REG - LungLife AI, INC - Successful validation study results for LungLB®

LungLife AIAnnouncement

02/01/2024 07:00

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RNS Number : 2731Y  LungLife AI, INC  02 January 2024

 

LungLife AI, Inc.

(the "Company" or "LungLife")

 

Successful validation of LungLB® in multi-site, prospective clinical study

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for the
early detection of lung cancer, announces the successful validation of its
LungLB® test for indeterminate lung nodules from a prospective, multi-site
clinical study in the clinically important small nodules patient group.

 

In the study, LungLB® demonstrated:

 

·    A strong positive predictive value (PPV) of 81% in discriminating
benign from cancerous lung nodules in patients with smaller nodules (<15
mm). Smaller nodules are the most problematic area for early detection and
represent the greatest challenge for physicians. Current clinical standards of
care generate a ~60% PPV(1), leading to material delays in diagnosis of deadly
cancers.

·    This performance in smaller nodules, similarly demonstrated in
LungLife AI's lead-in study published in June 2023(2), typically represents
earlier detection capability and improved patient outcomes and highlights the
test's consistency.

·    The small nodule group in this study is of utmost importance because
it is comprised of ~87% "intermediate" risk nodules, which are the most
challenging to evaluate and diagnose. Previous studies lack sufficient numbers
of intermediate-risk nodules and is the reason why existing diagnostic tools
perform poorly in this group. We believe this will also be of significant
value to physicians.

·    In-line with a high percentage of intermediate risk nodules, the test
also outperformed the highly-validated Mayo Risk Model nodule evaluation tool,
which is a commonly used baseline comparator, with an area under the curve
(AUC)(3) of 72% for LungLB® compared to 62% for Mayo.

·    The results were also compared to Positron emission tomography (PET)
scan, another tool often employed in nodule evaluation clinics. LungLB®
outperformed PET by ~21% (81% vs 67% PPV) in the small nodule group, providing
physicians with a more robust diagnostic tool in this area.

 

"Small lung nodules measuring less than 15 mm are often dismissed as 'probably
benign' and monitored with serial imaging to avoid a potentially unnecessary
biopsy. Yet, as the results of the latest LungLB® study demonstrated, many of
these nodules are actually malignant and best managed with an immediate
biopsy and treatment initiation without delay. LungLB® performed remarkably
well in this validation study, warranting its consideration as a clinical
biomarker for patients presenting with indeterminate pulmonary nodules," said
Drew Moghanaki, MD, MPH, Professor and Chief of Thoracic Oncology at the
University of California Los Angeles (UCLA) Department of Radiation Oncology,
and Scientific Advisor to LungLife AI.

 

The validation study enrolled 425 patients across 17 hospital study sites who
were scheduled to receive a lung nodule biopsy, of which 347 provided data
that could be analysed. These results were driven by a 98-patient small
nodules (<15 mm) group, which represent a major challenge to physicians
practicing in lung cancer detection and treatment. When developing a precision
medicine test it is common practice to identify a specific indicated use in
order to maximise the impact on a given patient population, which in turn
helps physicians to know exactly when to use the test. The small nodules group
is the most important indication for LungLB®.

 

Paul Pagano, CEO of LungLife AI, said "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."

 

The study results are sufficient for publication and executing our commercial
programme for LungLB® under our CLIA license and New York State CLEP permit.
The initial launch of LungLB® will be through an Early Access Program in Q1
2024 as a Laboratory Developed Test offered from LungLife AI's CLIA laboratory
in California and with follow-on work to support utility studies through its
network of clinical investigators and early adopters.

 

(1) Lokhandwala T, et al. Costs of Diagnostic Assessment for Lung Cancer: A
Medicare Claims Analysis. Clin Lung Cancer. 2017 Jan;18(1):e27-e34. doi:
10.1016/j.cllc.2016.07.006. Epub 2016 Jul 21. PMID: 27530054.

(2) https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02433-4
(https://bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02433-4)

(3) AUC is a commonly used metric that demonstrates an aggregate measure of
performance and is useful in comparing diagnostic tests.

 

For further information please contact:

 

 LungLife AI, Inc.                                         www.lunglifeai.com (https://www.lunglifeai.com/)
 Paul Pagano, CEO                                          Via Walbrook PR
 David Anderson, CFO

 Investec Bank plc (Nominated Adviser & Joint Broker)      Tel: +44 (0)20 7597 5970
 Virginia Bull / Cameron MacRitchie / Lydia Zychowska

 Goodbody (Joint Broker)                                   Tel: +44 (0) 20 3841 6202 / +353 (1) 667 0420

 Tom Nicholson / Cameron Duncan

 Walbrook PR Limited                                        Tel: +44 (0)20 7933 8780 or LungLifeAI@walbrookpr.com
                                                           (mailto:LungLifeAI@walbrookpr.com)
 Paul McManus / Alice Woodings / Phillip Marriage          Mob: 07980 541 893 / 07407 804 654 / 07867 984 082

 

About LungLife

LungLife AI is a developer of clinical diagnostic solutions designed to make a
significant impact in the early detection of lung cancer, the deadliest cancer
globally. Using a minimally invasive blood draw, the Company's LungLB® test
is designed to deliver additional information to clinicians who are evaluating
indeterminate lung nodules. For more information visit www.lunglifeai.com
(http://www.lunglifeai.com)

 

About Lung Cancer

Lung cancer is the most fatal form of cancer worldwide and early detection is
critical to achieve better outcomes. Early detection involves the evaluation
of indeterminate lung nodules, of which there are over 1.5M identified by CT
scan each year in the United States alone. Evaluation often involves
significant unnecessary invasive procedures such as biopsy for patients with
benign nodules and long delays in potentially curative treatment for patients
with cancerous nodules that are selected for monitoring via non-invasive
imaging. LungLB® is intended to help with earlier diagnosis in the evaluation
process.

 

 

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