As 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.
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.
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.
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.
in any of the following
ClinPharmSeq can be
used to test for
reactions likely to
occur to the following
drugs, among many.
|Target Site||About 812kbp|
|Regions||Exons + UTRs + 5’ UTR + 3’ UTR|
|the number of genes||59|
|Whole Blood 4ml x 2pcs.|
|Types of Mutations||SNV, InDel, Large Insertion and deletion|
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.
Technical support with the latest analysis equipment
Storage of samples
Macrogen offers another category of services dedicated to the storage of analytical samples.
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.