Development Programs

Signature Oncology is in the process of concluding a development partnership with a leading diagnostics company that will assist the company in commercialising its IFNG test for melanoma in the Unites States, Europe and Australia.

Currently, there is only a single melanoma diagnostic test approved by the FDA, called FoundationOne CDx, which is approved as a companion diagnostic for patients with melanoma undergoing treatment with a BRAF inhibitor. The diagnostic was approved in late 2021 and was developed by Foundation Medicine, which was acquired by Roche in 2018 for US$2.4 billion.

The Company estimates the Stage III market for the Signature IFNG diagnostic to be worth US$71 million annually, with the stage II annual market opportunity worth US$143 million annually. The total addressable market is worth US$215 million per annum in melanoma and growing at 5% annually.

Signature Oncology believes a companion diagnostic such as the IFNG signature could potentially benefit patients who are unlikely to respond to such treatments from the harmful side effects of immunotherapies. All while reducing the significant cost-burden associated with the unnecessary use of such interventions, which will benefit both government and private payers within the healthcare system.

Signature Oncology is current considering the application of its novel IFNG signature profile across other cancers, where immunotherapies are considered a standard of care in advanced disease.