LungLife AI, the developer of an Artificial Intelligence (AI) enabled non-invasive liquid biopsy test for the early detection of lung cancer, announced today that the Company has received certification from the Clinical Laboratory Improvement Amendments of 1988 (CLIA). Under the “deemed status” provision of the US Department of Health and Human Services (HHS) Center for Medicare and Medicaid Services (CMS), the state of California has granted the company’s initial CLIA clinical laboratory license.
“Today’s CLIA certification marks a pivotal step towards the commercialization of leading cancer diagnostics for early-stage lung cancer. Our LungLB® test will provide a significant impact on patient outcomes and to clinical decision making. This CLIA certification is the natural next stage in becoming a lung cancer diagnostic leader.” said CEO, Sara Barrington.
ABOUT LUNGLIFE AI
LungLife AI is a cancer diagnostics company focused on transforming cancer diagnosis and management through artificial intelligence (AI) enabled the molecular analysis of cancer biomarkers in blood.
LungLife AI is focused upon lung cancer diagnostic solutions recognizing the need to substantially improve patient outcomes. The company's testing methodology is designed to deliver actionable information to clinicians via a minimally invasive blood draw. Our tests span all stages of lung cancer, from aid in diagnosis for patients with suspicious lung nodules as well as treatment stratification and monitoring in late-stage lung cancer.
The CLIA regulations include federal standards applicable to all US facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CMS regulates this testing in the United States through the CLIA. The Centers for Disease Control and Prevention (CDC), in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.