REG - LungLife AI, INC - New York State approval for commercial testing

LungLife AIAnnouncement

02/09/2022 07:00

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RNS Number : 0239Y  LungLife AI, INC  02 September 2022

 

LungLife AI, Inc.

(the "Company" or "LungLife")

 

New York State approves LungLB® for commercial testing

 

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung
cancer, announces that the New York State Department of Health ("NYSDOH") has
awarded LungLife a Clinical Laboratory Evaluation Program ("CLEP") permit
following their recent on-site audit, during which there were no deficiencies
found.

 

The CLEP permit allows LungLife to perform clinical utility studies and offer
the LungLB® test commercially in New York state, in addition to 46 other
states permitted by the Company's existing Clinical Laboratory Improvement
Amendments ("CLIA") certification.

 

This is an important step in LungLife's commercialisation plan, given its
relationship with the Icahn School of Medicine at Mount Sinai in New York, a
key site in the ongoing pivotal validation trial, and from which the Company
is now able to accept study participants in future utility studies. Securing a
CLEP permit is a requirement to consider participants from New York state in
the utility studies planned for 2023, from which the Company expects first
nominal revenues.

 

The audit was performed to ensure that the premises, laboratory practice,
equipment, personnel, and record-keeping methods meet state requirements.
Issuance of the CLEP permit follows a rigorous, independent scientific review
of both analytical and clinical data for LungLB®, as well as evaluation of
adherence to the Company's quality management system.

 

Lara Baden, VP of Clinical Operations for LungLife said: "We are pleased to
have received a CLEP permit from the NYSDOH. Not only does this provide
further validation of our best-in-class quality system, but also approval of
the LungLB® test means that LungLife can offer this service to physicians in
New York state who evaluate indeterminate lung nodules for early cancer
detection."

 

 

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 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)

 

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