- Business
- Prostatype Genomics AB (publ) develops, manufactures, markets and sells prognostic genetic tests for prostate cancer, primarily the CE-marked and IVDR-certified Prostatype test system, which analyzes gene expression from three stem cell genes in biopsy tissue combined with clinical parameters such as PSA levels, Gleason score and tumor stage to generate a P-score indicating risk of prostate cancer mortality; the Prostatype Genomic Classifier supports treatment decisions including active surveillance to minimize over- and under-treatment. The company, founded in 2007 as a spin-off from Karolinska Institutet in Stockholm, maintains headquarters in Solna, Sweden, with offices in Valencia, Spain, and Denver, Colorado, USA, manufacturing in Berlin, Germany, and a research lab in collaboration with Karolinska University Hospital; it listed on Nasdaq First North Growth Market in Stockholm in 2020 and operates in Europe commercially since 2022 with expansion into selected EMEA markets including Spain and Italy, while prioritizing the US market valued at up to SEK 6 billion annually. Prostatype Genomics holds ISO 13485 certification and conducts ongoing clinical studies across Sweden, Spain, Germany, Taiwan, China and the USA involving approximately 2500 patients, targeting urologists and healthcare providers for newly diagnosed low- and intermediate-risk patients. Recent developments include acquisition of a CLIA certificate by its US subsidiary Prostatype Genomics Inc. in late 2024 enabling laboratory-developed test sales and reimbursement pursuits, routine clinical adoption by US urologists with invoicing to private insurers commencing in 2025, submission of a Medicare reimbursement application in September 2024 now in final stages with approval anticipated in 2025 covering 60% of US patients, receipt of a SEK 1.3 million breakthrough order from Italy's Policlinico Tor Vergata in 2025, positive preliminary results from a primary US validation study, peer-reviewed publication of a health economics study demonstrating over SEK 600 million annual savings potential in Sweden, a rights issue of units raising approximately SEK 49.5 million in mid-2024 followed by high warrant exercise rates netting SEK 11.5 million in 2025, a 1:1000 reverse share split in late 2024, engagement of Healthcare Capital Mergers as US transaction advisor for strategic partnerships, and OTCQB Venture Market listing in March 2025.