METHODOLOGY

MH Guide® – highly effective solution for annotations, markers and more

Methodology
LAB

Research
Clinical profiling as a standard in
personalized cancer treatment - a challenge for cancer

 

The patient makes decision to undergo the study on his own.

INDICATIONS

The information contained in the MH Guide® report can be requested (taken in consideration) by a medical oncologist to support clinical decision-making in determining the strategies and tactics of potentially effective and safe treatment

The targeted choice of personalized treatment of solid malignant tumors of any location.

Confirmation of planned therapy in the context of the genomic profile of the tumor.

Identification of additional approaches to the treatment of rare or advanced forms of cancer

Prediction and assessment of toxicity, side effects, safety of anticancer drugs.

Information about clinical trials of drugs related to the disease.

COLLECTION AND TRANSPORTATION OF BIOLOGICAL MATERIAL

For the test, the patient should go to a medical facility, which has a special agreement with ONCOGENE®.

The patient should bring his sample of the tumor in paraffin, previously obtained by biopsy or surgery and give blood from the vein. Medical facilities, in which patients can give their biological material, are listed here

CONSENT, AGREEMENT, PAYMENT

Methodology

Before delivery of the biological material for genetic research, the patient gives informed consent, which is integral part of the agreement with ONCOGENE®. Payment can be made in different ways (bank transfer or cash).

GENOMIC PROFILING

Methodology

Genomic profiling of tumor samples and blood of the patient is done in a genetic laboratory of the company Centogene AG (Germany), having all kinds of international, industry certifications and accreditations (CLIA, CAP, US LLC NPI, ISO 15189, GMP, GLP, Illumina Certification).

Genomic profiling process includes DNA isolation from the tumor sample and blood of the patient (control), and whole-exome (>20 000 gene) sequencing (Whole Exome Next Generation Sequencing).

Sequencing is performed on the certified equipment and reagents Illumina according to the requirements of the software developer MH Guide® (in particular, with a covering of at least 200).

ANALYSIS OF THE GENOMIC PROFILE

Methodology

Patient’s genomic data as a data file FASTQ or BAM are loaded through secure access in MH Guide® – proprietary software, designed for bioinformatics analysis and interpretation of genomic profile of solid malignant tumors.
MH Guide® is associated with Dataome® – the world’s largest cloud technology platform (proprietary knowledge base), intended for collection, processing, integration and analysis of the structured and unstructured world medical, biological and pharmacological data with the highest quality, amount, diversities, novelty, relevance, safety and utility in real time. The platform Dataome® reflects the current state of the world's most accessible biomedical knowledge about more than 6 000 000 disease cases The knowledge database Dataome® contains biomedical data from 26 millions of scientific and medical publications, as well as data on 273 000 drug interactions, 7 000 biomarkers of efficiency and drug safety, 85 000 gene variants, 56 000 drugs, 126 000 clinical trials, 270 000 protein interactions, drug safety information of 9 million of patients and more.

DATAOME®

MEDICAL
REPORT

Patient’s genomic data are compared with the latest published, proven and reviewed world's biomedical knowledge from Dataome®, as a result an interactive report is generated, the content of which is verified and validated by certified specialists on molecular pathology and oncologists with experience in the area of precision medicine. Certified physician is a responsible health care professional according to the German gene diagnostics act (GenDG).

Medical report MH Guide® comprises

1
The description of clinically detectable significant mutations in the context of the patient's disease.
2
Potentially significant information about clinical and scientific research of the detected mutations.
3
Potentially effective and ineffective drugs, based on analysis of the detected mutations of patient's tumor.
4
Drugs with potential side effects based on analysis of the pharmacogenomics markers.
5
Other relevant information from external databases: COSMIC (Catalogue of Somatic Mutations in Cancer); dbSNP (Single Nucleotide Polymorphism Database); NCCN (National Comprehensive Cancer Network); Drug Label Information.

INDIVIDUAL TREATMENT STRATEGY

Methodology

The patient provides a report of MH Guide® to his oncologist for the decision support when defining a strategy of potentially effective and safe treatment. The report can be extended and supplemented by the medical oncologist based on his own experience.
MH Guide is registered in Europe as a medical device (IVD) for tumor analysis and annotations of options. This means, that we are under strict control and regulation in accordance with German law.
No personal information will be shared. Only the attending physician and the certified physician have access to the personal data of patients. Molecular Health works only with anonymized data; we just need the gender, age and ethnicity. No personal information is shared or stored.