Every patient is unique – and your cancer treatment should be unique too.

How you can work with your oncologist and the Molecular Health Guide® (MH Guide) software to identify the appropriate drug-based treatment option for you.

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Access to customized treatment can make a difference for you


Cancer is an abnormal growth of cells. Cancer cells divide faster and more frequently than healthy cells. They reproduce on an uncontrolled basis, creating a mass of mutated cells. These malignant masses expand into surrounding healthy tissue and consume it. From wherever they originate, they can spread to other organs through the blood or vascular system, and they reproduce elsewhere in the body as metastases.¹

Changes in DNA — in our genetic material — can cause cancer. And this is where the challenge lies: since our DNA is unique, every cancer is different.

¹ Source: http://www.webmd.com/cancer/default.htm
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Where medicine is today


The guidelines physicians use when they prescribe medications are general recommendations which are based on analyses of specific patient groups and kinds of cancer. In other words, cancer patients are given treatment that is tailored to the disease itself but not to the individual patient, the exact biology of the tumor or any patient-specific traits. This means that the ideal medicine is not always selected in every case.

In the meantime, research has begun integrating genetic data about individual patients into the process of making decisions about medication. Genetic mutations which cause cancer and are responsible for its growth are the point of departure for exactly this kind of personalized treatment.
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Using MH Guide for customized cancer treatment

Precision


Your tumor sample is sequenced in a special laboratory.

Comparing information


The data obtained from sequencing are compared with the database in the MH Guide product.

Findings of the analysis


Your treating physician receives a medical report from the MH Guide-certified physician which serves as the basis for a personalized therapeutic decision.

The MH Guide software is a medical device registered throughout Europe. It offers your oncologist a unique form of support in finding the right medication for „your“ cancer — medicine that is effective and has as few side effects as possible.

Which patients are good candidates for a MH Guide analysis?

As a rule, all solid tumors can be analyzed. The tumor specimen has to meet particular criteria in terms of its quantity and quality. Analyses tend to be especially interesting for patients who have exhausted standard therapies because their disease has reached an advanced stage or because they may benefit from participating in an appropriate clinical trial. A number of different substances are currently being tested in clinical trials to determine their efficacy.

Answers to other frequently asked questions can be found here

How you can benefit from an analysis with MH Guide:

You will receive:

precise individual treatment options for your personal situation

the direct path to a more effective drug-based cancer treatment with fewer side effects — from the very beginning

access to the latest medical developments

information about any clinical trials that may be relevant for you

The step-by-step procedure for receiving customized cancer treatment

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The consultation between the physician and patient
Your treating physician will talk to you about the option of an MH Guide analysis in your particular case.

Your oncologist will contact our MH Guide-certified physician
After this consultation with your treating physician, he or she will contact an MH Guide-certified physician. They will resolve any open questions and discuss the next steps in preparing the analysis.

Preparing the analysis
Your doctor receives all of the relevant information and forms needed to prepare the analysis.

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Order
The MH Guide-certified physician works with the treating physician to arrange the necessary tissue samples. The samples are then further processed and analyzed to obtain data.

Findings
After the genetic examination of the samples (the DNA sequencing) and subsequent analysis by MH Guide, a medical report is issued based on the findings. This report is created by a MH Guide-certified physician who will communicate the findings to your treating physician to support him or her in selecting customized treatment.

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The consultation between the physician and patient
Your treating physician will discuss the findings and therapeutic options with you as well as talking about potentially enrolling in a suitable clinical trial.

Who pays for the costs of a MH Guide analysis?

As a rule, having an MH Guide analysis conducted is (still) considered an out-of-pocket expense, and in most cases you will have to cover the costs yourself. Please contact us for more information: CustomerCareEU@molecularhealth.com

MH Guide certified physicians and laboratories in Germany

Would you like us to conciliate between your treating physician and an MH Guide certified physician? Please contact us:

Mr.Mrs.
I agree that my name, email address, and any other information I provide, can be transferred to Molecular Health GmbH and processed there for the purpose of answering my request. I have read the privacy policy and hereby agree that my personal data may be processed as described. I can revoke this agreement at any time.

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Protecting your personal data is a critical issue in our eyes

MH Guide is registered in Europe as an in-vitro diagnostic medical device, which means it is subject to strict monitoring and regulation. MH Guide works only with pseudonymized data: we learn only the sex, age and ethnicity of the patient. No other personal identifying information is communicated or saved. Only the treating physician and the MH Guide-certified physician have access to any other personal identifying information.

