Patients | Molecular Health

Patients

Every patient and cancer are unique – and your medication should be unique, too.

How you can work with your oncologist and the Molecular Health Guide (MH Guide) software to identify the best medication for you.

Patients

Every patient and cancer are unique – and your medication should be unique, too.

How you can work with your oncologist and the Molecular Health Guide (MH Guide) software to identify the best medication for you.

What you can do today

Medical guidelines for cancer recommend you should analyze your tumor cells as soon as you are diagnosed to find out the genetic variants that point to the best drug for fighting your cancer. Currently, the majority of cancer patients are treated using traditional platinum-based medicine (chemotherapy for general cell growth inhibition), risking unwanted side effects and with an unclear tumor response.

 

 In order to find the best drug from the different types such as chemotherapy, targeted drugs,  or immunotherapy, the DNA of your tumor cells must be analyzed using next-generation sequencing (NGS) and MH Guide to detect and interpret all of the disease-relevant genetic variants for the best matching medication.

 

Read more about this in our Medical information section about specific cancer diseases and how your treating physician can find the best medication for you.

Chemotherapy, targeted, or immunotherapy?

 

Cancer is an abnormal growth of defective cells. Cancer cells divide uncontrollably, compared to healthy cells. They create a mass of mutated cells with many genetic variants from up to 400 clinically relevant genes (this is called the molecular profile).  Chemotherapy works on your whole body and might cure cancer, although for 20% of all patients, it will not have the desired effect. Targeted medicine is designed to target and fight against an individual molecular profile and stop those cells from growing. Immunotherapy uses our understanding of cancer growth processes to mobilize the immune system to attack cancer cells. 

 

There are many different targeted and immuno-medications available and also running medical trials for new medications that you might want to join.

 

Read more about this in our Medical information section about specific cancer diseases and how your treating physician can find the best medication for you.

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Using MH Guide for effective cancer treatment

The MH Guide software offers your oncologist a unique form of support in finding the right medication for “your” cancer — that is effective and has as few side effects as possible. Read the MH Guide report to understand how. (link to report)

 

From the biopsy to the report it may take up to 20 days – you need to be patient to wait for the right information to choose the right medication with your physician.

 

For colon cancer (CRC), breast and ovarian cancer (BOC), and endometrial cancer, it might be suitable to use MH Mendel or MH BRCA in addition, to identify the phenotype (hereditary cancer) before starting any medication therapy.   

Your tumor sample is taken from a biopsy or resection and the tumor DNA/RNA is sequenced in a specialized NGS laboratory using a specific assay (test kit) to check a certain list of genes.  Since the number of genes known to have an influence on medication is growing, we recommend a gene panel that looks at least 500 genes, or a whole exome (WE) assay with 20,000 genes. There are other non-NGS tests (e.g., protein expression) that might be added to the tumor study, e.g., to make a decision towards an immunotherapy.

 

Your benefit: your physicians have a frozen sample of your tumor for various diagnostic tests

The raw data obtained from sequencing are used for variant detection and are analyzed and compared with the latest medical developments stored in the biomedical, drug, and phenotype database in MH Guide (800 million variants, 4600 phenotypes, 5000 clinically actionable cancer variants, 300 cancer drugs, n clinical trials).

 

Your benefit: the decision for medication is based on the latest medical knowledge

 

 

 

 

 

Your treating physician or human geneticist receives a medical report from the MH Guide-certified physician. This serves as the basis for a personalized medication plan, including a list of relevant trials, or a hereditary predisposition diagnosis.

 

Your benefit: you see which treatments or clinical trials match the variants detected in your cancer cells

 

 

 

 

 

 

Which patients are candidates for an MH Guide analysis?

In general, all cancer diseases (solid tumors and blood cancers) can be analyzed. The tumor sample must meet specific criteria in terms of its quantity and quality. So, the first step is the “right” sample (biopsy or resection) and sample preparation, the next step is choosing the right, comprehensive lab assay, and the MH Guide can analyzes all the relevant cancer data and creates an intuitive report that includes a clear recommendation for the best medication. 

Read more about this in our Medical information section about specific cancer diseases and how your treating physician can find the best medication for you.

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 medication 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

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How you can benefit from an analysis with MH Guide

You will receive:

Precise individual medication options for your personal situation

Molecular Health Button

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

Molecular Health Button
Access to the latest medical developments  
Molecular Health Button

Information about any clinical trials that may be relevant for you

 

Molecular Health Button

Who pays for an MH Guide analysis?

Depending on country-specific regulations and on the cancer disease, an MH Guide analysis and the underlying NGS assay is reimbursed. Reimbursement is either a standard or initiated per additional extra request. You can use our know-how to formulate a reimbursement request with a high likelihood of success. If the NGS assay and the MH Guide analysis are not reimbursed in your case, you may want to cover the costs by yourself.

 

Medication that is approved for your disease is typically reimbursed. Medication that is off-label for your disease is typically not reimbursed. You might consider joining a trial for a new medication to take advantage of financial support from the pharmaceutical company developing the new drug. All of this information is available on the MH Guide report.

