CYP2C19 Genotype

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PackagingCharacterization ProvidedSafety, Handling, and Storage

 

They are prepared from individual donors characterized for various CYP2C19 alleles corresponding to high activity, moderate activity and no activity.

Enzymatic activities of CYP2C19 vary significantly among ethnic populations, making it highly important for pharmaceutical studies. CYP2C19 is known to metabolize omeprazole, lansoprozole, propranolol, imipramine, mephenytoin, chloroguanide, hexabarbitone and diazepam. CYP2C19 polymorphisms that result in low CYP2C19 activity increase the risk of adverse reactions to some drugs.

The most common variants are CYP2C19*2 (681 G>A) and CYP2C19*3 (636G>A) (Scordo et al. 2004). CYP2C19*2 has a frequency as low as 0.091 in Caucasians and as high as 0.40 in some Asian populations; CYP2C19*3 is common only in Asian populations. CYP2C19*2 or CYP2C19*3 contribute to the majority of poor-metabolizer phenotypes in Caucasians and Asians but CYP2C19*4 and CYP2C19*5 also lack enzymatic activity. Phenotypically, poor metabolizers occur in 13 – 23% of Asian populations and 2 – 5% of Caucasian populations.

Detailed descriptions of the nucleotide changes characterizing individual alleles and their effects on protein expression and the CYP2C9 phenotype can be found at www.cypalleles.ki.se.

CYP2C19 Allele Frequency

Allele	African American	Asian	Caucasian	Hispanic
CYP2C19*1	0.75– 0.87	0.540 – 0.70	0.83 – 0.909	---
CYP2C19*2	0.10 – 0.25	0.20 – 0.40	0.091 – 0.161	---
CYP2C19*3	0.0 – 0.02	0.0 – 0.14	0.0 – 0.04	---
CYP2C19*4	ND	0.0 – 0.05	0.0 – 0.011	---
CYP2C19*5	ND	0.0 – 0.0025	ND	---

--- = No Data Available
ND = Not detected

Adapted from Xiao, et. al, 1997, Hamdy, et. al, 2002, Allabi, et. al, 2003, Melis, et. al, 2006, Tassaneeyakul, et. al, 2006, Rosemary and Adithan, 2007 and Zandvliet, et. al, 2007.

Packaging

Concentration: 20 mg/mL
Suspension buffer: 250 mM sucrose

Characterization Provided

• Genotype for CYP2C19
• Specific content of cytochrome P450
• Specific content of cytochrome b5
• NADPH-cytochrome c reductase activity
• CYP1A2 Phenacetin O-dealkylation
• CYP2A6 Coumarin 7-hydroxylation
• CYP2B6 Bupropion hydroxylation
• CYP2C8 Amodiaquine N-dealkylation
• CYP2C9 Diclofenac 4´-hydroxylation
• CYP2C19 S-Mephenytoin 4´-hydroxylation
• CYP2D6 Dextromethorphan O-demethylation
• CYP2E1 Chlorzoxazone 6-hydroxylation
• CYP3A4/5 Testosterone 6β-hydroxylation
• CYP3A4/5 Midazolam 1´-hydroxylation
• CYP4A11 Lauric acid 12-hydroxylation
• Donor information (age, ethnicity, gender, cause of death and infectious disease status)

Safety, Handling, and Storage

Informed Consent Statement

A single organization regulates and oversees the use of human tissue intended for transplantation in the United States, namely the United Network for Organ Sharing (UNOS). Organ donors may elect to have their organs used either for transplantation only, or for transplantation or research. Thus, the donor (or the donor's family) has the right to prevent the use of the donor's organs for research. Regardless of the use of donated organs, no compensation is given to the donor’s family; any such compensation is illegal in the United States. In those cases where donors (or family members) elect to withhold organs from research uses, any organs that cannot be transplanted are discarded.

XenoTech receives hepatic, renal, intestinal, pulmonary, and other human tissue from various regional organ procurement organizations (OPOs) that obtain organs approved for research use. Regulations in the United States require that, regardless whether the organ is intended for transplantation or research purposes, the organ donor's identity be treated as highly confidential information. Organ procurement organizations maintain the informed consent records from each donor, and our Standard Operating Procedure requires that XenoTech personnel confirm the existence of informed consent for research purposes, prior to transport of organs to XenoTech. This procedure is intended to ensure that XenoTech manufactures human-derived products only when informed consent has been granted for research use of those specific organs. XenoTech does not, and, in consideration of confidentiality, cannot obtain the informed consent records from these organizations.

All human tissue accepted by XenoTech has been tested for the possible presence of various infectious diseases, and XenoTech does not accept human-derived material unless the donor has tested negative (non-reactive) for RPR, HIVAb, HTLVAb, HBsAg and HCVAb. All human tissue is also tested for CMVAb.  However, due to the widespread (nearly ubiquitous) appearance of CMV in the population, and its relative insignificance as an infectious agent, tissues from donors reactive for CMVAb are accepted.  The serology status of each donor is typically determined by ELISA by the organ procurement hospital.

XenoTech does not deal directly with - nor does it make any direct payments to - the surgeons who procure organs or the medical institutions where they work.

Caution

In the case of human tissue, XenoTech accepts only non-transplantable tissue from donors who test negative for HIV 1 and 2, HTLV, and Hepatitis B and C. However, as a precaution, all human-de­rived samples should be regarded as a potential bio­hazard and should be stored, handled and discarded accordingly. Cellular and subcellular fractions are intended for in vitro use only.

Products

Product #	Name	Amount
H2C19.HA	CYP2C19 High Activity (*1/*1)	0.5 mL at 20 mg/mL
H2C19.MA	CYP2C19 Moderate Activity (*1/*2, *1/*3, *1/*4, *1/*5)	0.5 mL at 20 mg/mL
H2C19.NA	CYP2C19 No Activity (*2/*2, *2/*3, etc.)	0.5 mL at 20 mg/mL