Australian diagnostic company Minomic International has announced 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 Maryland based laboratory once internal validation is completed.
Minomic said finalising the agreement completes an important step in commercialising MiCheck in the world’s largest healthcare market.
According to CEO Dr Brad Walsh, offering MiCheck as an LDT through the partnership with Cirrus Dx will provide three important outcomes, including the collection of real-world data to be used as the basis for submissions to the FDA, validation of the clinical utility of MiCheck, and revenue from royalties.
"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," said Dr Walsh.
Minomic and Cirrus said they expect the required internal validation studies to be completed by the end of March 2019.