Lunglife Ai Regulatory News (LLAI)

LungLife AI, Inc.(the "Company" or "LungLife")

CPT® Code granted by American Medical Association

Successful grant marks first step facilitating commercial reimbursement

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer announces it has been granted a CPT® Proprietary Laboratory Analyses (PLA) code for its LungLB® test by the American Medical Association (AMA). The new code has been approved and published by the AMA Editorial Panel and is scheduled to become effective on 1 April 2022.

Reimbursement in the US is comprised of three components: code, price, and coverage. CPT® codes offer health care professionals a uniform language for coding medical services and procedures, and the CPT® code allows clinical laboratories to more specifically identify their tests when billing Medicare and commercial insurers. The successful granting of a CPT® code marks the first step on the path for commercial reimbursement.

Paul Pagano, Chief Executive Officer, LungLife AI said: "A CPT® code is fundamental in the commercialisation of the LungLB® test. We were delighted with the AMA's decision as this will facilitate access to LungLB® for patients with indeterminate pulmonary nodules who are at-risk for lung cancer."

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About LungLife AI

LungLife is a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence. The Company's diagnostic solutions are designed to make a significant impact in the early detection of lung cancer.

The Company's technology is a combination of the recovery of rare cells and blood-based biomarkers shown to be altered in lung cancer. The Company employs machine learning to improve biomarker detection, and intends to build a deep, novel pool of lung cancer-related data for AI-enabled applications designed to improve its diagnostic solutions over time.

The Company's core technologies are integrated in the LungLB® test, which is intended to be used as a tool to provide physicians with additional information to help in the decision-making process for people with indeterminate lung nodules that may be lung cancer following a CT scan. There are estimated to be over 1.5 million individuals with indeterminate lung nodules diagnosed each year in the United States. The LungLB® test may have additional utilities, the most significant of which is likely to be in monitoring individuals for recurrence following surgical removal of cancerous lung nodules.

The Company has completed a 149 subject pilot study to evaluate the LungLB® test, which showed a well-balanced performance and a Positive Predictive Value of 89 per cent. The Company is now gearing up to proceed to a larger, multi-centre validation study to garner regulatory and reimbursement support and facilitate commercialisation.