PharmacoCheck+
Allows Clinicians to better understand how their patients will respond to certain medications.
Simple Buccal Swab-FDA
Pharmacogenetics testing stands as a crucial asset in preventing ADRs (adverse drug reactions). These tests examine genetic information to anticipate an individual's response to particular medications.
This approach enables more tailored medication plans, minimizes risks associated with trial-and-error prescriptions, and ultimately reduces costs for both patients and healthcare providers.
Identify which drug may be most effective before treatment starts
PharmacoCheck+ can help clinicians choose the most effective drug for each patient, minimize the risk of adverse reactions, and reduce hospitalizations
Reduce the risk of adverse events related to certain drugs
PharmacoCheck+ can assess a patient’s risk for adverse drug reactions before they take the medication which can improve patient safety and enhance medication management.
Adjust and optimize the dose of current medications
PharmacoCheck+ can help clinicians predict the appropriate dose of medication for their patients. this allows them to create more personalized medication plans to maximize efficacy and reduce Pharmacy costs.
Improve patient care
PharmacoCheck+ results become part of a patient’s medical record, allowing physicians to make more informed decisions when prescribing medications for future medical issues.
PharmacoCheck+ can reveal if a person is a fast, Normal, or slow metabolizer. A person’s metabolism changes the way their body responds to medication, Including:
Toxicity
Excessive amounts of the drug accumulate in the bloodstream, resulting in ADRs.
Lack of efficacy
The bloodstream cannot absorb enough of the drug to achieve a therapeutic effect.
Hypersensitivity
Normal amounts of the drug enter the bloodstream, but even this is enough to trigger severe reactions in people with hypersensitivity of the medication.
- ADRs are the leading cause of morbidity and mortality in healthcare, causing approximately 100,000 deaths annually.
- More than 2 million serious ADRs occur every year
- Nursing Homes experience approximately 350,000 ADRs per year.
This laboratory is regulated under the Clinical Laboratory Improvement Amendment (CLIA) of 1988 as qualified to perform high
complexity clinical testing. This test is used for clinical purposes. It should not be regarded as investigational or for research. The Analyte
Specific Reagents (ASR) used in this assay are not approved by the Food and Drug administration (FDA). FDA approval is not required
for the use of these ASRs. A normal genotype report indicates only the absence of the alleles tested above and does not imply that
other mutations are not present. Absence of a detectable gene mutation or polymorphism does not rule out the possibility that a patient
has an intermediate or poor metabolizer phenotype. This test does not detect polymorphisms other than those listed. Other
polymorphisms in the primer binding regions can affect the testing, and ultimately, the genotyping assessments made. Rare diagnostic
errors may occur due to primer site mutations. Mutations in other genes associated with drug metabolism will not be detected. Drug
metabolism may be affected by non-genetic factors. DNA testing does not replace the need for clinical and therapeutic drug monitoring.
The annotations and interpretations provided in this report are based on scientific literature and do not take into account drug-drug
interactions, medical conditions or other clinical factors that may affect medication response. Gene-drug interactions are ranked
according to guidelines, level of evidence and clinical utility. Current predicted phenotype and allele functionality may change in the future
depending on new evidence. Phenotype annotations for CYP2C9 are based on total activity scores as defined by CPIC79. The report
includes alleles of proteins involved in the metabolism of many medications. In rare cases, a variant that is not covered may be typed as
*1 or other variants. In the case of pseudogenes and mutations in the untranslated regions of genes, incorrect allele typing may occur
despite proper
The PharmacoCheck+ Personalized Medicine Panel detects all common and many rare genetic variants with known clinical significance:
Laboratory specimens were analyzed for the indicated genes using the PharmacoCheck+ Personalized Medicine Panel. The assay is
based on the Single Nucleotide Polymorphism (SNP) genotyping analysis of genomic DNA isolated from buccal swabs. The results meet
stringent quality control metrics for DNA isolation and genotyping. SNPs are processed in an OpenArray platform. Each call has an
estimated quality value >95%, based on the autocaller algorithm in the TaqMan® Genotyper software (ThermoFisher Scientific). Copy
Number calls are accepted when confidence values are >95%. Genomic DNA is extracted from the submitted specimen and amplified by
Real-Time Polymerase Chain Reaction (qPCR) using consensus oligonucleotide primers specific for the variants listed above coupled with
labeled probes for specific detection of each SNP. Amplification SNP genotyping analysis and Copy Number Variation (for CYP2D6) is
performed using the Real-Time PCR.
PCHS test kits are not intended to be a single source for medical decision-making. PCHS always attempts to
obtain the patient’s medication history either from the Referring Provider and/or third-party Pharmacy Benefit Managers for its
medication review. It should be noted that the medication profile could be incomplete and is dependent upon the information provided.
Pharmacogenetics Testing and the Personalized Medicine Report should not be a substitute for the medical decision-making and treatment
plan of the Prescriber.
The pharmacogenetic assay involves use of reporting software and genotype-phenotype associations. The software has not been evaluated by the Food and Drug Administration. The software, and the report generated by the software, is not intended to diagnose, treat, cure, or prevent any disease. A qualified designee within the lab uses the Software to generate and subsequently review the report. The pharmacogenetic report is one of multiple pieces of information that clinicians should consider in guiding their therapeutic choice for each patient. It remains the responsibility of the health-care provider to determine the best course of treatment for a patient.
Adherence to dose guidelines does not necessarily assure a successful medical outcome.
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