New York State approves LungLB® for commercial testing

September 2, 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.”

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