Both in Germany and throughout Europe, Molecular Health products have met the standards of the German Genetic Diagnostic Act (GenDG) and the Federal Data Protection Act (BDSG). More on quality and safety can be found here.

FAQs

Which kinds of cancer can be analyzed with the MH Guide?

Molecular Health Guide® (MH Guide) can be used to analyze every kind of cancer that has solid tumors, i.e. not leukemia. Analyses with MH Guide are considered especially useful for patients with rare forms of cancer as well as cases in which the cancer has metastasized (spread to other organs) or in which previous treatment regimens had limited or no success.

How long does the analysis take?

The entire processing period takes around four weeks for sequencing both the genetic panel (approximately 600 genes) and whole exome sequencing (approximately 20,000 genes). This covers the entire period from when the sample arrives at the laboratory to the time when the report is sent to the treating physician, and it includes genome sequencing, data processing, and generating the report.

What kind of information does the genetic analysis provide?

Molecular Health Guide® (MH Guide) provides information about the presence or absence of certain mutations in the patient’s tumor or the control sample. Furthermore, potentially relevant clinical and scientific data as well as information about the reliability of the findings are made available for physicians to include in their assessment.

The data about the mutations that have been identified do not lead to clear-cut clinically actionable findings in every case, since genetic changes cannot always be directly linked to a potentially effective therapeutic option. For example, there may not be clear-cut information if there is not enough clinical evidence of a mutation or if the reliability of the findings is not robust enough due to quality problems with the sample.

As a rule, the process of analyzing the genetic variants in a tumor has shown to be a valid approach to gaining more insight into the nature of an individual patient’s cancer. This helps the specially trained physicians and treating physicians make therapeutic decisions with greater precision. MH Guide provides access to high-quality biomedical reference data in great depth so that our specially trained doctors have an optimal foundation of evidence for clinically interpreting mutations in cancer patients.

What are incidental findings, and how are they handled?

In the course of analyzing genetic data via Molecular Health Guide® (MH Guide), the physicians may discover information about genetic changes which are not directly related to the cancer diagnosis that was the reason for the analysis, but the information may nevertheless be of medical relevance to you and your family. This kind of additional information is known as incidental findings. The physicians who work with MH Guide are not actively looking for such findings. If, however, they come across something that indicates a preventable or curable disease, they can communicate this information to a genetic specialist if you wish.

Any incidental findings involving genetic diseases that are not relevant to your cancer can be discussed in a consultation with the genetic specialist. In the informed-consent declaration, you can indicate whether you wish to be informed about any such findings.

What does Molecular Health use the tissue samples for?

Molecular Health uses your samples for the genetic analysis of your tissue specimens. Furthermore, if you have given your consent, they may also be used for quality-control purposes.

The right to withdraw consent and to remain uninformed

You have the right to refuse a genetic analysis from the outset. Once a genetic examination has begun, you still have the right to remain uninformed about some or all of the results, or even to have all of the related information deleted. You can contact your physician to withdraw your consent to the analysis at any time, verbally (by telephone) or in writing, and do not need to provide any further reasons. You have the right not to be informed about the results of the analysis (the right not to know). In addition, you also have the right to stop the ongoing examination process at any time up until the results are communicated to you, and to demand the destruction of materials as well as of results which are have already been obtained at that point in time. Please note that subsequent inquiries about the findings will then be no longer possible.

Do patients have to undergo a medical procedure to provide a tissue sample?

When a Molecular Health Guide® (MH Guide) analysis is ordered, histological and other routine diagnostic information about your disease should already have been collected. For most patients, enough of a tumor sample has already been taken and stored, and it is thus available without any further medical intervention at the time of the MH Guide analysis. Should additional material or blood samples be required for the analysis, your physician will speak to you about it and inform you of any possible related health risks.

Are there risks related to genetic data?

Genetic data can contain information about whether you have an inherited predisposition to certain diseases. This can also affect your family members and confront you with a new situation.

Furthermore, there is a very slight chance of identifying someone by their genetic characteristics, but this risk is very low. This risk only exists in the unlikely event that the patient published their own genetic data online at an earlier time (e.g. for genealogy purposes) and that an unforeseen data breach accidentally made Molecular Health information available to a third party. The security measures implemented for MH Guide comply with the state of the art and are designed to rule out the misuse of data. Any misuse of patient data is a punishable crime.

How is confidentiality guaranteed?

