Prostatype Genomics receives CAP laboratory accreditation, achieves another milestone towards entering the US market
Prostatype Genomics AB ("Prostatype Genomics" or "the Company") announces that its wholly-owned US subsidiary Prostatype Genomics, Inc. has been accredited by the CAP (College of American Pathologists) Laboratory Accreditation Program. The Company has thus achieved three major regulatory milestones in February 2024 towards entering the US market: a signed CLIA laboratory agreement with its lab partner ResearchDx, acquisition of a CLIA Certificate, and now CAP laboratory accreditation. The final regulatory step needed before being able to enter the US prostate cancer market is a formal technical validation of the Prostatype® testing service, which is ongoing and expected to be completed shortly. Furthermore, Prostatype Genomics is in discussions with leading American urologists interested in using the Prostatype® testing service when it becomes commercially available.
Prostatype Genomics is aiming to enter the US prostate cancer market with its Prostatype® biomarker testing service by offering it as a so-called LDT test. LDT stand for “Laboratory Developed Test” and makes it possible to launch the testing service without the lengthy process of achieving an FDA approval. At the same time, the Company is conducting an ambitious US study with Prostatype® to complete the data package needed for reimbursement approval by Medicare and commercial payers, with the aim of receiving Medicare approval by the end of 2024. This is the same path used by the existing genetic biomarker tests for prostate cancer in the US, which are already approved for reimbursement by Medicare (the current Medicare reimbursement rate is 3,784 USD per test).
By securing a CLIA laboratory agreement with its lab partner ResearchDx, acquiring a CLIA Certificate, and now being accredited by the CAP, Prostatype Genomics has achieved three of the four major regulatory steps needed before entering the US market in very rapid succession. The fourth and final step, formal technical validation of the Prostatype® testing service, is ongoing and expected to be completed shortly. These achievements have been possible through the hard work of the Company’s team in Sweden and the US, with decades of relevant clinical and regulatory experience, as well as the important collaboration with ResearchDx, an experienced CLIA laboratory part. In comparison, it is not uncommon that the regulatory process before entering the US market takes several years to complete.
“I am pleased that we have been able to successfully achieve three of four major regulatory steps towards being able to enter the US market in rapid succession together with our CLIA laboratory partner ResearchDx. With only the formal technical validation of the Prostatype® testing service remaining, which we are confident to be able to complete shortly, we are now rapidly approaching the US market launch of our Prostatype® testing service,” says Prostatype Genomics’ CEO Fredrik Persson.
To make sure that the Prostatype® testing service is introduced in the US market in the most optimal way, the Company is in the process of signing collaboration agreements with selected leading American urologists. Such agreements will enable these urologists to use the Prostatype® testing service, as a part of their preparation to use Prostatype® testing in clinical practice for prostate cancer patients.
“Representatives from the Company is in the process of discussing potential collaborations with leading American urologists. The best outcome for us would be to start with a highly experienced, high-profile urologist to assist in pioneering Prostatype® in the US, and then add further collaborations as we rapidly build up to a broader commercial launch,” says Fredrik Persson.