LungLife AI, INC New York State approval for commercial testing (0239Y)
September 02 2022 - 2:01AM
UK Regulatory
TIDMLLAI
RNS Number : 0239Y
LungLife AI, INC
02 September 2022
LungLife AI, Inc.
(the "Company" or "LungLife")
New York State approves LungLB (R) 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(R) 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(R), 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(R) 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
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 0 7867 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(R) test is designed to
deliver additional information to clinicians who are evaluating
indeterminate lung nodules. For more information visit
www.lunglifeai.com
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