Internationale Partnersuche

Innovation & Technologie Angebot

Innovative methods in stress research: useful testing tools for clinical trials and for diagnostics in humans

Country of Origin: Germany
Reference Number: TODE20170904001
Publication Date: 8 September 2017

Summary

A German SME performing clinical trials for the pharmaceutical, healthcare and food supplements industry offers psychobiological methods to assess stress-related imbalance in humans. These methods comprise biological, psychological and symptom measures that facilitate the identification of neurobiological dysregulations in the stress response network. 
The company seeks industrial and academic partners for technical, research cooperation or commercial agreements with technical assistance.

Description

Based on internationally well-recognized neurobiological research and a long track record of successful co-operations with pharmaceutical, healthcare and food supplements industry, the SME offers the methods for three main fields of application:



(a) Clinical trials, showing efficacy of certain interventions

(b) In hospitals, clinics and patients, helping to achieve a      personalised intervention

(c) Preventive measures in operative healthcare management



Commercial agreements with technical assistance are possible on a fee-for-service basis. 



The company is also looking for technology or research partners, who plan to apply these methods and / or are interested in further developing a specific diagnostic tool already on the market as a test kit, for new fields of application. This might also include diagnostics for animals.



Whereas, most other stress diagnostics are mainly based on questionnaires, this test identifies endophenotypes, which can serve for personalised treatment approaches. Treatments include medical options (class of drug selection), nutritional and behavioural approaches.

Alongside specially developed questionnaires, the test set includes 16 saliva collection vessels for the measurement of the stress hormone cortisol in saliva, a low dose dexamethasone suppression test and a portable ECG. The ECG assesses heart rate variability, allowing an evaluation of the regulatory ability of the autonomic nervous system. The analysis of all the collected patient data provides an informed foundation for further treatment of the patient.



Application of the stress diagnostic kit: 

A physician completes a medical questionnaire and hands over the biomarker kit. At home, the patient completes the patient specific questionnaires, collects saliva samples over 3 consecutive days and wears the ECG overnight. The complete assessment material is then returned to the company for analysis. 



Using this method, 13 different stress endophenotypes can be differentiated to which specific treatment recommendations can be suggested. The patients benefit from this new diagnostic test by receiving personalized treatment recommendations for their specific stress condition. 



In addition to using the tool for the diagnosis of psychobiological endophenotypes of stress-related disorders, this system can also be used in clinical trials as follows:



• as an outcome measure assessing the impact of psychotropic  compounds on the CNS and help studying efficacy of   compounds on anxiety, depression and stress symptomatology in   humans



• as an innovative method in the design of clinical trials 



• as a tool for characterizing subgroups of patients or healthy  individuals in clinical trials and research studies. 



Based on the many years of research experience and its expertise in psychoneuroendocrinology, the company offers the following services:



1)

A laboratory for saliva testing services. The Saliva Lab serves as a center of excellence for the global leader in saliva testing assays. The following biomarkers can routinely be analysed: 17-OH progesterone, alpha-amylase, androstendione, cortisol, cotinine, C-reactive protein, DHEA, DHEA-S, estradiol, estriol, estone, IL-1 Beta, IL-6, melatonin, progesterone, secretory IgA, testosterone, and uric acid. The lab offers connected services as a consultation on how to time sampling, provides and prepares sampling material for patients and studies. Fields of applications are fertility, infertility, hormone balance, menopause, sleep, stress, burnout, etc.



2)

A “one-stop-shop” designing and performing clinical trials for OTC products of pharmaceutical companies and clinical studies for healthcare and food supplements providers. This includes a modern and quality controlled clinical site.



3)

Single services in the fields of clinical trial management, e.g. project planning, project management, monitoring, data management, biostatistics, medical writing and training.

Advantages and Innovations

The innovative diagnostic tool contributes to the advancement of personalised stress medicine and thereby facilitates the acceleration of effective therapies for stress related disorders.



The tool is an improvement of the standard stress diagnostic methods, which are commonly based on patient questionnaires only. By coupling the questionnaire with physiological data, such as the cortisol awakening response profile and the continuous electrocardiogram (ECG) monitoring of the patient over a 3 day period, the company has been able to more accurately diagnose stress and its possible physiological and psychological aetiology. 



Saliva testing has many advantages in comparison with other diagnostic testing methods:



- Salivary cortisol represents the free and biological active steroid fraction.



- The patients can conduct the sample collection at the required times at home, at their work place or during their leisure time. 



- It is easy and has been applied in toddlers, astronauts, patients, animals, etc. 



It is non-invasive and therefore does not pose risks to the patient. In addition it is affordable, fast and accurate. 



This diagnostic method stands out from the competitors for being more profound, complete and thorough, because it considers also data from the ECG, such as heart rate variability etc in order to make a more accurate diagnosis of stress, than e.g. measuring of cortisol alone.

Stage Of Development

Already on the market

Stage Of Development Comment

The diagnostic test has been developed already over many years and is based on comprehensive and reliable clinical data. However, it is subject to regular validation and shall be continuously improved or adapted to further studies.

Requested partner

Healthcare-, pharmaceutical-, food- and cosmetic industry and clinical/medical research organisations, public and private research organisations



Partners should be active in pharmaceutical research and development, development of food supplements and functional food.

Academic partners interested in behavioural research or social science.

The client or partner provides compounds, drugs or industrial products from which data about the psychotropic or anxiolytic properties should be collected.

The partner carries out case studies in single patients, larger epidemiologic or clinical studies and needs additional data about the stress relation of health disorders or the neurobiological pattern of patients or test persons