Prostatype Genomics AB announced that the US study with Prostatype®, which includes approximately 1,200 patients with prostate cancer with a broad ethnicity coverage, is progressing significantly faster than expected. Approximately 40% of the entire study has already been completed. The Company will compile interim data from the study and apply to get Prostatype® approved for reimbursement in the United States by Medicare when approximately 150 African American patients have been analysed.

The Company expects to submit the Medicare application in Q2-Q3 2024 and receive approval in Fourth Quarter 2024. Currently, reimbursement from Medicare for genetic testing of patients with diagnosed prostate cancer amounts to approximately USD 3,800 per test. The sales for such gene tests in the US market today amount to approximately SEK 2 billion (SEK 200 million) per year, and the Company estimates that the total market potential in the United States is approximately SEK 6 billion.

Due to the high pace in the study, the Company is getting closer and closer to applying for reimbursement from Medicare and receiving an expected approval in Fourth Quarter 2024. The US study is also connected to the ongoing laboratory validation, which constitutes the final regulatory step before the Prostatype® is commercially available in the United States. The laboratory validation is also progressing according to plan, and it is expected to be completed shortly.