Ultromics, an Oxford University spin-out, has secured FDA clearance for its EchoGo® Amyloidosis, a clinical AI tool designed for the early detection of Cardiac Amyloidosis. This marks a significant advancement in diagnosing this underdiagnosed cause of heart failure, potentially revolutionizing patient care by enabling earlier intervention. EchoGo® Amyloidosis is the first device from the FDA's Total Product Lifecycle Advisory Program (TAP) to achieve this milestone.
Advancing Cardiac Amyloidosis Diagnosis with AI
EchoGo® Amyloidosis stands out as the first commercially available, software-only medical device that facilitates Cardiac Amyloidosis detection through echocardiography. Unlike traditional methods that require substantial clinical data, EchoGo® Amyloidosis uses a single, routinely acquired echocardiographic clip to identify potential cases. This streamlined approach promises to enhance diagnostic efficiency and accuracy, particularly in settings with limited resources or expertise.
Clinical Performance and Validation
Clinical data submitted to the FDA demonstrated that EchoGo® Amyloidosis achieved 84.5% sensitivity and 89.7% specificity in detecting Cardiac Amyloidosis within a target population of individuals aged 65 and older with heart failure. The device also showed consistent performance across various Amyloidosis subtypes, including AL Amyloidosis (84.4% sensitivity), Wild-type Transthyretin Amyloidosis (TTRwt) (85.8% sensitivity), and Hereditary Transthyretin Amyloidosis (TTRv) (86.3% sensitivity).
In a matched subgroup analysis, EchoGo® Amyloidosis maintained high diagnostic accuracy, with 83.4% sensitivity and 90.6% specificity when compared to phenotypically similar controls. Furthermore, the device exhibited 100% repeatability, ensuring consistent diagnostic outputs when analyzing the same image multiple times.
Expert Commentary
"Improving the detection of Cardiac Amyloidosis is vital as early detection provides the greatest therapeutic benefit for patients," said Prof. Sanjiv J. Shah, MD, Northwestern University. "Novel AI-based diagnostic tools such as EchoGo® Amyloidosis from Ultromics should help facilitate disease identification, particularly in clinics and hospitals restricted by expertise and resource. With more therapies becoming available, the FDA approval of EchoGo® Amyloidosis is timely."
Addressing an Unmet Need
Cardiac Amyloidosis often goes undetected due to its non-specific presentation and overlap with other cardiac conditions. Patients with heart failure with preserved ejection fraction (HFpEF) are particularly at risk, with up to two-thirds of cases being missed. Early diagnosis is critical, as patients diagnosed at end-stage disease have significantly shorter survival times compared to those diagnosed earlier. For example, patients diagnosed with end-stage ATTR Cardiac Amyloidosis have a median survival of approximately 2 years, compared to 5.8 years for those diagnosed at stage I.
Integration and Scalability
EchoGo® Amyloidosis integrates seamlessly into existing clinical workflows, requiring no additional hardware. As a Software-as-a-Service (SaaS) model, it is highly scalable and can be rapidly deployed on a large scale. The device is part of Ultromics' EchoGo® platform, complementing the EchoGo® Heart Failure device to provide a comprehensive solution for diagnosing heart failure and its underlying causes. Reimbursement pathways are in place, with outpatient settings covered under Category III CPT Code 0932T, effective January 1, 2025, and inpatient use benefiting from coverage through NTAP XXE2X19.
