Regulatory press release
Prostatype Genomics has submitted additional responses in the Medicare review process – working meeting planned for November
Prostatype Genomics AB announces that this week the company submitted responses and clarifications to the latest questions in the ongoing process to secure Medicare reimbursement for Prostatype® in the United States. The questions concern a limited number of areas addressed in previous discussions, enabling the company to respond promptly. A working meeting within the MolDX program is planned for the first half of November 2026.
The application is being reviewed within the MolDX program and the existing reimbursement framework for prognostic genetic tests for localized prostate cancer. The responses now submitted represent the next step in the ongoing assessment of Prostatype®.
“We have been able to respond promptly to the latest questions as they concern a limited number of areas already addressed in previous discussions. Our focus is now on using the planned working meeting in November to review the questions and our responses, and to move the process forward. We continue to work toward our goal of obtaining a positive reimbursement decision as soon as possible and are ready to promptly provide any further clarifications if requested,” says Fredrik Rickman, CEO of Prostatype Genomics.
Prostatype® is a prognostic genetic test that complements existing clinical assessments in patients diagnosed with localized prostate cancer. The test provides physicians and patients with additional information to support the choice between active surveillance and treatment, such as surgery or radiation therapy. The aim is to support well-informed treatment decisions and reduce the risk of both overtreatment and undertreatment.
A positive Medicare reimbursement decision would represent an important commercial milestone for Prostatype Genomics and the company’s continued establishment in the US market.
The timing of a final decision is not yet known. The company will inform the market when further relevant information about the process becomes available.