LungLife AI (LLAI ), which develops clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announced that 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, the company told investors. LungLife’s diagnostic solutions are designed to make a significant impact in the early detection of lung cancer.
‘Reimbursement in the US consists 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 Company informed shareholders.
It said the CPT® code marks ‘the first step’ on the path for commercial reimbursement.
Paul Pagano, LungLife’s CEO 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.”
LungLife’s core technologies are integrated in the LungLB® test, which is intended to be used as a tool to provide physicians with further 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 Company explained to investors that its 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.’
To date, 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%.
The Company said it is now ‘gearing up’ to proceed to a larger, multi-centre validation study to garner regulatory and reimbursement support and facilitate commercialisation.
In November 2021, LungLife announced that its clinical laboratory in Thousand Oaks, California had been awarded accreditation by the College of American Pathologists (CAP).
The Company, whose clinical laboratory was already CLIA certified, voluntarily sought the accreditation as part of its on-going commitment to maintaining best in class quality systems.
Lara Baden, VP of Clinical Operations, LungLife AI, said the accreditation “reflects our commitment to maintaining the highest standards of excellence in laboratory testing for patients and ensuring that our work practises meet the rigorous CAP assessment standards.”
This accreditation will provide ordering physicians and patients a further degree of confidence in the results they are receiving for our LungLB® test as well as for future products.”
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