 

Our team is ready to answer all your questions: CustomerCareUS@molecularhealth.com 

Protecting your personal data is a critical issue in our eyes
Both self-paying and reimbursed patients or those whose employers offer the Corporate Oncology Program for Employees (COPE) can rest assured that none of their personal information is communicated to the company. Only the treating physician and the MH certified physician have access to personally identifying patient data. Molecular Health works exclusively with pseudonymized data; no personal information is conveyed or saved.
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Explanations of medical and technical terms

Gene annotation is the process of identifying the gene variants in a person’s DNA. Variant annotation is an explanation of changes in specific genes. Scientists and Physicians use them as an important information  for the  right medication for all genetic diseases, especially cancer.

  • A predictive biomarker is describing either a effective, ineffective or toxic biomarker (a gene variant in combination with a specific medication and its effect)
  • A diagnostic biomarker is describing a gene variant in combination with a disease (for disease determination) or disease predisposition
  • A prognostic biomarker is describing a gene variant in combination with the prognosis (e.g. progression free survival)

A cancer in the skin or in the tissue lining internal organs. This is the most common type of cancer.

A clinical trial is a research investigation where the response of patients to a medication is monitored to find out about the drug’s safety and efficacy, to see if it cures a disease or causes unwanted side effects. Patients take part in trials on a voluntary basis. The advantages of a trial for a patient can include access to a new medication, no costs for a medication and a high level of attention.

DNA is short for Deoxyribo Nucleic Acid. This is the name for the molecules that carry the genetic information that defines how organisms develop. Children inherit DNA from their parents. DNA is short for Deoxyribo Nucleic Acid. This is the name for the molecules that carry the genetic information that defines how organisms develop. Children inherit DNA from their parents.

DNA is genetic information made up of the building blocks A, C, G, and T arranged in the well-known double helix structure. DNA sequencing is done in a lab and tells scientists which order these chemical building blocks come in. If the order of these blocks change, this is called genetic variant. This information is used for diagnosing diseases and finding the best treatment.

A decision is evidence-based when it is made based on objective scientific information that proves that the chosen strategy is better than the alternatives. It is typically derived from parameters like the size of a patient group in controlled trials or other parameters.

When the information in DNA is converted into instructions for making proteins and cell structures, this is called gene expression. If a gene is expressed at a higher level than usual, cancer can be the result. Gene expression can be measured by testing RNA or proteins.

This is a medical test that looks for changes in a person’s genes, called variants. The results can confirm a disease diagnosis or find a treatment that has been proven to be effective against diseases caused by genetic changes.

Genetic tests for cancer are done in labs using a sample that can be a biopsy taken from a tumor, or a blood sample.

Genetic tests are voluntary. They are reimbursed in certain cases.

A genome is the complete set of genetic information of an organism. The cancer genome is the genetic information in cancer cells.


The Whole Genome (WG) is the complete genetic information in an individual and is composed of exonic and intronic regions.


The Whole Exome (WE) is describing all exonic parts of the gene that are coding the proteins from the gene.


Cancer is the result of changes (variants) in the DNA sequence of the exonic regions of genes of the cancer cells.

The complete, unique sequence of genes in your DNA, inherited from your parents.

A germline variant is a DNA change that has been inherited from a parent. It passes from an egg cell or a sperm cell into every cell of the body. Germline variants define a person’s characteristics, from eye color to a predisposition of disease.

 

Cancer caused by a germline variant is called inherited cancer. Up to 20% of all cancers are inherited where the most known hereditary cancers are Breast & Ovarian Cancer and Colon Cancer.  

IVD stands for In Vitro Diagnostic and it indicates a tool made for diagnosing diseases. IVDs used in oncology include, for example, genetic tests or software for analyzing variants. Tools that are certified IVDs have passed strict quality-controls.

A maintenance therapy starts after the first-line therapy with the goal of slowing the cancer’s growth. It can be a medication used for hormonal therapy, chemotherapy, a targeted or immunotherapy. For example, if a cancer goes into remission after the primary therapy, the physician may prescribe a maintenance therapy to help stop it coming back.

Tools made to be used for testing, diagnosing, or treating diseases. Medical devices are subject to quality checks at all stages of their development. Medical devices used with cancer patients include genetic tests, monitoring software, imaging machines, and devices used in surgery. Medication and Drugs are not medical devices, they are subject to separate rules.

Next-Generation Sequencing describes tests performed one on a cancer sample that can identify variants in the gene sequence that are important for understanding a disease and finding the best medication. Because these tests have become very fast compared to tests done in the past, they are called “next generation.”

Also called a variant or an alteration, a mutation is a permanent change of a gene in the DNA sequence. Mutations are either inherited or they can occur during a lifetime. Mutations are usually harmless, but they can also lead to the formation of tumors.

Off-label drug use is when an approved drug is used for an unapproved disease. It is common in cancer medication because cancer drugs can be effective for many cancer diseases. Reimbursement may be more complicated for off-label drugs; patients may have to pay for the drug themselves.

