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Would you like to improve your patient’s chances of receiving an effective cancer therapy?

Reverse Clinical Engineering® provides you with an innovative testing method that can be used to select effective therapies based on individual data and facilitate therapy decisions

Personalized therapy concepts are growing in importance. Molecular and genetic information on the tumor is already used to stratify patients more precisely and subsequently select appropriate therapies. Nevertheless, there is still a proportion of non-responders who do not respond sufficiently to established therapy regimens recommended in guidelines. ASC Oncology’s testing procedure can help to predict effective and ineffective drugs prior to treatment. It enables physicians to make the best possible therapy decision based on patient-derived 3D (PD3D®) tumor models and allowing more individually optimized treatments in the course of modern precision medicine. 

The most important facts in a nutshell: watch the video to learn how Reverse Clinical Engineering® can benefit you and your patients.

Reverse Clinical Engineering®

What is the Reverse Clinical Engineering® test procedure?

Reverse Clinical Engineering® is a personalized in vitro diagnostic tool based on patient-derived 3D (PD3D®) tumor models, so-called tumor organoids, which are generated in the laboratory from a fresh tumor tissue sample. The models are used to determine the individual response of the patient’s tumor to various therapeutic agents in vitro before treatment begins. In combination with genomic and proteomic data, it is possible to generate a comprehensive picture of the tumor’s biology. Find out more about the procedure under Science.

Steps of the Reverse Clinical Engineering® test procedure

Benefits

What additional benefit do I get from Reverse Clinical Engineering®?
ASC Oncology has developed Reverse Clinical Engineering®, a test to help physicians identify the best possible therapy for their patients. The method is based on PD3D® tumor models, which reliably represent the original tumor (Lancaster & Knoblich, 2014). These are used to study the efficacy of chemotherapies, immunotherapeutics, small molecules, and biologicals in vitro in an automated and parallelized manner. The method is currently recommended by the National Cancer Institute (NCI) as a “best practice approach” for drug testing (Boehnke et al., 2016). Tests with PD3D® tumor models have been shown to correctly predict drug inefficacy in up to 100% of cases and efficacy in up to 81% of cases in co-clinical studies (Vlachogiannis et al., 2018Wensink et al., 2021). Learn more about clinical trial data under Science.

Your benefits of the Reverse Clinical Engineering® test:

Suitable patients

Is my patient a good candidate?

The Reverse Clinical Engineering® test can be applied to all patients with malignant solid tumors requiring surgical resection, whose biopsy is in planning, and who are due to receive drug therapy. The use of PD3D® models to assess treatment response is particularly suitable for: 

* the application of an unapproved drug with the consent of the patient if, for example, other therapeutic options have been ruled out or have already been exhausted and the treating physician suspects a benefit based on scientific findings

Inclusion criteria and test spectrum
Tumor type
Malignant solid tumors (e.g., carcinomas, sarcomas)
Test material
Vital tissue from primary tumors or metastases obtained by resection or biopsy*
Stage
Stages I – IV
Timing
At any time with indication for systemic therapy
Substances
Cytostatics, targeted therapies, antibodies, drugs in off-label use, current investigational medicines, experimental / alternative / naturopathic medications As monotherapy or combination therapy in clinically relevant concentrations
Analysis
Cell growth, intratumoral heterogeneity, oncoproteomics (protein profiling of up to 120 tumor-relevant molecules)

* a minimum of two weeks should elapse between the last therapy cycle and sample collection

Implementation

How can I integrate the Reverse Clinical Engineering® test procedure into my routine?

Implementing the Reverse Clinical Engineering® test procedure into your patient’s upcoming or ongoing therapy is easy:

  1. Diagnosis Your patient is an eligible candidate for the Reverse Clinical Engineering® and you jointly conclude that the test is a useful addition as “individuelle Gesundheitsleistung” (IGeL = individual health service that is not covered by the German health insurance companies) for the subsequent therapy decision.
  1. Consultation and contract ASC Oncology counsels both you and your patient and will take care of all necessary formalities and provide support when there are queries.
  1. Medication selection You select the drugs to be tested.
  1. Tissue sample collection Surgery or a biopsy is planned to collect a sample of the tumor tissue for ASC Oncology, which also provides in advance the containers and transport box needed to ship the sample. ASC Oncology also organizes collection of the sample box and the return shipment. Take a look at the logistics in this info graphic.
  1. Reverse Clinical Engineering® test procedure Immediately after receiving the sample, it is used to create a PD3D® culture, amplify the tumor organoids, and test the selected substances. Please see Science for details on the procedure.
  1. Data analysis The results of the testing are evaluated and an individual tumor model sensitivity profile is generated for each substance tested. Learn more about the analysis under Science.
  1. Individual report Within an average of 28 days from receiving the sample, the final report is generated. The results are transmitted to you in encrypted form and in compliance with data protection regulations. Upon request, our experts will discuss the results with you and explain any questions. Look at an example report.
  1. Optimal therapxy decision With the final report, you will receive concrete therapy recommendations and a valid decision-making basis for selecting the best possible treatment for your patient. The results of the test should always be interpreted in context along with other clinical data.

Costs

How can I bill for the Reverse Clinical Engineering® test procedure?

Applying the Reverse Clinical Engineering® does not incur you any additional costs. You can bill the German health insurance companies for the sample collection and the findings review. In the OPS version 2023 of the Federal Institute for Drugs and Medical Devices (BfArM), this diagnostic procedure is coded under the code “1-990”. You can specify “1-990.1” or alternatively “1-990.2” for each individual tumor fragment you send in:

1-990: Ex vivo cell culture system for pre-therapeutic chemosensitivity testing incl. testing of up to 7 drugs;

1-990.1/2: By analysis of parameters of metabolism incl. ATP content or activity of the respiratory chain with dyes / of apoptosis incl. staining of dead or apoptotic cells or measurement of caspase activity.

Partnership with ASC Oncology

Can I permanently integrate the Reverse Clinical Engineering® test procedure into my everyday medical routine?

Are you interested in a regular partnership with us? Please get in touch and we will be happy to explain how we can integrate our service into your processes. The Reverse Clinical Engineering® test procedure is already being used successfully by a number of collaborators, such as Helios Clinic Berlin-BuchUniversity Medical Center Göttingen, as well as the Medical University of Innsbruck and King’s College London

Downloads and Services

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Do you have further questions?

If you have any further questions about diagnostics using tumor organoids and the Reverse Clinical Engineering®, please do not hesitate to contact the clinical liaison managers Dr. Sabine Finkler and Dr. Larissa Ruhe. Find answers to the most frequently asked questions in our FAQ.

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