OXFORD, England--(BUSINESS WIRE)--Optellum, a lung health company aiming to redefine early diagnosis and treatment of lung disease, today announced it received FDA 510(k) clearance for its Virtual Nodule Clinic. This revolutionary product is an AI-powered clinical decision support software for pulmonologists and radiologists managing patients with small lesions in the lungs called nodules that could represent early-stage lung cancer. This is the first such application of AI decision support for early lung cancer diagnosis cleared by the FDA.

Lung cancer kills more people than any other cancer. The current five-year survival rate is an abysmal 20%, primarily due to the majority of patients being diagnosed after symptoms have appeared and the disease has progressed to an advanced stage (Stage III or IV).1 By comparison, the survival rate for small tumors treated at Stage IA is up to 90%.2 The U.S. Preventive Services Task Force (USPSTF) updated their screening recommendations earlier this month with a push to diagnose lung cancer earlier when it is more amenable to treatment.

One of greatest opportunities to diagnose more small pre-symptomatic lung cancers earlier is presented by the two million patients in the United States every year3 who have a lung nodule identified incidentally during chest CT scans ordered for other reasons, such as emergency room or cardiac scans. Current guidelines mandate follow-up over one to two years to determine whether a nodule is cancerous. However, over 60% of these patients do not receive guideline-recommended follow-up,4 severely limiting opportunities for early intervention and treatment. Patients who do receive recommended follow-up often require multiple imaging scans and biopsies, and sometimes unnecessary invasive procedures including surgical biopsies and lung resections, before arriving at a definite diagnosis.
Optellum’s Virtual Nodule Clinic is designed to solve this problem by enabling pulmonologists to identify and track at-risk patients with suspicious lung nodules and make optimal clinical management decisions for those patients. The software features a clinically-validated Lung Cancer Prediction (LCP) score designed to empower clinicians to more accurately and consistently evaluate lung cancer risk and make more optimal clinical decisions that could save more patient lives. Optellum’s LCP score is powered by the world’s first FDA-cleared imaging AI/”Radiomics”-based digital biomarker for lung cancer. The score is computed from full patterns of 3D pixels in standard images captured by Computed Tomography (CT) scanners, which are already available and the standard of care in every modern hospital.

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