Lunglife Ai Regulatory News (LLAI)

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

LungLife AI Clinical Laboratory achieves CAP accreditation 

Independent inspection confirms highest standard of care for laboratory patients

LungLife AI (AIM: LLAI), a developer of clinical diagnostic solutions for lung cancer enhanced by artificial intelligence, announces that its clinical laboratory in Thousand Oaks, California has been awarded accreditation by the College of American Pathologists (CAP). The Company, whose clinical laboratory is already CLIA certified, voluntarily sought the accreditation as part of its on-going commitment to maintaining best in class quality systems.

The Company's laboratory processes have been independently assessed by the CAP, the world's largest organisation of board-certified pathologists and leading provider of laboratory accreditation and proficiency testing programmes, during a recent on-site inspection designed to ensure the highest standard of care for all laboratory patients.

As part of this process, the inspectors examine a laboratory's records and quality control procedures, as well as laboratory staff qualifications, equipment, facilities, safety programme and overall management. The U.S. federal government recognises the CAP Laboratory Accreditation Program as being equal-to or more-stringent than the government's own inspection programme, and the Centers for Medicare and Medicaid Services (CMS) have granted the CAP Laboratory Accreditation Program "deeming authority," which allows for CAP accreditation in lieu of a CMS inspection.

Lara Baden, VP Clinical Operations, LungLife AI, commented: "We are proud of the recognition of our quality by the College of American Pathologists through receiving this accreditation, which reflects our commitment to maintaining the highest standards of excellence in laboratory testing for patients and ensuring that our work practices 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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About LungLife

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.