Experts

Use of xken health in practice

xken health is based on clinical proteome analysis and provides you as the treating physician with molecular proteomic diagnostics for everyday practice. Most of your patients will not have had any exposure to this method to date.


The specifics of clinical proteome analysis


Every cellular process is controlled by proteins. The clinical proteome analysis defines all proteins and their fragments (peptides) in their complexity, the clinical proteome. These measured molecules are fragments of proteins, which are the building blocks of all cells and part of the machinery that keeps the cell alive. Every body has an individual proteome status that indicates its health status. xken health determines the body's proteome status and thus enables diseases to be detected early. The proteins control and regulate the entire molecular process and, with their specific mechanisms, also decide on diseases that arise. The defense mechanisms in the body use specific proteins to correct disease-specific development. If the body's own defenses are no longer sufficient or if they escape the control mechanisms, degeneration or disease mechanisms occur in the organic tissue or damage in the body itself. If these disease developments are recognized early, a variety of therapeutic measures are still effective. Drugs only work at the molecular level and only efficiently if they are administered in the early phase. Until now, chronic diseases in particular were only discovered with their organic effects based on significant loss of function in individual organs, such as the kidneys. A concrete definition is only made in pathology based on histological findings.

Checklist


A urinary tract infection or symptomatic nephrolitiasis can be ruled out.


An active infectious disease (e.g. flu or COVID-19) can be ruled out.


xken health is an individual health service (IGeL). You have taken all legal aspects into account.


The effect of drugs and metabolites on the test result has been extensively investigated. In individual cases, however, an influence cannot be ruled out.


Return shipping can be ensured within 48 hours including package delivery time after sampling.


xken health is a registered in vitro diagnostic device (IVD).

Note on stockpiling


In order to ensure a quick and smooth process for your patients, we recommend that you stock up on our test sets to hand over to your patients. If you regularly send in a lot of samples from your clinic, we will provide you with a sufficient number of urine collection tubes with stabilizer and shipping materials. Please contact us (med@xken-health.com).

A regular and, above all, independent check of your own health brings the greatest benefit. We recommend xken health to be repeated after two years at the latest, depending on body condition and age. Through regular checks, changes in your patient's body can be identified and the influence of other factors - e.g. B. Changes in lifestyle – can be determined.


Delivers xken health If there is evidence of the presence of a specific disease, we offer a more in-depth analysis using all proteome tests from our sister company that have already been proven in studies protexam GmbH at. Furthermore, an individual database can be set up for each patient upon request in which their results are made available.

4.950,00 €


xken health is used by the patient for the first time.

3.850,00 €


xken health is repeated as part of a check-up within 14 months.

850,00 €


Therapy control carried out annually.

350,00 €


First in-depth diagnostics if there is suspicion.

250,00 €


Any further, more in-depth diagnostics if there is suspicion.

Using clinical proteome analysis, a test was developed as part of a study (CRIT-CoV-U) that predicts a severe course of Covid-19. We incorporate the results of this work into xken health and offer users an evaluation that includes the predisposition to a Covid-19 infection.


The hypothesis of the medical scientists and biochemists involved is that the basis for a severe course of Covid-19 is already present in every patient. This individual overall disposition makes it possible to make an accurate prognosis for the course of a Covid-19 infection right from the start. xken health uses this proteome test from the CRIT-CoV-U study to find out the predisposition to a possible severe Covid-19 course before the infection. This hypothesis is based on knowledge of scientific principles.



In the case of a Covid-19 infection, the disposition test can be repeated so that the diagnosis can be confirmed. This enables the patient to behave in accordance with their personal risk and to take precautions for their health.

From the perspective of xken health - the health test - the scope of the test is expanded to include the prognosis of a severe course of Covid-19. Patient health is xken health's top priority and vital insights are provided for patient benefit to the practice. This analysis is therefore carried out free of charge for every xken health test ordered as 'off-label use' at the joint request of the patient and his doctor.

Medical background

Tissue weakness, cardiovascular or kidney diseases are all associated with biological age. This biological age is represented by its own molecular proteome pattern - the aging proteome.


The aging proteome is a molecular melting point of many diseases. From it, indications of chronic illnesses and the dynamic aging processes they trigger can be read.


Molecular diagnostics enables you to offer your patients an expanded spectrum of diagnostics. Early detection of imbalances in the body can be diagnosed in the development phase and the initiation of therapeutic measures can prevent further harmful development.

Molecular Mechanisms

Most protein fragments of the aging proteome are collagens. Collagens are massively responsible for the structural unity and the human body as a whole, e.g. B. as the main component of bones and connective tissue.


During all of the body's repair processes, collagen is produced and then broken down again. These repair processes must be precisely controlled by the body. Between all cells there is the extracellular matrix, which is not statically integrated into the exchange process of the cells at the molecular level, but is in a dynamic balance. If there is an imbalance in the dynamic equilibrium, this can lead to impaired wound healing and even fibrosis. Fibrosis can occur anywhere and in any part of the body. If undetected in organs, it leads to impairment of organ function and accelerates aging. Fibrosis creates scarred structures that prevent the cells from living properly. Early detection of such fibrotic structures, which is primarily due to endogenous or exogenous factors, can assist you in your patient examination. Changing your patient's behavior towards a healthier lifestyle can slow down negative tendencies.



