Mission of ToxGenSolutions
- Transferring novel technologies into biomarker-based tools for preventive medicine addressing three high impact pathologies: neurodegeneration, cancer, immunosuppression.
- Offering discouraged and frustrated patients, caretakers and industry a solution to the deadlock that currently has paralysed Alzheimer's research.
Opportunity for business development in a massive market
- Current research was proven irrelevant for human health (>95% failure in drug development) leaving >95% of the Alzheimer’s cases unaddressed.
- These cases are related to non-genetic risk factors (e.g. heavy metals, pesticides, volatile anesthetics, lifestyle diseases, among others) which have largely been neglected in the current research.
- The impact of the non-genetic risk factors can be investigated using methods that are well established in toxicology.
Definition of the problem
- Currently diagnosis of Alzheimer's is initiated at the time the patient presents with some degree of cognitive impairment. At that moment irreversible brain damage has occurred. The diagnostic procedure is subjective and slow (questionnaire), expensive (scanning) and painful (lumbar puncture).
- The problems related to this approach are several:
- Accuracy is estimated to be <50%, meaning that probably less than half of the individuals with Alzheimer's are identified.
- The diagnosis comes in a late and irreversible phase of the disease.
- The approach is expensive, painful.
What is expected?
- More accuracy: The current strategy for diagnosing Alzheimer's appears to have an accuracy of up to 50%, despite it concerns patients with memory disorders and thus clear brain damage.
- Early diagnosis: The late and inaccurate diagnosis is considered the reason for the high failure rate (> 99%) during drug development and the absence of options to improve the quality of life of patients and their families.
- Inexpensive and Peripheral: There is a clear and urgent need for inexpensive and minimally invasive testing to more easily and accurately screen and identify patients in the earliest stages of the disease before irreversible injury and associated symptoms occur.
- Biomarker profiles: Clinical studies (e.g. for cancer) are twice as likely to be successful if patients are selected using validated biomarkers. This strategy must also be applied to Alzheimer's.
ToxGenSolutions can offer the solution to the problem:
- During recent years application of novel technologies has resulted in more human relevant approaches. ToxGenSolutions has the nonanimal tools to study in a human relevant way the impact of non-genetic risk factors on initiation and early development of Alzheimer’s.
- Application of tolls allowing for genetic biomarkers using cultured human neurons has resulted in a biomarker profile that has shown promise with respect to diagnosis of Alzheimer's disease in blood samples.
- The biomarkers represent events that occur very early after exposure of the cells to non-genetic risk factors.
- The test method is therefore a potential tool for
- Diagnostics: Exploitations of new (epi) genetic data describing the pathological processes of sporadic Alzheimer’s before irreversible brain damage.
- Therapy: Application of the novel diagnostics to identify drugs acting on the reversible pathology and reducing the current 99.6% failure rate for new drugs.
- A simple, cost-effective and minimally invasive method for diagnosing early phase Alzheimer’s, that eventually can be used as a screening test for persons of >60 years of age, allows for
- early enrollment in programs that slow the progression of the disease and therapy as soon as it is available.
- improvement of preclinical evaluation and clinical follow-up during drug development.
Market Focus: A market that is discouraged and frustrated.
- The primary markets for the diagnostic test include Diagnostic, Pharma and Biotech companies, as well as Contract Research Organizations (CROs) that are active in the field of neurodegeneration in general, and Alzheimer’s disease specifically.
- The envisaged earning models include test performance by TGS at a competitive price (CRO), license fees and royalties, and the sale biomarker kits.