US Food and Drug Administration (FDA) has officially approved Ultromics’ EchoGo® Amyloidosis, which is a clinical AI solution for echocardiography with the potential to revolutionize early detection of Cardiac Amyloidosis,
According to certain reports, this marks the first ever device enrolled in the FDA’s Total Product Lifecycle Advisory Program (TAP) to achieve marketing authorization. More on the same would reveal how this device was among 15 breakthrough cardiovascular devices to participate in the initial pilot launch phase of TAP, which has since expanded with 55 companies currently enrolled.
Talk about the Cardiac Amyloidosis condition, it translates to infiltrative cardiomyopathy in which abnormal precursor proteins aggregate to form amyloid fibrils that deposit within the myocardial extracellular matrix, resulting in a restrictive cardiomyopathy.
The two primary precursor proteins that form the predominant subtypes of Cardiac Amyloidosis are transthyretin (ATTR) and immunoglobulin light chains (AL). Going by the available data, Amyloidosis can affect the gastrointestinal, visual, renal, neural, cardiac, and musculoskeletal systems. Making it even more dangerous is how the disease often comes with non-specific symptoms that are hard to detect.
Not just that, current diagnostic tools, including traditional echocardiography, often fall short by not reliably connecting findings to specific clinical investigations for Cardiac Amyloidosis.
Now, to understand the significance of Ultromics’ latest brainchild, we must acknowledge how, when it comes to ATTR Cardiac Amyloidosis, patients diagnosed with end-stage (stage III) versus early-stage (stage I) disease have a median survival time of approximately 2 years compared to about 5.8 years.
Similar to that, patients diagnosed with end-stage (stage IV) versus early-stage (stage I) AL Cardiac Amyloidosis have median survival time of 0.4 years compared to 4.6 years. These numbers indicate that early diagnosis of Cardiac Amyloidosis can dramatically reduce the debilitating nature of the disease and may extend survival even further with access to appropriate therapy.
“Echocardiography is a powerful tool for evaluating cardiac structure and function and is central to the detection and monitoring of disease. However, there are some diseases that are very challenging for even the most expert clinician to detect on an echocardiogram. Requiring only a single apical 4 chamber image, EchoGo® Amyloidosis identifies Cardiac Amyloidosis, and will help drive earlier access to appropriate treatment and care for patients with this underdiagnosed disease,” said Ross Upton, PhD, CEO and Founder of Ultromics.
But how will EchoGo® Amyloidosis solve such a problem? Well, the answer resides in how it is specifically tailored to address common diagnostic challenges in this underdiagnosed condition. In essence, solution leverages standard echocardiogram images to enable clinicians to identify potential cases with enhanced accuracy and efficiency, requiring only a single apical 4-chamber echo video clip.
EchoGo® Amyloidosis has also gone to show encouraging results during the initial deployment. For instance, EchoGo® Amyloidosis demonstrated 84.5% sensitivity and 89.7% specificity within the target population of individuals aged 65 and older with heart failure. Apart from that, the device was able to achieve constant performance across key Amyloidosis subtypes, with sensitivity rates of 84.4% for AL Amyloidosis, 85.8% for Wild-type Transthyretin Amyloidosis (TTRwt), and 86.3% for Hereditary Transthyretin Amyloidosis (TTRv). This shows the system’s broad applicability across different forms of Amyloidosis.
Furthermore, upon being placed in a subgroup analysis matched for age, sex, and ventricular wall thickness, EchoGo® Amyloidosis maintained excellent diagnostic performance, achieving 83.4% sensitivity and 90.6% specificity, confirming its reliability when compared to phenotypically similar controls.
In case that wasn’t enough, EchoGo® Amyloidosis demonstrated 100% repeatability, meaning that the system produced the same diagnostic output when analyzing the same image multiple times.
Among other things, we ought to mention that EchoGo® Amyloidosis will be a part of Ultromics’ EchoGo® platform. This includes linking up with a solution like EchoGo® Heart Failure device to provide a robust solution for diagnosing heart failure and its underlying causes.
For better context, Ultromics’ medical devices are software-only, manufactured internally, that use an image from a routinely acquired echocardiogram taken from a patient which is then used to report on the likelihood of the specified disease. They use artificial intelligence to produce a classification which is intended to inform clinicians on the likelihood of the disease.