This is when a subset of genes, called a gene panel, is analyzed to find genetic evidence of disease or information about the best medication. The testing technique is called next-generation sequencing. Studying a gene panel, rather than the whole exome or whole genome, allows scientists to look at the genes known to be important for cancer diagnosis or medication in greater detail.

In personalized medicine, physicians look at the unique genetic make-up of a person to diagnose a disease that is already active, or to predict the person’s susceptibilty to a disease in the future. Personalized medicine also helps physicians to choose a medication that is effective against a genetic change causing a disease, or to avoid a medication that will cause predictable side effects. A genetic test is a prerequisite for personalized medicine.

Pharmacovigilance is another word for drug safety. After a drug is approved, medical authorities continue to monitor that it is safe. If the drug causes side effects, these are tracked and normally published e.g. on the drug label.

This describes a person’s currently observable physical characteristics, both how they look (height, hair color) and how they feel (mood, health). Your phenotype is affected by your genes and your environment.

 

“Phenotype” can also be used to describe a group of characteristics, for example, a disease or condition. Some phenotypes are known to be linked to genetic variants, for example, some hereditary breast and ovarian cancers are known to be linked to variants on the BRCA1 and BRCA2 genes.

The response rate is the percentage of patients whose cancer shrinks because of the medication they take.

A cancer that begins in the bone or in the soft tissues such as muscles, or fat, or connecting tissue. The type of cancer depends on where it starts. For example, if the cancer starts in the bone it is called osteosarcoma, if it starts in fatty tissue it is called liposarcoma.

A somatic variant is a DNA change that happens to a person’s genes during their lifetime. The change can be caused by damage to genes due to smoking or exposure to the sun or – which is the most frequent case – just by chanced. It may cause disease or be harmless. Cancer Cells and its growth is associated with somatic variants. Somatic variants to not define a person’s characteristics.

The first-line treatment (also known as primary treatment or primary therapy) is the first treatment or combination of treatments given for a disease. If the therapy is then changed, the next treatment prescribed is called the second-line treatment. For cancer, this could be, for example, surgery followed by a medication.

This is when a disease comes back after a period of time during which it could not be detected.

A tumor classification system that was created by the Union Internationale Contre le Cancer. It measures T, the primary site; N, whether the lymph nodes are involved; and M, the presence and extent of metastatic spread. The physician determines the cancer stage when the cancer is diagnosed.

Changes in the patterns in the nucleotides our genes are made of are called variants. Humans share 99.5% of all DNA, the 0.5% that differs between individuals is responsible for all the diversity in how we look and develop, and also how healthy we are.

 

The pattern changes can be single exchanges (SNVs, also called SNPs), added nucleotides (insertions), missing nucleotides (deletions), or changes in the structure of sections of nucleotides (these can be fusions, or CNAs or CNVs).

A whole exome analysis (WEA) is a genetic test that looks at all the exons in a person’s genome. The exome is around 1% of a person’s genome, which is the entirety of a person’s genes. Most variants that cause diseases are in the exons.

FAQs

Molecular Health Guide (MH Guide) can be used to analyze every kind of cancer, i.e. solid tumors and hematologic malignancies, such as leukemia or lymphoma.

Molecular Health Guide (MH Guide) provides key information about the presence or absence of gene variants (mutation) in the patient’s tumor or the control sample and associate it with the right medicine to stop tumor growth or to show toxic effects of a medication.  The information comes with real evidence from many sources and is clinically validated.

The entire processing period takes around three weeks from the time of the biopsy to the final report. 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.  The longest time is spent in the laboratory for sequencing and sample handling. Molecular Health is continuously striving to improve a lot of these workflow steps in order to shorten this total turnaround time for the sake of the patient.

Talk to your treating physician. He might want to refer you to an oncologist who is trained in molecular oncology/biology. In Europe, molecular oncologists – trained for MH Guide – are called Certified Physicians.  A targeted therapy or an Immunotherapy shall never be started without consulting a molecular oncologist. The oncologist will then organize the next steps. 

Talk to your treating physician. He will know the country specific regulations. The diagnosis (between 2.000 and 5.000 US Dollar) including the use of Molecular Health Guide is reimbursed under certain conditions. The same is true for the targeted or immuno medication but prices can go up to more than 150.000 US Dollar for a yearly treatment depending on the best matching medication.

Molecular Health is not operating an own laboratory but have partnerships with many NGS laboratories around the world. Those laboratories are connected with hospitals using our MH Order Portal. Some bigger clinics run their own laboratory.

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.

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 extremely 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) including personal data that fall under ePHI and that an unforeseen data breach accidentally made Molecular Health information available to a third party including a back linking – comparing two genetic profiles – to the personal data.

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.

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.

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 related document, you confirm this and agree to have the genetic analysis conducted.

Let’s talk about how our technology can work for you

To find out more, you can call our customer service or send us an e-mail. We would be delighted to provide you with more information or answer your questions.

E-mail: CustomerCareUS@molecularhealth.com