REG - LungLife AI, INC - First patient enrolment for LungLB® study

LungLife AIAnnouncement

02/02/2022 07:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20220202:nRSB3835Aa&default-theme=true

RNS Number : 3835A  LungLife AI, INC  02 February 2022

 

LungLife AI, Inc.

(the "Company" or "LungLife")

 

First patient enrolment for LungLB® 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® test in subjects presenting with indeterminate
lung nodules.

 

The multi-centre clinical study will be used to validate the LungLB® 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® 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 (https://www.lunglifeai.com/)
 Paul Pagano, CEO                                    Via Walbrook PR
 David Anderson, CFO

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

 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 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® 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 (http://www.lunglifeai.com)

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  RESFZGGZNMRGZZM