me, this type of deal could be transformational and a significant win-win for everyone concerned.
It would not only provide LungLife AI with accelerated access to a much larger addressable market worth c. $2bn in the US alone, but also enable patients to benefit from the most accurate early-stage lung cancer diagnostic currently available, whilst offering the partner a unique test to sell as part of their broader product portfolio.
CEO Paul Pagano commenting: "We are delighted with the increasing recognition for LungLB as evidenced by the positive clinician feedback together with the first orders being received under our EAP. Whilst we progress towards commercialisation, we are also actively seeking opportunities for a suitable strategic partner who aligns with our vision and has the capability to accelerate the adoption of LungLB."
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