The Mitomic® Prostate Test (MPT™) Real-Time PCR Kit is a qualitative in vitro real-time polymerase chain reaction assay for the detection of the 3.4 kb mitochondrial DNA deletion and the 18S rRNA nuclear DNA sequence in human plasma isolated from a blood sample.
The test is for use in men 45 years and older with a Prostate Specific Antigen (PSA) concentration <10ng/ml to determine indication for prostate biopsy as part of the diagnosis algorithm for patients with suspected prostate cancer.
The MPT assay is to be used in combination with the QuantStudio 5 Real-Time PCR System (96 well, 0.2 mL) or with the Applied Biosystems 7500 Fast Real-Time PCR System or Applied Biosystems 7500 Real-Time PCR System.
The Mitomic® Prostate Test is intended for in vitro diagnostic use.
In order to view this kit's documentation, you must first read and agree to our End User Licence Agreement (EULA).
(the “Authorized Purposes”).
Without limiting the generality of the foregoing, the End User hereby agrees that it shall not, nor shall it permit any other person to use the IVD Kit for any commercial purposes other than as specifically authorized in this Section.
If I do not agree to the terms and conditions of this license, I understand that I will not be able to use the CE-IVD Kit. If already purchased, I will return the unopened CE-IVD Kit within seven (7) days of receipt to MDNA for a full refund.