LungLife AI, INC First patient enrolment for LungLB(R) study (3835A)
February 02 2022 - 1:59AM
UK Regulatory
TIDMLLAI
RNS Number : 3835A
LungLife AI, INC
02 February 2022
LungLife AI, Inc.
(the "Company" or "LungLife")
First patient enrolment for LungLB (R) validation study
LungLife AI (AIM: LLAI), a developer of clinical diagnostic
solutions for lung cancer announces it has enrolled its first
patient in its pivotal clinical study to evaluate the LungLB(R)
test in subjects presenting with indeterminate lung nodules.
The multi-centre clinical study will be used to validate the
LungLB(R) test performance, looking to repeat the high performance
already observed in the pilot study completed earlier in the year.
The study will enrol 425 participants across multiple US sites,
including MD Anderson Cancer Center and Mount Sinai Hospital in New
York City, involving participants who present with indeterminate
lung nodules that would otherwise be scheduled for needle
biopsy.
It is estimated over 5m chest CT scans are performed in the US
each year with over 1.5m of them showing indeterminate lung
nodules, requiring further imaging or potentially unnecessary and
risky biopsy to determine whether they are cancerous.
This first patient enrolment confirms that the Company is on
track to enrol patients over the next 14 months, with study
completion expected in Q1 2023 and in-line with expectations. Study
completion is key to offering the test commercially through
LungLife AI's CLIA-certified laboratory, in addition to supporting
the Company's desire to pursue FDA submission.
Paul Pagano, Chief Executive Officer of LungLife, said : "I am
delighted that we remain on track with this key validation study
and first patient enrolment. This is an important milestone on our
journey towards the successful commercial roll-out of our
blood-based diagnostic test, which we believe is set to become a
driving force in the early detection of lung cancer."
LungLB(R) is an AI-enhanced, blood-based test to stratify
cancerous and benign lung nodules identified by CT scan, and is
designed to support a physician's decision to biopsy or to monitor
non-invasively using additional imaging. The test utilises
well-established FISH (Fluorescence in situ hybridization)
techniques to identify rare target cells isolated from whole
blood.
For further information please contact:
LungLife AI, Inc. www.lunglifeai.com
Paul Pagano, CEO Via Walbrook PR
David Anderson, CFO
Investec Bank plc (Nominated Adviser Tel: +44 (0)20 7597 5970
& Broker)
Daniel Adams / Virginia Bull / Cameron
MacRitchie
Walbrook PR Limited Tel: +44 (0)20 7933 8780 or LungLifeAI@walbrookpr.com
Paul McManus / Alice Woodings / Phillip Mob: 07980 541 893 / 07407 804 654 /
Marriage 07867 984 082
About Lunglife AI
LungLife AI is a developer of artificial intelligence-enhanced
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(R) test is designed to deliver additional information to
clinicians who are evaluating indeterminate lung nodules suspicious
for lung cancer. For more information visit www.lunglifeai.com
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