19 February 2019 | News
The agreement allows Cirrus Dx to perform MiCheck® as a Laboratory Developed Test
Australia based diagnostic company, Minomic International Ltd has announced that the company has executed an agreement with US based pathology laboratory, Cirrus Dx.
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 healthcare market.
Dr Brad Walsh, Minomic’s CEO said, “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, 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.