Mitomic® Prostate Test Real-Time PCR Kit CE-IVD

Mitomic® Prostate Test Real-Time PCR Kit CE-IVD

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.

This prostate cancer test is for use in men 45 years and older with a Prostate Specific Antigen (PSA) concentration <10ng/ml to determine the 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

A breakthrough liquid biopsy prostate cancer test with 100% negative predictive value.

The Mitomic® Prostate Test kits from MDNA helps add a greater degree of certainty to the testing pathway. It’s a simple, blood-based test independent of PSA. With a 100% negative predictive value, it’s the most accurate test available on the market.
It gives you and your patients the reassurance of a yes or no answer. Helping to better inform the need for invasive biopsy surgery in men with a PSA in the grey zone of less than 10.

Benefits:

•  Simple, blood-based test
•  Independent of PSA, age and family history
•  No algorithm
•  Negative predictive value 100%*
•  Sensitivity 92%*
• Accurate yes/no result
•  Affordable

How Mitomic® Technology works:

Mitomic® Technology unlocks the power of mitochondrial DNA. The mitochondrial genome is home to multiple copies of mitochondrial DNA, some of which become mutated beyond repair when cells are stressed by diseases such as cancer. The pioneering Mitomic® tests can detect this mutated DNA, which can accumulate from the very early stages of a disease, giving an unparalleled opportunity to accurately detect the disease before it even presents clinically