ResearchDx and Prostatype Genomics Inc. in CLIA-laboratory agreement for the US-market

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.

As previously communicated, 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. LDT stands for “Laboratory Developed Test” meaning that the product can be offered without an FDA-approval. What is required is a partnership with a CLIA-licensed laboratory holding the necessary permits and accreditations to run tests similar to Prostatype®.

CEO of Prostatype Genomics, Fredrik Persson, says: “We are obviously thrilled and very delighted to have reached an agreement with ResearchDx and its clinical laboratory PacifixDx to implement and run Prostatype® testing in USA. Prostatype Genomics has taken a significant and important step to commercially launch Prostatype® in USA during 2024. The board and management team at Prostatype Genomics has gone through an extensive process in order to take the right strategic decision for the company and its shareholders. The company has evaluated several different routes available to us, where the partnership with ResearchDx clearly stands out as the strongest. The option of setting up a Prostatype Genomics-owned and operated laboratory in USA has turned out to be far less cost- and time effective. Another option would have been to enter into a license partnership with an external laboratory where Prostatype Genomics would have given away a lot of freedom and flexibility to operate independently in the US-market. As previously communicated, USA is by far the most important market for Prostatype Genomics and I am personally very happy that we have been able to find an agreement with such a strong partner as ResearchDx. Their vast experience of running LDT:s in USA combined with the high level of professionalism in all areas surrounding our requirements gives us reasons to look forward to the ongoing rapid development of our US-operations. Time to market is essential and this agreement fits very well from a financial as well as from a timing perspective.”

Prostatype Genomics US President Steve Gaal comments: “A key milestone for Prostatype Genomics Inc. has been achieved by the agreement between ResearchDx and its fully integrated CLIA-accredited laboratory PacificDx. We are following our plan and executing on deliverables in order to launch Prostatype® in the US-market as quickly as possible. With the target to achieve reimbursement from Medicare before the end of 2024, we obviously need to be able to run Prostatype® within our borders, so the agreement with ResearchDx is truly a key milestone achieved. I am very pleased to have completed the agreement with the team at ResearchDx and we are looking forward to a long term collaboration.

Mathew W. Moore, PhD, Principal and founder of ResearchDx says: “At ResearchDx and our fully integrated CLIA-licensed and CAP-accredited laboratory, PacificDx, we are happy to enter into this partnership with Prostatype Genomics. The agreement is fully in line with our expertise and long experience in providing laboratory services, where Prostatype® is a perfect fit for us. With already existing accreditations, staff, equipment and regulatory framework in place, we will deliver the expertise required by Prostatype Genomics.”

About Research Dx:

Founded in 2008, Philip D. Cotter, PhD and Mathew W. Moore, PhD established ResearchDx as the first CDO (diagnostic-focused CRO) business model to integrate and manage all IVD diagnostic development expertise and services within a single organization. This decision was driven by the accelerating demands of personalized medicine. As a leading CLIA, CAP, and GLP-compliant molecular diagnostics laboratory, Researchdx dba PacificDx, provides diverse clinical and non-clinical testing and pathology services to support biopharma, diagnostic, medical professional, and IVD development needs. PacificDx offer customized diagnostic, analytical, and OEM assay and kit development and contract GMP manufacturing for a variety of applications. ResearchDx provide GMP/ISO13485 environments.

About Prostatype Genomics AB:

Prostatype Genomics AB manufactures, markets and sells the prognostic gene test Prostatype. By giving a comprehensive assessment of the aggressiveness of the prostate cancer, Prostatype helps clinicians and patients to make correct treatment decisions. Over and under treatment of prostate cancer can be minimized, the quality of life for the patient improved and money can be saved for the health care sector. Prostatype Genomics Inc. is a fully owned subsidiary of Prostatype Genomics AB.