In collaboration with Karolinska Institutet in Stockholm, Prostatype Genomics has carried out an extensive validation process with the aim of significantly increasing the commercial and technical availability of Prostatype®, the genetic test that measures the aggressiveness of an individual patient's prostate cancer. By validating laboratory kits from additional suppliers as well as several instruments for RNA amplification, many more laboratories can now perform the test as the results from the validations turned out positive.
Prostatype Genomics CEO Fredrik Persson comments: "The fact that we have now completed the validation process carried out together with Karolinska Institutet, means that the number of test laboratories that can perform the Prostatype® test procedure increases dramatically. The opportunity for qualified testing laboratories anywhere to perform our test is one of our strongest competitive advantages, and by validating multiple testing platforms, we open the doors to those laboratories that have requested our test but did not possess the the previously validated equipment. We advance the positions significantly forward as we make the sales processes easier and more accessible. A central component of our offer is clearly strengthened both logistically and financially, which benefits both healthcare, laboratories and patients. The interest to start using Prostatype is significant in all markets we are present, both in Europe as well as in USA, and it is important that all logistical pieces of the puzzle is in place. I am happy to conclude that we have reached an important milestone both from a commercial as well as from a technical perspective which will be reflected in our sales efforts soon."
In the test laboratory, in a first step, RNA is extracted from prostate cancer biopsy tissue, and it is important that the extracted RNA is of high quality. Previously, two kits have been validated for use with the Prostatype® test; Maxwell 16 LEV RNA FFPE kit (Promega Biotech) and High Pure FFPE Micro (Roche).
In the now completed validation at Karolinska Institutet, four new kits have been validated:
AllPrep DNA/RNA FFPE kit (Qiagen),
RNeasy® FFPE kit (Qiagen),
Purelink FFPE RNA Isolation Kit (Thermo-Fisher Scientific)
FFPE RNA purification kit (Norgen Biotek).
The next step in the laboratory process is the use of a so-called RT-qPCR instrument to amplify the extracted RNA. As Prostatype® was developed using the Roche Lightcycler 480 I & II, it has continued to be used.
Now a total of four additional qPCR instruments are qualified to be used together with Prostatype®:
CFX96 Touch RT-PCR Detection System (Biorad),
7500 Fast Real-time system,
QuantStudio 5 Real-time PCR system
QuantStudio 12K Flex Real-time PCR system, all three from Thermo-Fisher Scientific.