GCLP
SERVICEAs an institution specializing in the analysis of samples used in clinical trials, Macrogen also offers services for identifying bio-markers in addition to regular analyses.
The quality of services offered by Macrogen is controlled to meet the standards of GCLP in Korea as well as global certifications (e.g. CAP, CLIA and CSP). Analysis services are mostly based on multiomics, which means the analysis of the genome, transcriptome, proteome and metabolome, among others.
SERVICE
The ”Clinical Genome Business Unit” of Macrogen provides specialized services in the analysis of samples used in clinical trials. In addition to its designation in 2019 by the Korean Ministry of Food and Drug Safety as Korea’s first ever lab for sample analysis in clinical trials, Macrogen has also acquired GCLP certification in Korea and certifications from the CAP, CLIA and CSP abroad– a testament to the quality services that set the company apart from other players in the market, as well as the its commitment to meeting the requirements of clinical trials both at home and abroad. In addition, Macrogen has gone a step further as a CRO to develop further services such as those for detecting bio-markers. The clinical analysis services offered by Macrogen go beyond simple analysis of the samples and are strategically designed to improve the likelihood of the trial’s success.
ClinPharm Seq
The ”Axen ClinPharm Seq” is an individually tailored genetic test on 59 genes involved in drug metabolism. All drugs carry the risk of side effects. The efficacy of drugs, too, may vary according to the genetic specifics of an individual. Through genetic testing, the Axen ClinPharm Seq helps develop a prescription best tailored to the individual’s needs. The test can also be used in the screening of participants in the clinical trial to verify the safety of new drugs. Each individual participant in a clinical trial carries the risk of potentially severe side effects depending on their genetic makeup. Through better understanding of these individual specifics, better criteria can be set up for the screening of participants in clinical trials, as well as more practical information being made readily available to address medical emergencies due to side effects should they occur during the trials. It is one of the best options to maximize the chances of success in clinical trials while minimizing the risk to the safety of participants.
Total 36 participants died from ADRs last year
from ADRs
| Sorting | 2016 | 2017 | 2018 | 2019 | June 2020 |
|---|---|---|---|---|---|
| Death | 21 | 29 | 31 | 39 | 14 |
| Hospitalization and Other |
288 | 260 | 273 | 264 | 141 |
| Total | 309 | 289 | 304 | 300 | 155 |
Features
With just a single test performed once in your lifetime, ClinPharmSeq allows for tailored treatment of diseases. ClinPharmSeq tests 59 genes closely associated with a range of diseases, thereby increasing the efficacy of treatment drugs while lowering the risk of side effects throughout your life.
ClinPharmSeq is
particularly effective
in any of the following
circumstances.
- There is a huge variance among individuals in the reaction to a drug
- The treatment area is small
- There is a possibility of severe side effects
- There is treatment resistance
- Long-term treatment is required
- The treatment drug is expensive
ClinPharmSeq can be
used to test for
reactions likely to
occur to the following
drugs, among many.
- Anti-viral drugs and anti-fungal drugs used to treat infectious diseases
- Drugs to treat hyperlipidemia in the circulatory system
- Immunomodulatory agents and cytotoxic chemotherapy drugs used to
treat cancer/ autoimmune disorders - Antidepressants used for mental health or to treat behavioral disorders
- Anticoagulants used to treat diseases related to the blood or the
hematopoietic system - Drugs used to treat gout, hormonal disorders or metabolic
syndromes - In addition to the above, ClinPharmSeq can be used for many different kinds of diseases.
Panel Specification
| Panel Specification | |
|---|---|
| Target Site | About 812kbp |
| Regions | Exons + UTRs + 5’ UTR + 3’ UTR |
| the number of genes | 59 |
| Samples | gDNA 500ng |
| Whole Blood 4ml x 2pcs. | |
| Types of Mutations | SNV, InDel, Large Insertion and deletion |
Multi Omics
Multiomics refers to the integrated and comprehensive analysis of a large volume of data generated and collected on the molecular level, such as data regarding the genome, transcriptome, proteome and metabolome.
The emergence of new technologies and equipment has allowed us to identify the correlations between the varied and complex biological units within our body, and grasp a better understanding of the physiological biomarkers for certain diseases and their treatment. Single gene disorders that occur due to a mutation in one gene rarely have an etiological explanation. But comorbidities involve a number of modifier genes and various other factors, making multiomics analysis necessary.
in the tumor and immune microenvironment
and identify biomarkers with potential
therapeutic impact.
localizations in response to infections
disease, allergic inflammation and
autoimmune disorders.
complex neural tissues in response to
disease and traumatic injury.
Features
Applied Area
- Single molecular RNA & Protein
- BioPharma
- Immunology
- Infectious Disease
- Oncology
- Neuroscience
- Spatial Transcriptomics
- Spatial Muliomics
- Cell & Gene Therapy Solutions
Platforms
Technical support with the latest analysis equipment
- Xenium In Situ (10X genomics)
- CosMx (nanostring)
- GeoMX (nanostring)
- Olilk Q100 (Olink)
Storage of samples
Macrogen offers another category of services dedicated to the storage of analytical samples.
- For clients that find it challenging to store samples on site during clinical trials, Macrogen stores the samples for a certain period of time on their behalf.
- Following the completion of clinical trials, retention samples that need to be stored either over the short or long term can also be stored by Macrogen on the client’s behalf.
The entire process of the hand-over to shipping and storage are tracked for temperature control. Data on temperature monitoring are also offered to the client. Samples that are required to be stored at an ultra-low temperature (of -70℃ or lower) are handled with particular care, including real-time monitoring of the temperature and recording of the temperature at regular intervals for safe and reliable storage.
A through back-up system is in place to safeguard the samples should unexpected incidents occur.
- A back-up system using carbon dioxide in case of power outages or equipment breakdowns.
- Text notifications automatically sent to the mobile phone of relevant personnel in case of emergencies.
