First-of-Its-Kind Clinical Blood Test Predicts Cancer Patient’s Response to ICI Immunotherapy

A first-of-its-kind clinical blood test predicts the likelihood of a cancer patient’s response to an essential, widely used class of therapeutics – Immune Checkpoint Inhibitors (ICIs) – including anti-PD-L1 and anti-PD-1 immunotherapies.

Oxford BioDynamics Plc (Oxford, UK) has announced the successful clinical validation and US launch of its Checkpoint Inhibitor Response Test (EpiSwitch CiRT). The robust EpiSwitch qPCR blood test has demonstrated best-in-class performance, with high sensitivity (93%), specificity (82%), and accuracy (85%) across several ICI’s from multiple pharmaceutical companies and more than 15 key oncological indications.

Every cancer patient travels a unique path from diagnosis to treatment that requires making complex decisions with their doctor. Many patients are considered for ICI immunotherapy – an alternative approach to chemotherapy or radiation – that works with a patient’s immune system to fight cancer. ICIs have been the paramount breakthrough in cancer treatment and are now used against more than 15 types of cancer. However, typically less than one in three patients receiving ICIs shows any benefit; instead, many experience serious toxicity events affecting almost any organ as well as facing significant financial burden to pay for these specialized biologic medicines.

Rapid expansion of the checkpoint inhibitor class (with eight currently approved and many more in the review pipeline) has led to appeals by the FDA and leading oncologists for harmonization and coordination of the latest ICI developments. Robust and universal prediction of response to ICI treatment is seen as one of the key tools for harmonization: assisting physicians in their decisions on choices of treatment, protecting patients, leading to greater efficiency in drug development, reducing costs and protecting valuable resources. Oxford’s EpiSwitch CiRT enables doctors to make an informed decision on whether to recommend beginning or continuing treatment with an ICI. Using a routine blood test rather than an invasive biopsy, CiRT offers fast, personalized guidance.

EpiSwitch CiRT was built using Oxford’s well-established EpiSwitch 3D genomics platform, used to discover the most important drivers that determine a patient’s response to ICIs. For each patient, CiRT captures a personal fingerprint of their complex cancer genomic and immune system interactions. The EpiSwitch platform has been leveraged by leading pharma and clinical research teams for practical patient stratification in prognostic, predictive and early diagnostic applications across immuno-oncology, autoimmune and neurodegenerative indications

“Oxford Biodynamics Checkpoint Inhibitor Response Test (EpiSwitch CiRT) is a very important step forward for precision medicine. EpiSwitch CiRT directly links clinical outcome to gene regulation and with high accuracy predicts patient response. Since one in two of us will be diagnosed with cancer in our lifetime, it is essential to develop smart testing that can rapidly predict treatment response and guide us to the most efficacious therapies and maximize benefits for patients,” said Dr. Jon Burrows, CEO of Oxford BioDynamics. “In terms of the healthcare economics, ICIs alone cost the US healthcare system USD 17 billion annually. The ability to stratify patients based on their likelihood of response will enable the system to better manage these costs while allowing us to deliver smarter, better care to patients.”

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