Immune checkpoint inhibitor (ICI) therapy, which is now approved for use in most common cancers, represents one of the greatest advances in cancer treatment. However, ICImay cause immune-related adverse events (irAE) in some patients. These unpredictable, possibly severe, and potentially permanent toxicities occur when ICI causes an autoimmune attack on normal organs such as the liver, lungs, and GI tract. Years after ICIs entered the market, we still have no reliable means to diagnose, predict, or monitor these toxicities. Clinicians are therefore left guessing which patients may tolerate some of the most effective, and most toxic, ICI regimens, resulting in potentially avoidable morbidity and under-use of treatment. Moreover, once these toxicities occur, optimal treatment remains unclear, leaving many patients exposed to prolonged, high-dose steroids, which themselves may convey substantial toxic effects and delay administration of additional anti-cancer therapy.

OncoSeer’s multimarker tests will be game-changing for clinicians who prescribe ICI therapy. Using only a small volume of blood, the tests will provide a predictive score indicating whether a patient is at low or high risk for irAE. This information can be used to select ICI regimens and plan monitoring. Once patients start ICI therapy, tests may aid in diagnosis of irAE, which remain far more difficult to diagnose than are toxicities of other cancer treatments such as chemotherapy, radiation therapy, and targeted therapy.