Another disease phenomenon that affects the entire body and every organ is damage to the endothelium. The endothelium is a thin layer of endothelial cells that lines the interior (lumen) of blood vessels. It serves as a barrier to tissue, but is also involved in the regulation of the cardiovascular system. Endothelial damage can occur as a result of chronic illnesses or as part of fibrosis. Both fibrosis and endothelial damage have a massive impact on the patient's health status and their faster aging.

The disease-specific proteome patterns or the clinical significance of the individual components of xken health have been proven in clinical studies. As a rule, all disease-specific proteome patterns are associated with pathophysiology. Because of their high statistical significance and high study quality, the findings are very relevant and, together with the overall anamnesis, form a qualified basis for therapy.


xken health is very sensitive and can detect even slight changes in the proteome. Infections that have already been overcome (e.g. flu or Covid-19) are also shown and can influence the test results in individual cases. A comprehensive overall medical history is therefore absolutely necessary so that your patients can get the maximum benefit from an xken health diagnosis.



All components necessary for an xken health diagnosis have been validated in clinical studies. This includes the entire process, from the selection of the sample medium (urine) to the technology used (CE-MS coupling) to the proteome tests in use.

Relevant Study

BioAge and LifeSpeed

Martens DS, et al. Urinary peptidomic profiles to address age-relateddisabilities: a prospective population study. Lancet Healthy Longev.2021, 2(11):e690-e703.

HeartRisk

Campbell RT, et al. The novel urinary proteomic classifier HF1 hassimilar diagnostic and prognostic utility to BNP in heart failure. ESCHeart Fail. 2020, 7(4):1595-1604.

HeartRisk

Zhang ZY, et al. Epidemiologic observations guiding clinicalapplication of a urinary peptidomic marker of diastolic left ventriculardysfunction. J Am Soc Hypertens. 2018, 12(6):438-447.

HeartRisk

Zhang ZY, et al. Urinary Proteome and Systolic Blood Pressure asPredictors of 5-Year Cardiovascular and Cardiac Outcomes in aGeneral Population. Hypertension 2015, 66(1):52-60.

HeartRisk

Kuznetsova T, et al. Urinary proteome analysis in hypertensivepatients with left ventricular diastolic dysfunction. Europeanheart journal 2012, 33(18):2342-2350.

HeartRisk

Delles C, et al. Urinary proteomic diagnosis of coronary arterydisease: identification and clinical validation in 623individuals. J. Hypertens. 2010, 28(11):2316–2322.

KidneyRisk

Tofte N, et al. Early detection of diabetic kidney disease by urinaryproteomics and subsequent intervention with spironolactone to delayprogression (PRIORITY): a prospective observational study andembedded randomised placebo-controlled trial. Lancet DiabetesEndocrinol. 2020, 8(4):301-312.

KidneyRisk

Siwy J, et al. Proteomics and personalized medicine: a focus on kidneydisease. Expert Rev Proteomics 2019, 16(9):773-782.

KidneyRisk

Siwy J, et al. Noninvasive diagnosis of chronic kidney diseases usingurinary proteome analysis. Nephrol Dial Transplant. 2017,32(12):2079-2089.

KidneyRisk

Good DM, et al. Urinary proteomic diagnosis of coronary artery disease: identification and clinical validation in 623 individuals. J. Hypertens. 2010, 28(11):2316–2322.

OncoRisk

Siwy J, et al. Noninvasive diagnosis of chronic kidney diseases usingurinary proteome analysis. Nephrol Dial Transplant. 2017,32(12):2079-2089.

Before a disease becomes apparent through the appearance of certain symptoms and can be recognized using routine medical diagnostic procedures, it is preceded by changes at the molecular level. These are reflected in the composition of the protein pattern, which can be determined in urine using a state-of-the-art diagnostic procedure.


By determining the proteome in urine using capillary electrophoresis-coupled mass spectrometry (CE-MS) and then comparing it with proteome data from studies, it is possible to determine individual information as a snapshot of the current state of health in general and in relation to specific clinical pictures. Improvements in future individual health development can be achieved through changes in lifestyle and nutritional habits, the reduction of risk factors and through further targeted medical clarification of the findings.



Before permanent damage occurs, the patient has the opportunity to positively influence their state of health and future well-being. All statements from the clinical proteome analysis are based exclusively on the individual proteome status and are compared with the study results in individual cases. By repeating xken health, the success of therapy and the influence of other external influences or behaviors are also depicted in a scientifically understandable way.