Both the MH-Guide-certified physician and treating physician are bound by medical confidentiality, although they may communicate with each other. This is necessary so that they can discuss the indication and stage of the illness, co-medication as well as any clinical information necessary for the ideal therapeutic decision.

Do I have to give informed consent before the genetic analysis is conducted?

The law states that you have to give your consent before a procedure is performed. This ensures that you were given enough information about the procedure and understand what it involves. By signing the document, you confirm this and agree to have the genetic analysis conducted.

If you can not find the answer to your question, please contact us

Explanations of medical and technical terms

annotation

The process of linking information about sequencing to information about those genes.

biomarker

A substance or biological characteristic in the tumor tissue, blood or other bodily fluid that can be identified via test procedures and used to diagnose or monitor cancer or assess the response to treatment.

carcinoma

A malignant tumor of the epithelium (skin tissue or lining of an organ).

clinical trials

Also called clinical studies. Clinical research conducts carefully structured tests to determine the safety and efficacy (=effectiveness) of drugs, medical devices, diagnostic processes and approaches to treatment.

DNA

Deoxyribonucleic acid. A cellular macromolecule that carries genetic information.

DNA sequencing

The process of determining the order of the nucleotides in a DNA molecule.

evidence-based

Supported by a large amount of research that confirms the findings.

gene expression

The process in which genetic information is used to form proteins.

genome

A simple set of a cell’s chromosomes that makes up its genetic material.

genotype

The entirety of a living being’s genetic factors.

IVD

An in-vitro diagnostic (IVD) tool is any medical device which is designed by the manufacturer for use in in-vitro examination of specimens taken from the human body, including blood and tissue samples, and used exclusively or primarily to determine certain information. An IVD can be a reagent, reagent product, calibration material, control material, kit, instrument, apparatus, device or system used alone or combined with other such devices.

maintenance therapy

Usually, after an effective first-line treatment, a pause in therapy is scheduled so the body can regenerate from the effects of the medicines. If, however, the first-line treatment does not have the intended effects — if the tumor has reacted only slightly, if at all, and the symptoms have not improved — the physician can prescribe maintenance therapy. In doing so, the doctor switches to another drug to achieve the same effect (that is, shrinking the tumor). Maintenance therapy begins immediately after first-line treatment with no pause in between.

medical device

Medical devices are products the manufacturer designs for a medical purpose and for human use. Unlike drugs, which have an effect that is pharmacological, immunological or metabolic, medical devices when used as intended usually achieve their effect through a physical route.

next-generation sequencing (NGS)

An approach to high throughput sequencing. This is an optimization of standard sequencing technologies. NGS enables researches to decode major amounts of DNA within a very short time. The most advanced sequencing devices of this generation are able to create corresponding amounts of data within a single sequencing process. This means entire genomes can be decoded quickly.

mutation

A spontaneous or externally created change in genetic material.

off-label use

The use of prescription medications for a purpose other than the one which was officially approved.

oncogene

A gene that can transform a cell into a tumor cell under certain circumstances.

panel analysis

An analysis of the genes that may be relevant in treating cancer. This involves more than 500 genes.

pharmacovigilance

Pharmacovigilance is the process of ongoing and systematic monitoring of a finished medical product’s safety in human or animal use. The objective is to identify any adverse effects, assess them and interpret them so that the appropriate measures can be taken to minimize risk

personalized medicine

Treatments which are customized to the individual needs of patients and based on information taken from different biomarkers.

predictive biomarker

A predictive biomarker makes it possible to estimate how well the patient will respond to a particular treatment, and it assists physicians in selecting the best possible form of therapy.

response rate

The number of patients who react to treatment.

sarcoma

A malignant tumor in connective tissue.

specimen

A (tissue) sample.

first-line / second-line treatment

The different phases of treatment which are administered in a certain order are known as first-line and second-line treatments. In some cases, a period of maintenance therapy takes place between these two phases.

recurrence

Recurrence (from the Latin for “falling back”) is the return of a disease, a psychological disorder or related symptoms after a treatment which was temporarily effective or after spontaneous remission. In the context of cancer treatment, recurrence usually happens because the tumor was not completely removed, and after a certain period, this can cause the disease to come back.
If there has been no recurrence in the five years after treatment, the patient is generally considered to be cured. However, some tumors can cause recurrence much later than that.

UICC staging

A tumor classification system that was created by the Union Internationale Contre le Cancer.

whole-exome analysis

An analysis of all of the transcribed regions of the human genome. It includes over 20,000 genes.