PCDx™ - Process and Order

Use our 6 steps to obtain important diagnostic information for therapy design.

TherapySelect offeres the option of consulting before the tumor profiling is carried out. The aim is to determine, if a biomarker analysis is useful for a specific patient and inform about the strengths and weaknesses of the test as well as the order process. Furthermore, alternatives can be discussed. The PCDx™ is ordered by requesting the Patient Consent and Order Form through contacting TherapySelect via the Contact Form or via Phone / Fax / Email / Mail.

The Order:

To order the test we require the following documents:

• Laboratory Service Requisition Form (signed by the physician)
• Patient Consent and Patient Order (copy for TherapySelect, signed by the patient)
  There are two versions available depending which payment option one chooses:
  • Patient Consent and Patient Order (Payment via Credit Card)
  • Patient Consent and Patient Order (Payment in the Single Euro Payments Area, SEPA)

These documents should be sent back to us as fax, scan or mail.

If you have any questions regarding filling out the documents please do not hesitate to contact us via our Contact Form or via Phone / Fax / Email / Mail.

The following link contains the terms and conditions:

• Terms and Conditions

Further Information:

You can download all documents - among many other useful information - on our download website for PCDx™.

The treating physician has to fill out the PCDx™ requisition form to define the shipment of the tumor sample. There are three different options for sending the tumor to TherapySelect:

1. TherapySelect will take care of this step. In this case the tumor sample will be requested by TherapySelect - usually at the pathology department, in which the specimen is archived.
2. The treating physician or patient sends the tumor sample - ideally as FFPE (formalin-fixed paraffin-embedded) block - to TherapySelect by mail.
3. A fresh tumor sample can be sent directly after surgery to TherapySelect. TherapySelect will provide a specialized shipping kit.

TherapySelect ensures that after arrival the tumor is appropriately processed, packed and immediately shipped to the laboratory of Paradigm Diagnostics.

After receiving the tumor sample, Paradigm Diagnostics analyzes the requested molecular-based biomarkers by different molecular testing methods (immunohistochemistry (IHC), Next-Generation Sequencing (NGS) following highest quality standards. The receiving lab data is compared to latest clinical studies and critically analyzed and the efficacy of associated drugs is determined.

The detailed report of the biomarker analysis contains the

PCDx™ Report

which lists beside the approved drugs for the particular cancer type also drugs which are available in other cancer types or in clinical trials. If you are interested in receiving drugs within a clinical trial TherapySelect can assist you to select potential suitable clinical studies and an appropriate study center.

The PCDx™ Report is commented in every single case by an oncologist (from Paradigm Diagnostics) and, where required, additional literature references are added. Generally there is the possibility to talk with our oncologists about the report and to discuss the results.

The results are always sent by mail. In addition you can optionally choose receiving the report via fax and/or password-secured email attachment in the requisition form.

The treating physician receives the PCDx™ report in order to decide the next steps in therapy. There is the option for the treating pysician to contact oncologists from Paradigm Diagnostics in order to discuss the different therapy alternatives and get questions answered. In addition, the patient can get the report explained by TherapySelect before the medical consultation.

The actual therapy is determined in a personal dialogue between physician and patient and is performed afterwards.