Many lab tests have failed during clinical validation, and BCAL...

Many lab tests have failed during clinical validation, and BCAL likely encountered the same issue. Because of its low specificity, the test cannot be used on its own—it needs to be an additional tool when another test doesn’t provide a clear result. The FDA may not approve it as a stand-alone test according to current standards. However, results in the USA might show higher specificity in certain groups, allowing for a better balance between sensitivity and specificity. Otherwise, BCAL would have to market it similarly to how the Galleri test is sold.