New York State approval for commercial testing

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
Paul Pagano, CEO	Via Walbrook PR
David Anderson, CFO
Investec Bank plc (Nominated Adviser & Broker)	Tel: [phone]
Daniel Adams / Virginia Bull / Cameron MacRitchie
Walbrook PR Limited	Tel: [phone] or  [e-mail]
Paul McManus / Alice Woodings / Phillip Marriage	Mob: [phone]

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

 

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