Recently, Wuhan Yzy Med Technology Co., Ltd’s new product “Human Glucose-6-Phosphate Dehydrogenase Gene Mutation Detection Kit (PCR-Fluorescent Probe Method)” has been approved by the State Drug Administration and obtained the registration certificate for Class III medical devices from the State Drug Administration (NMPA). No.: CNIS20243400286.
This is another Class III medical device product registration certificate harvested by YZY Med in the field of pharmacogenomics, following the approval of the Hypertension Pharmacogenetics and HLA-B*5801 genetic testing products. Up to now, YZY Med has a total of 8 Class III registration certificates for its pharmacogenomics products, making it one of the head enterprises in the industry with the largest number of Class III medical device product registration certificates for pharmacogenomics.
Glucose-6-phosphate dehydrogenase (G6PD) deficiency is the most common inherited enzyme deficiency disorder, caused by a mutation in the G6PD gene on chromosome X that results in reduced or absent erythrocyte membrane G6PD enzyme activity and reduced production of reduced nicotinamide adenine dinucleotide phosphate (NADPH), a coenzyme of glutathione reductase in the pentose phosphate pathway. –Reduced nicotinamide adenine dinucleotide phosphate (NADPH) production, reducing the production of reduced glutathione to maintain the stability of the erythrocyte membrane and unable to resist oxidative damage, ultimately leading to destruction of erythrocytes and hemolysis, the patient is often due to the consumption of fava beans and the onset of disease, commonly known as “fava bean disease”. Patients often develop the disease by consuming fava beans, commonly known as “fava bean disease”. Some heavy patients can cause severe hyperbilirubinemia in the neonatal period or induce life-threatening non-immune hemolysis under specific conditions (oxidative stress, food or drugs).
The Expert Consensus on Newborn Screening, Diagnosis, and Treatment of Glucose-6-Phosphate Dehydrogenase Deficiency and the Technical Guidelines for Genetic Testing of Drug-Metabolizing Enzymes and Targets of Drug Action (Trial) suggest that testing for mutations in the G6PD gene may assist in confirming the diagnosis of G6PD deficiency. Prevention is the key to this disease. With G6PD genetic testing, we can identify patients at risk earlier and take appropriate preventive and intervention measures.
Product significance and applicable people
- Early detection, early prevention: G6PD gene test can help you identify potential health risks earlier and take corresponding preventive measures to effectively reduce the risk of diseases.
- Family genetic risk assessment: If there are already cases of related diseases in your family, G6PD gene test can help you assess your own genetic risk and take more targeted health management strategies.
- Scientific guidance on medication: Knowing your G6PD gene status can help you choose medication more scientifically and avoid adverse reactions caused by medication.
People of childbearing age/pregnant women
The test provides early information on whether you are a carrier and provides lifelong guidance on medical treatment and medication for you and your child.
Newborns
Provide lifelong guidance for your child’s medical treatment.
Children
To be informed of the risk in advance and to avoid the occurrence of fava bean disease by accidental ingestion of fava beans or misuse of medication.
Fava bean disease/anemia patients and their relatives
Genetic testing can identify the cause of the disease, and relatives of patients with fava bean disease are at high risk and should be screened early.
Couples with a child born with serovar disease
Couples with normal enzyme metabolism (in the case of heterozygous mothers) who have a child with fava bean disease should undergo genetic testing to identify the cause of the disease and provide guidance for the birth of a healthy second child.
Advantages
①Easy operation ②Open reagents ③Simple reading ④High specificity ⑤Contamination prevention system
