Genome-guided treatment decision support for clinical routines From sequencing data to a patient report within minutes MH Guide is analysis software that supports molecular pathologists and oncologists in the interpretation of extensive molecular data sets. MH Guide makes complex NGS data sets readable and automatically identifies relevant genetic variants that are important for the treatment of cancer patients. This information is translated into concrete clinical knowledge: • Which targeted or immuno-oncological therapies are promising for this individual genetic tumor profile?
• What therapies pose a safety risk? • Are there ongoing clinical studies for which this patient is eligible? MH Guide summarizes this information in an intuitive analysis report. For this purpose, the software places the genetic data in the context of the most current scientific knowledge from one of the largest learning databases in the world, Dataome.
The most important features at a glance MH Guide is approved as an IVD medical device in the EU and is intended for diagnostic use. a Non-small-cell lung carcinom Diagnosis — ICD-10-CM code ll-Cell Lung) D002289 (Carcinoma, Non-Sma MeSH ID/term Additional MeSH IDs —
Patient ID SP0006-GOLD SP0006-GOLD Case ID Date of birth 01 Jan 1963
CORRECTED REPORT Sex Ethnicity Country Trial ZIP code
Male — US 77007
Collected Tumor cellularity
Lung S-13-008808 — no
Primary tumor site Surgical pathology Tissue type Metastatic
Barcode Sample type Labtest
• Molecular pathologists, laboratory diagnosticians, and oncologists use MH Guide to automatically analyze NGS data and provide treating physicians with an intuitive report of results for their cancer patients.
9264 General dataset ID 10065901
Software version
464
89897177 CVI dataset ID Organizational unit MTSINAI
INTERPRETATION
patient disease ly mutated genes in the Mutational status of common KRAS ERBB2 EGFR BRAF ALK not ABCB1 not 2 SNV 2 fusion, 1 not not identified identified identified identified SNV ROS1 not identified
TP53 not identified
STK11 not identified
r profile and on evidence
Based on the patient's molecula tion
Test Comment - Interpreta
3 Ineffective
Potential impact Effective
Effective
Effective
Treatment
Drug approval
Gefitinib
Approved
Pembrolizuma b
PIK3CA not identified
Biomarker
VAF
ALK/EML4 (fusion)
—
TMB-H 20.00 mut/Mb (TMB)
—
MSI-H (MSI)
—
CD274 Overexpression (protein expression)
—
RET not identified
the preferred treatment
diagnostic findings
3 Diagnostic
0 Prognostic
14 Safety
NRAS not identified
should be considered as
Overview of prognostic and
t impacts
13 Effective
NF1 not identified
MET 1 SNV
from publications, Gefitinib
SUMMARY Overview of potential treatmen
Ordering Dr. Mary Doe physician — Facility us@molecularhealth.com Email +1 617 718 5863 Phone MH Panel V1 Fax (unpaired) (pre MH Product MH Guide Guide 4.1.0) MH Guide Premium Report 4.2.2
28 Mar 2017 75% A00254 FFPE
Biomarker score
option for the patient.
Clinical trials found 19
Trials
Trials
The MH Guide report includes: • Information on relevant genetic alterations and biomarkers • Overview of potential treatment options based on identified biomarkers • Information on evidence and guideline anchoring within the indication • Information on potential drug resistance and adverse drug effects
2
• Listing of relevant recruiting clinical trials 2
Approved
CD274 Overexpression (protein expression)
Approved
Durvalumab
2
—
Phone — Order date 11 Apr 2017 Report Version 3
Molecular Health GmbH,
Signed by 10 Sep 2020 10:23 (UTC+02:00)
Kurfuersten-Anlage 21, 69115
Page 1 of 41
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Fact sheet MH Guide
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