Minomic International Ltd is pleased to announce the company has executed an agreement with Cirrus Dx, a CLIA Certified “High Complexity” Laboratory, enabling US clinicians and patients early access to the company’s novel test for Prostate Cancer. The agreement allows Cirrus Dx to perform MiCheck® as a Laboratory Developed Test (LDT) in the company’s Rockville MD based laboratory once internal validation is completed. Finalising this agreement completes an important step in commercialising MiCheck® in the world’s largest healthcare market.
Minomic’s CEO, Dr Brad Walsh, noted “being able to offer MiCheck® as an LDT through our partnership with Cirrus Dx will provide the Company with three important outcomes, 'Real World Data' which can be used in subsequent FDA approval submissions, validation of MiCheck® and its clinical utility and finally, royalty revenues. Our thanks to the Cirrus Dx team for making this possible with special acknowledgement for the hard work and vision provided by Cirrus’ Kyle Armantrout. We are very excited to be working with them as they continue to build their franchise in the urological testing space”.
William M. Nelson, MD, Cirrus Dx’s President said “the ability of MiCheck® to improve the diagnosis of Prostate Cancer and, in particular, reduce the number of unnecessary biopsies being performed is a game-changer and we look forward to working with Minomic to bring this vital improvement into the US market”.
Minomic and Cirrus expect the required internal validation studies to be completed by the end of Quarter 1, 2019. Urologists and their patients in the US will have access to the MiCheck® test shortly thereafter. A suitable reimbursement code has been identified and both companies believe that appropriate reimbursement will be available. Commercial details of the agreement will remain confidential.
Minomic International Ltd is an Australian diagnostic company specialising in development of diagnostics for solid tumors, including prostate, bladder and pancreas. Minomic has developed the in vitro diagnostic MiCheck® test for the early detection of prostate cancer.
About Cirrus Dx
Cirrus Dx leverages emerging technologies to deliver superior diagnostic tools, supporting key clinical decisions. Extensive technical and clinical laboratory experience is the foundation of product development, which delivers CLIA laboratory services, IVD kits, and instrumentation that support vertical integration to advance patient care.
Copyright Business Wire 2019