TEST:

Prostatype®

"Prostatype Genomics AB announces that its wholly owned subsidiary Prostatype Genomics Inc. has submitted its application for the Company's gene test Prostatype® to be approved for reimbursement by the Medicare healthcare system in the United States in line with the previously announced timeline. The Company continues to have Medicare approval in Q4 2024 as a business goal. The application is submitted within the MolDX program for molecular diagnostic tests. The US market is the world's largest single market for prognostic gene tests for diagnosed prostate cancer, with annual sales corresponding to approx. 2 billion SEK."

"Prostatype Genomics AB...announces concrete commercial progress in Spain following the presentation of positive data from a Spanish multicentre study with the genetic test Prostatype® in April. Agreements have so far been signed with around ten private healthcare providers in the country, of which some have started using the test commercially, and negotiations are ongoing with over ten university hospitals and additional private healthcare providers."

"Prostatype Genomics...announces that the retrospective multicentre study in Spain with the Company’s gene test Prostatype®, which includes 126 patients with prostate cancer at seven hospitals and is coordinated by the Spanish National Urology Association, has now been completed with strong positive results. The final results show that the treatment plan could have been modified for 39% of the patients if Prostatype® had been used as a decision basis at the time of diagnosis."

"Prostatype Genomics AB...announces 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."

"Prostatype Genomics announces that the company and Professor E. David Crawford, MD...will be the first US urologist with access to the Prostatype® testing service for clinical use. Providing early access and partnering with Professor Crawford in preparation for release nationwide will help ensure that urologist’s expectations are met when launching this next generation of prognostic testing to benefit patients battling prostate cancer."

This study demonstrates that a higher P-score is strongly associated with worse long-term outcomes, supporting the clinical utility of the Prostatype® test. This study also highlights that genomic assessment to predict tumor behavior is likely to improve risk stratification, to truly understand the cancer itself, to decide on the optimal intensity, type, and duration of treatment.

"Prostatype Genomics announces that the interim results from the long-term follow-up study with the genetic test Prostatype®, which is conducted by and in collaboration with Uppsala University Hospital, has been accepted for presentation at the annual AUA (American Urological Association) conference in the United States in May 2024."

"Prostatype Genomics AB...announces that its wholly-owned US subsidiary Prostatype Genomics Inc. has acquired a CLIA Certificate in its own name. Together with the announced CLIA laboratory agreement with Research Dx, this will enable the Company to enter the US prostate cancer market with its prognostic biomarker test Prostatype® upon accreditation from the CAP (College of American Pathologists) and formal technical validation of the Prostatype® test services. Prostatype Genomics expects to achieve these remaining steps and to initiate clinical use of Prostatype® test services in the US, in collaboration with selected American urologists, in Q1 2024."

"Prostatype Genomics Inc. and ResearchDx, Irvine, California, USA, has entered into an agreement where ResearchDx fully integrated clinical laboratory PacificDx will perform and run the Prostatype®-test in the US-market...Prostatype Genomics will offer its prognostic biomarker for diagnosed prostate cancer as a so called LDT-product in USA – similar to comparable products currently offered and reimbursed in USA."

"Prostatype Genomics has in collaboration with Akademiska University Hospital during 2023 initiated a comprehensive study in patients with localized prostate cancer over the course of 25 years. The study has been submitted to the prestigious and largest urology conference in Europe, the 39th Annual EAU (European Association of Urology) Congress. The congress received 5651 abstracts of various kinds, the highest number in many years...the new study from Akademiska University Hospital has been selected to present at the EAU Congress in Paris in May, 2024."

The confusion matrix and Matthews Correlation coefficient, (0.639) provides evidence that the ANN model manages false positives and false negatives correctly. Conclusions This study shows that the Prostatype® test is a strong independent predictor of AP at RP and may be used to guide decision making of clinicians and patients who are currently on or considering AS.

"Prostatype Genomics is currently conducting a study of 160 patients together with seven leading Spanish hospitals and the Spanish National Association of Urology. The initial results are very strong and show that approximately 60% of patients would have been reclassified if Prostatype® had been used for prognosis and treatment decisions after diagnosis."

"In a recently completed study at Chang Gung Memorial Hospital in Taipei (Taiwan), Prostatype® once again demonstrates superiority in assessing the aggressiveness of individual patients' prostate cancer, this time in Taiwan, which has the one of the most advanced healthcare systems in the world. The study has been presented at the South East Asian Urology Association conference..."

P=NA | N=316 | "In a recently published study conducted at Skåne University Hospital, Prostatype^® shows significantly better results in predicting death from prostate cancer within 10 years compared to both D'Amico and CAPRA, today's leading classification system for prostate cancer. The study was recently published in The Prostate, a leading peer-reviewed publication aimed at, among others, urologists and pathologists....The results shows that the P-Score has a significantly better ability to predict death in prostate cancer compared to the current standard methods, D'Amico and CAPRA."

Our findings provide evidence for the prognostic value of the P-score. The P-score predicted the risk for PCSM more accurately than the D'Amico and CAPRA scores. Performance was similar when predicting the risk for development of distant metastases within 10 years. Moreover, the P-score correlated with adverse pathological outcomes in RP specimens. Thus, the P-score could provide useful information for patients and their doctors to make informed decisions at the time of diagnosis.

"Prostatype Genomics begins collaboration with Eurofins Megalab...The agreement means that Eurofins Megalab will manage all steps in the laboratory process required to analyze the Prostatype® test on the Spanish and Portuguese markets. The collaboration is another step in Prostatype Genomics' work to further accelerate commercialization in Europe. The agreement will enter into force immediately."

"The study 'P-score in preoperative biopsies accurately predicts P-score in final pathology at radical prostatectomy in patients with localized prostate cancer' included 71 patients and aimed to compare the results obtained by using the gene test Prostatype® on tissue samples from biopsies before surgery, with 'fact', the gene expressions seen in the cancer cells after prostate cancer surgery...The results of the study are now published in the leading journal The Prostate, a peer-reviewed publication for original studies on prostate diseases with approximately a quarter of a million downloaded articles per year."

Our findings suggest that the P-score based on preoperative CNB accurately reflects the pathology of the whole tumor, highlighting its value as a decision support tool for newly diagnosed PCa patients.

"Prostatype Genomics said...that it has formed a commercialization alliance for its gene-based prostate cancer test with Swedish genetic testing provider Life Genomics...Under the terms of the nonexclusive deal, Life Genomics will manage the test process — which includes receiving referrals, performing the test, and reporting results — in all Nordic countries."