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Regulatory press release

Prostatype Genomics submits supplementary answers in the final phase of its Medicare application for reimbursement in the United States

13.02.2025, 12.00
Prostatype Genomics
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Prostatype Genomics AB announces that the company has compiled and submitted supplementary answers in the final phase of its Medicare application to get the prognostic genomic test Prostatype® approved for reimbursement in the United States. The compilation has been conducted in an efficient manner together with external partners in Sweden and the United States to create optimal conditions to complete the application process and get Prostatype® approved for reimbursement in the near future.

In the end of September, Prostatype Genomics submitted its application to Medicare (within the MolDX program) to get the genomic test Prostatype®, which is used for risk classification of established prostate cancer, approved for reimbursement in the United States. The application process is facilitated by the fact that the company is applying to include Prostatype® in an already existing category for reimbursement with an established payment level.

On January 3, the company announced that the application had reached its final phase, as a limited number of supplementary questions had been received following Medicare's processing of the full application. These questions were in line with what the company expected, and it has thus been possible to compile the answers in an efficient manner. To make sure that Medicare receives precisely the information requested, as clearly as possible, the company is collaborating with external experts in both Sweden and the United States.

“We are now taking another step in the final phase to get Prostatype® approved for reimbursement in the United States, and we are grateful that Medicare is doing a thorough review of our application. Considering the type of supplementary questions received, and the answers we have now submitted, we are looking forward to the next correspondence from Medicare with excitement,” says Prostatype Genomics' CEO Fredrik Rickman.

“At the same time, we are making encouraging sales related progress in the United States. A growing number of selected American urologists at different urology centres are using Prostatype® today, and they are ready to start applying for reimbursement for their Medicare-covered patients as soon as this becomes possible. This will in turn create sales revenue for us. When this moment arrives, we are also ready to initiate more comprehensive sales activities with an inhouse sales force in line with the communicated business plan,” says Fredrik Rickman.

For more information, please contact:
Fredrik Rickman, CEO Prostatype Genomics AB
Telephone: +46 (0)73 049 77 01
Email: fredrik.rickman@prostatypegenomics.com

About Prostatype Genomics AB
Prostatype® is a genomic test that is available to patients and treating urologists as a complementary decision basis for the question of treatment or no-treatment of prostate cancer. The test was developed by a leading research group at Karolinska Institute and is provided by Prostatype Genomics AB.

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Prostatype Genomics submits supplementary answers in the final phase of its Medicare application for reimbursement in the United States

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