FDA 510(k) clearance granted for AI-powered clinical decision support software for early lung cancer diagnosis

March 26, 2021

Optellum announced it received FDA 510(k) clearance for its Virtual Nodule Clinic. This 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.

Lung cancer kills more people than any other cancer. The current five-year survival rate is 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). By comparison, the survival rate for small tumors treated at Stage IA is up to 90%. 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.

Diagnoses of more small pre-symptomatic lung cancers earlier is presented by the two million patients in the United States every year who have a lung nodule identified incidentally during chest Computed Tomography (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, 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 enable 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 help 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 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 CT scanners, which are already available and the standard of care in every modern hospital.

Physician use of Virtual Nodule Clinic is shown to improve diagnostic accuracy and clinical decision making. In the clinical study which underpins the FDA clearance, all readers in the study, which included pulmonologists and radiologists of various levels of expertise, from generalists to experts, showed a statistically significant improvement in their accuracy for diagnosing lung nodules when using the Optellum software.

Optellum’s LCP has been extensively validated in additional multi-center studies led by co-authors of clinical guidelines and shown to consistently outperform conventional risk prediction models recommended in the current clinical guidelines and considered state-of-the-art in classifying nodules as low (likely benign), intermediate or high risk (likely cancerous). In an independent validation study led by physicians from Vanderbilt and Oxford, the AI was shown to correctly reclassify indeterminate nodules into high- and low-risk categories in more than a third of cancers and benign nodules7, illustrating the potential to speed up lung cancer diagnosis and reduce invasive biopsies and surgeries on patients without lung cancer, compared to the current standard of care.

Optellum has the release.