TherapySelect Dr. Frank Kischkel is an innovative biotechnology company based in Heidelberg, Germany, with a special focus on the development, validation and application of diagnostic tests for cancer patients. The company’s proprietary CTR-Test® uses patients’ cancer cells to determine the tumor’s susceptibility to treatment with cytostatic drugs. This knowledge helps identify ineffective drugs prior to treatment as well as reduce adverse drug effects and costs.
Cancer is a very personal disease. Due to progress in genotyping and automated sequencing methods that have increased the speed and reduced the cost of genomic analyses, it has become clear that cancer cells harbour many genetic changes, and that these changes differ in patients who appear to have the same type of tumor. In the same way as every human individual has a specific fingerprint, i.e. genetic profile, so do tumors. On average, any given prescription drug works for half of those who take it. So how can a physician tell whether a patient belongs to one group or the other?
Dr. Frank Kischkel has established TherapySelect in order to change this situation and increase the chances of a successful treatment outcome in cancer patients. TherapySelect has developed a chemotherapy resistance assay (CTR-Test®) which, as the company name suggests, enables a drug that has a high probability of treatment success to be selected.
The CTR-Test® is an in vitro test that uses living cancer cell samples from a patient and is carried out before the patient undergoes chemotherapy. The test identifies which drugs will be effective in treating the patient’s tumor. Ineffective drugs can be excluded right from the start and the patient can be spared a therapy that is both ineffective as well as associated with potential severe adverse drug effects.
The exclusion of ineffective drugs helps reduce costs for the healthcare system. But most of all, the information provided by the test helps physicians to select drugs with a promising therapeutic outcome: The treating doctor is able to tailor a treatment regime to a person’s unique cancer profile. Leading oncologists believe that the fight against cancer can only be won using diagnostic systems like the CTR-Test®, which determine a person’s susceptibility to drugs and hence increase the chances of cure.
The efficiency of TherapySelect’s CTR-Test® was validated with 32 drugs commonly used for the treatment of cancer, but its efficiency in identifying effective drugs will also soon be validated with targeted drugs. One of these type of drugs – tamoxifen, a drug used against certain type of breast cancer - has already been validated. Numerous clinical studies showed that the test has a predictive power of 95% in terms of identifying ineffective drugs before start of treatment. The test requires around one gram of vital tumour tissue or at least 250 ml of a malignant effusion. The result of the chemoresistance assay is available around six to nine days after arrival of the sample in the laboratory.
TherapySelect not only carries out its comprehensively validated CTR-Test®, but also distributes it to physicians and hospitals around the world. The company is currently undertaking a clinical trial called Predictor-Study funded by the German Ministry of Education and Research and aimed at assessing the effectiveness of new cytotoxic drugs for the treatment of patients with ovarian cancer. Recruitment of the patients was completed in January and initial results are expected by the end of 2016.
At present, the costs of the CTR-Test® are only reimbursed in case-by-case decisions by German statutory health insurance. The reason is that the health insurances demand clinical studies which are usally only required by drugs. These type of trials are extremely expensive. TherapySelect as a diagnostic company is unable to finance such trials on its own. This is a controversial issue and affects all diagnostics producers in the field of personalized medicine in general. In order to conduct such trials TherapySelect is interested in partnering with pharmaceutical companies. Its CTR-Test® is available worldwide as a diagnostic platform for the development of new anti-cancer products and for all phases of clinical development.
In addition to the CTR-Test®, TherapySelect also distributes a tumor profiling service called Caris Molecular Intelligence® from the US company Caris Life Sciences. The service analyzes biomarkers within cancer cells in order to find the most effective personalized anti-cancer therapy. Relevant biomarkers are therapy-relevant oncogenes in patients’ tumors, which are sequenced or their amplification in the genome is determined, and protein structures, which are associated with efficacy of drugs. The service also includes pharmacological information on more than 200 targeted anti-cancer drugs that are in clinical use or being tested in clinical trials and which are linked to these biomarkers as well as information on which of the 200 drugs are likely to be effective or ineffective for a particular patient’s tumor. The Caris Molecular Intelligence® service has the big advantage that formalin-fixed and paraffin-embedded tumor tissue samples used for pathological investigations can be used. No additional tumor sample has to be prepared.
The biomarker analysis by Caris Life Sciences is offered by TherapySelect in Germany. TheraySelect’s service provides more than the logistics for the test. Theyalso provide patient and physician advice on the interpretation of the test results. For instance: As part of the Caris Molecular Intelligence service the report gives information about the effectiveness of new drugs that are still in clinical development, but which may be alternative therapy options for patients who are unresponsive to existing cancer drugs. Patients who opt for such an alternative are given information on participation in one of the ongoing clinical studies.