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.

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.

Leaflet cover

For more information, download the The Mitomic Prostate Test EU CE leaflet

2.5MB

Documentation

In order to view this kit's documentation, you must first read and agree to our End User Licence Agreement (EULA).

Online End User Limited License (MDNA) Mitomic® Prostate Test Real-Time PCR Kit – IVD

  1. The Mitomic® Prostate Test Real-Time PCR Kit – IVD is an in vitro diagnostic product for the purpose of detecting the 3.4kb mitochondrial DNA deletion in human blood (“IVD Kit”) and all rights, interest and title therein, including know-how and other intellectual property rights, including various patents (1877559, E484589, 602006017534.50, 2006238390, 2606156, ZL2006800219031, 5537804, 101363032, 562928, 138638, 8896/DELNP/2007 (pending)) owned by MDNA Life Sciences Inc. (“MDNA”) or its licensors.
  2. MDNA hereby grants to you, the purchaser of the IVD Kit (the “End User”), a limited, non-exclusive, non-transferable, non-sublicensable license (the “End User Limited License”) in the field of prostate cancer identification, screening, and diagnosis in humans using blood (the “Field”), for use in your country of residence (the “Territory”), from the date of purchase until the last date on which the IVD Kit is used for the Authorized Purposes, as defined below (the “Term”) to:
  3. use the IVD Kit for non-commercial, internal research purposes; and
  4. use the IVD Kit solely to provide testing and test results for clinical use;

(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.

  1. End User hereby agrees to assign and assigns to MDNA any intellectual property rights (including know-how, techniques, discoveries, etc.) developed by the End User in connection with its research activities using or related to the IVD Kit including, without limitation, any improvements or modifications applied to, or developed in connection with the IVD Kit for the Authorized Purposes as well as any improvements or modifications applied or developed in connection with the IVD Kit based on use outside the scope of the Field or for purposes other than the Authorized Purposes. End User also agrees to do, or cause to be done, any acts requested by MDNA to perfect the transfer of the assigned intellectual property rights. End User hereby acknowledges and agrees that MDNA will retain, or obtain by virtue of the assignment hereunder, full ownership of any such intellectual property rights developed in connection with the IVD Kit.
  2. No rights of any kind are transferred by MDNA or its licensors or any other person to End User, pursuant to this End User Limited License other than as expressly set forth in Section 2 above in the Field, in the Territory and during the Term. For the sake of clarity, no right, interest or title in the IVD Kit or any intellectual property rights therein or associated therewith are transferred to End User or any other person hereunder.
  3. The IVD Kit has a durable life as noted on the Kit after which the End User must stop using the IVD Kit. The End User also acknowledges that the IVD Kit may only be used up to three times and may not be re-used, refurbished or resold in whole or in part.
  4. The End User hereby agrees that it shall not, nor shall it permit any other person to, use the IVD Kit for drug, diagnostic, or human use outside the scope of the Field. End User acknowledges that any use of the IVD Kit by End User, or any other person outside of the scope of the Field or the Authorized Purposes could result in irreparable harm being suffered by MDNA and that a monetary damage aware would not be an adequate remedy.  Accordingly, it is agreed that MDNA, in addition to any other remedy to which it may be entitled, shall be entitled to injunctive relief remedy to have any breach of this End User Limited License cease for the future, or to seek specific performance of the obligations contained in this End User Limited License.
  5. MDNA DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, MDNA DOES NOT WARRANT AS TO THE SUCCESS OF THE RESEARCH, TEST RESULTS AND/OR ANY COMPONENT THEREOF NOR THAT THE IVD KIT OR ANY RESEARCH CONDUCTED IN CONNECTION THEREWITH, WILL NOT OR DOES NOT, INFRINGE ANY THIRD-PARTY INTELLECTUAL PROPERTY RIGHTS.
  6. MDNA’s liability for any losses, damages or claims hereunder shall be limited to the amounts paid by End User to purchase the IVD Kit. End User hereby agrees to indemnify and hold harmless MDNA from any third-party claims related to the use of the IVD Kits or any research conducted using such IVD Kits.

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.

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