Prostatype Genomics announces very strong interim results from long-term follow-up study with Prostatype® in Uppsala
Prostatype Genomics AB ("Prostatype Genomics" or the "Company") announces that interim results from 180 of a total of approximately 500 patients in the ongoing long-term follow-up study at Akademiska University Hospital in Uppsala, Sweden, with the Company's genetic test Prostatype® show excellent accuracy for Prostatype® even after 20 years of follow-up time after diagnosis. None of the analysed patients classified as low risk by Prostatype® died from their prostate cancer during 20 years of follow-up time. The interim results from the Uppsala study, together with data from the ongoing US study with Prostatype® and data from other conducted studies, will be included in the Company's upcoming Medicare application in the United States with the aim to get Prostatype® approved for reimbursement in Q4 2024.
“We have previously announced promising interim results from this unique study, where patients with prostate cancer are followed up for at least 20 years from diagnosis. Now that we have completed more than a third of the study, and we continue to see 100% accuracy for Prostatype® when it comes to patients classified with low risk not dying from their prostate cancer during the next 20 years after diagnosis, I consider the interim results of the study to be remarkable,” says Prostatype Genomics' CEO Fredrik Rickman.
Complete interim data from the Uppsala study will be presented at the annual American Urological Association (AUA) conference in the United States in May 2024, one of the leading scientific conferences in the field of urology on a global level.
“Many urologists in the United States are showing great interest in starting to use Prostatype® as soon as we gain market entry in the United States, which is expected to be achieved shortly in parallel with our work to obtain Medicare approval for reimbursement. These very strong interim results from the Uppsala study, with a uniquely long follow-up period, will reinforce this trend,” says Fredrik Rickman.
The company's Medicare application to get Prostatype® approved for reimbursement in the United States, with expected submission in Q2-Q3 2024 and expected approval in Q4 2024, will include data from the ongoing US study, as well as data from other studies including the Uppsala study. The United States is the world's largest market for gene testing of patients with established prostate cancer, with current annual sales of approx. 2 billion SEK (200 million USD), and the Company estimates the total market potential in the United States to be approx. 6 billion SEK (600 million USD) per year.
The genetic test Prostatype® is used as a supplementary guidance for urologists when selecting treatment type for patients diagnosed with prostate cancer. Prostate cancer affects around one in eight men, of which approx. 50-90% undergo radical treatment. According to the Company's assessment, about a third of these radical treatments could be avoided or postponed if the patients were correctly risk-classified, and there is thus a great need for improved guidance when deciding on treatment type.
For more information, please contact:
Fredrik Rickman (formerly Persson), CEO Prostatype Genomics AB
Telephone: +46 (0)73 049 77 01
Email: [email protected]
About Prostatype Genomics AB
Prostatype® is a genetic test that is available to patients and treating urologists as a complementary decision basis for the question of treatment or non-treatment of prostate cancer. The test was developed by a research group at Karolinska Institutet and is provided by Prostatype Genomics AB. The Company’s Certified Adviser is Carnegie Investmentbank AB.