One of the most important indications for determining aging, or the speed of life and its further course, is LifeSpeed. The LifeSpeed test is based on a proteome pattern, the so-called "death prediction score", which shows the patient's probability of survival in the next 5 years. For the underlying study, data from over 10,000 patients were evaluated and the survival data of the individual age groups due to internal causes were determined. The results indicate very precisely the chance of survival or the risk of premature death.


On this basis, you can propose a targeted intervention and attitude to the patient in order to reduce the risk of (early) death compared to the cohort of the same age, taking into account a personalized diagnosis.

Key data of the practical case:

Based on the data determined, the theoretical patient, with a chronological age of 65 years, has a chance of survival for the next 5 years of approximately 53%. This below-average probability of survival can be changed by selected parameters such as BMI, glomerular filtration rate (eGFR) and xken BioHealth test results using targeted intervention.

The changeable parameters are all directly or indirectly associated with chronic illnesses or previous negative phenomena. A therapy and its success can be checked in a qualified manner by repeating xken health.

If the causes for this test result are not obvious from the overall medical history, xken health can support you in finding a suitable therapy. This is about an optimized intervention so that changes are initiated in a targeted manner. These changes result in the risk of death being reduced from approximately 47% to 23%.


LifeSpeed


The score is a dimensionless, aggregated value that is derived directly from the extensive study results. Its outcome and the patient's expected life expectancy are statistically significantly linked.

Timing – before therapy


The theoretical patient has a BMI of 28 and an eGFR of 65. Further diagnostics with xken health show a chronic kidney disease score of 1.2 and cardiovascular risk of -2.2, which is in the risky range.

This means a chronic disease manifesting itself in the cardiovascular system, including the kidneys. As a result, xken health uses LifeSpeed to measure a (score = 6.38) below-average survival expectancy in the next five years (approx. 53%).

Measures


The patient is treated specifically to the problem areas diagnosed. At the same time, the patient adjusts his body weight (BMI = 27) and the treating doctor can therapeutically increase the eGFR rate (70).

Depending on the state of health and the overall medical history, it must be determined which therapeutic measures can still be exhausted.

Timing – after therapy


At the end of the therapy, the score for chronic kidney disease improves to 0.4 and cardiovascular risks to -0.2, so that the interim result is no longer in the risky range.

As a result of the therapy and measures, xken health uses LifeSpeed (score = 5.02) to measure an improved survival expectancy in the next five years (approx. 77%).

xken health For the practice

Individual therapy control

Clinical proteome analysis can demonstrate the success of therapy based on the defined disease-specific proteome pattern at all stages of the patient's treatment. Depending on the form of therapy, a more appropriate time interval should be chosen so that an improved dosage or a different choice of therapy can be made quickly.


Hardly any patient responds immediately to the therapy or dosage; often there are already other therapies that can cause intolerance. An exact anamnesis is the prerequisite for increasing the broad reservoir of knowledge in clinical proteome analysis. The patient benefits from the correct choice of therapy and dosage.



Compliance goes hand in hand with the treatment setting. If the lifespan with “LifeSpeed” is shorter than predicted, rapid and precise therapy adjustment is required. The patient's adherence to therapy is crucial for success. In these cases we recommend an annual check.

Positive test results:
Next Steps

xken health results are provided to you in a detailed laboratory report. This laboratory report prepares and classifies the results of the individual test modules. In order to derive an overall picture of your patient's health status, the previous illnesses must be taken into account appropriately. This is important because xken health is so sensitive that e.g. B. acute and recent infections can already be detected and can influence the overall result.


The detection of changes in the protein profile does not represent a classic medical diagnosis, but rather indicates highly significant molecular changes associated with the corresponding diseases, which are not detected in the early phase by routine medical diagnostics and may still be reversible with appropriate interventions. The further diagnostic and therapeutic consequences of this finding should be decided individually.



Do you have any questions or would you like to have a consultation in an individual case? Contact us and we will put you in touch with the doctors involved in the studies. These will be available to you by telephone after you have asked us your questions in writing. All further steps will be organized by our team - for the health of your patients!

Biological age


Biological age represents the current state of cell aging compared to the chronological age of a study group. This data can only be evaluated in combination with an anamnesis so that the cause can be investigated in detail and the patient receives an indication of his lifestyle.

LifeSpeed


Based on the cell age determined by the proteome, a comparison is made with the statistical life expectancy of the study group. This is used to determine the chance of staying alive in the next 10 years. This refers to life expectancy due to illness. The outlook can be improved in individual cases through targeted therapeutic measures.

Check thoroughly


An examination is carried out for coronary heart disease and heart failure, as well as chronic kidney disease. Positive results mean that there is evidence of a change with the associated diseases examined in the study group. As part of xken health's diagnostic service, we recommend carrying out further diagnostics with the affected patient.

OncoRisk


The statement should not be interpreted as a rigid prognosis, but rather as a consequence of the current health status, which can generally be influenced prognostically.

It may be an indication of systemic inflammation if there is no change in the protein profile that is attributable to a specific tumor (prostate, bladder, renal cell, pancreatic and bile duct carcinoma).

Exchange of experiences

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