Information for physicians
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.
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.
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., 2018, Wensink et al., 2021). Learn more about clinical trial data under Science.
Your benefits of the Reverse Clinical Engineering® test:
- Complementary diagnostic information for the best possible personalized therapy decision, provided to you in a timely manner in an easy-to-understand report (download sample report)
- Higher chances of an improved therapy response for your patient through modern precision medicine, which helps to avoid ineffective treatments as well as any potential undesirable side effects
- As ASC Oncology takes care of all necessary paperwork and logistics, it saves you time
- Sample collection during a scheduled surgery or biopsy makes it easy to implement into your clinical routine – your work and effort is reimbursed by the German health insurance companies
- Opportunity to increase your patient’s adherence to treatment through informed and participatory decision-making
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:
- Patients with progressive tumors with and without metastasis
- Patients with rare tumors for whom guideline recommendations achieve only modest improvement in progression-free survival and quality of life
- Palliative patients who may benefit from delayed disease progression and improved quality of life
- Undecided and initially dismissive patients who may benefit from treatment plans increasingly based on individual data, innovative or participatory methods
- Patients for whom an “individueller Heilversuch” (individual curative attempt*) or a compound’s off-label use may be an option
*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
Einschlusskriterien und Testspektrum
| 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) |
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:
- 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.
- 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.
- Medication selection You select the drugs to be tested.
- 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.
- 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.
- 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.
- 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.
- 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 2021 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-Buch, University Medical Center Göttingen, as well as the Medical University of Innsbruck and King’s College London.
Downloads and Services
Downloads
We have compiled relevant information and resources for you.
For your patients
Would you like to receive materials by mail or have them displayed in your doctor’s office? Simply fill out the form below.
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.
Collaborations
FAQ
We go one step further. Sequencing tumors, for example, can reveal changes in the genetic material that may be used as a target for treatment of your tumor. However, it’s not clear if the targeted treatment will work in your case. Recent studies have shown that only a fraction of patients (0.8 – 3%) have been able to benefit from a therapy chosen for its sequencing results (Tannock & Hickman, 2019). In contrast, ASC Oncology’s Reverse Clinical Engineering® uses a person’s own tumor model to directly test the cancer drugs’ efficacy. This allows a prediction to be made about how you will respond to therapy. Find out more about the test procedure under Science.
Your treating physician removes a small piece of cancer tissue during your surgery or biopsy and sends this directly to ASC Oncology’s laboratory. Our team of scientists multiplies the living tumor cells in the lab and grows “avatars” of your tumor, called ‘tumor organoids’. These avatars of the tumor can be used to test drugs that may be candidates for treating your tumor, allowing the most effective anticancer drug to be determined before therapy begins. Our results are an important decision-making aid for personalized anticancer therapy. Compared to following standard guideline recommended therapy, this approach has higher chances of treatment success. View a complete list of steps of the procedure here.
No, ASC Oncology does not replace your oncologist, but provides you and your doctor with additional information. Every patient and every cancer is unique. The results of the Reverse Clinical Engineering® test procedure will tell you and your oncologist which drugs are likely to be effective on your individual tumor. These additional insights increase the chance of receiving effective drug therapy right from the start and avoiding ineffective therapies along with potential side effects.
It varies. Depending on the quality of the tumor sample and the cancer entity, growing PD3D® tumor models can take different amounts of time. On average, the Reverse Clinical Engineering® test procedure takes 28 days from receiving the sample to preparing the final report.
Please do not send a sample without letting us know in advance. Please contact us at 0800 6988667 or use our online form to register a patient and send a sample. We will organize the pick-up and provide everything needed to transport it as quickly as possible – even for short-term requests. Take a look at our overview of the procedure.
ASC Oncology was founded in 2019 by leading scientists in the fields of pathology, biology, biochemistry, biotechnology, and tumor biology. We are an interdisciplinary team of experts, who together with lawyers and business information specialists, are dedicated in our fight against cancer and to advance precision oncology.
ASC Oncology benefits from years of expertise in 3D cell culture and the latest findings in the field of tumor organoid research through close collaboration with its sister company CELLphenomics, which was founded in 2014. In addition, we are supported by a top-class advisory board consisting of physicians, scientists, and patient representatives.