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BGI Genomics Multiplex Nucleic Acid Tests for Pathogens Certified in Thailand and Saudi Arabia

2023-02-27

BGI Genomics gene test kits certified for bacterial resistance genes, respiratory pathogens and CNS pathogens 

BGI Genomics' multiplex bacterial resistance gene detection kit, multiplex nucleic acid kit for respiratory pathogens and central nervous system (CNS) pathogen identification test kit based on PM Easy Lab, a fully automated medical PCR analysis system, have received market authorization from the Thailand Food and Drug Administration (TFDA) and the Saudi Food & Drug Authority (SFDA).

These three products facilitate clinical diagnosis and promote the informed use of antibiotics, especially for patients with central nervous system or respiratory tract infections.

Earlier, these products have been granted market access to the EU and registered with the Medicines & Healthcare Products Regulatory Agency (MHRA). The TFDA and SFDA approvals enhance the company's product matrix in Thailand and Saudi Arabia to accelerate its international expansion.

Infectious diseases caused by pathogens have remained a major health threat. Despite the widespread availability of vaccines and significantly improved sanitation and medical technology, three of the top ten deadly diseases worldwide are infectious diseases such as respiratory tract infections. Meningitis also remains the sixth leading cause of death from infectious diseases worldwide, with over 300,000 deaths caused by this disease every year.

Bacterial Resistance Genes Multiple Detection Kit



Bacterial Resistance Genes Multiple Detection Kit


Through the fluorescent PCR method, this multiplex bacterial resistance gene test kit is capable of simultaneously detecting four common drug-resistant bacteria, namely Klebsiella pneumoniae, Staphylococcus aureus, Pseudomonas aeruginosa and Acinetobacter baumannii, and five common drug-resistant genes with clear mechanisms of action, including NDM, KPC, OXA-23, CTX-M and MecA. This kit facilitates the diagnosis and treatment of patients with bacterial drug resistance to promote informed application of antibiotics, which is vital in the treatment of difficult and critical infections.

Multiple Detection of Nucleic Acid Kit for Respiratory Pathogens


Multiple Detection of Nucleic Acid Kit for Respiratory Pathogens

This multiplex nucleic acid test kit applies to nasal swabs, pharyngeal swabs, alveolar lavage fluid, and sputum sample types, and enables simultaneous detection of 14 common respiratory tract infection pathogens such as Influenza B Virus, Influenza A Virus, Mycoplasma pneumoniae, Respiratory Syncytial Virus, and Human Coronavirus in respiratory tract samples, thereby assisting in the rapid diagnosis and precise drug administration for patients with suspected respiratory tract infections (e.g., patients with severe pneumonia) in clinical settings.

Identification Kit for Pathogens Causing CNS Infection


Identification Kit for Pathogens Causing CNS Infection

This CNS pathogen identification kit detects the 12 most common pathogens of CNS infections, such as Streptococcus pneumoniae, Listeria monocytogenes, and Klebsiella pneumoniae, in a single cerebrospinal fluid sample. This kit screens patients with suspected central nervous system infections (e.g., encephalitis, meningitis).

PM Easy Lab

PM Easy Lab

These products represent the three core test kits of the PM Easy Lab pathogenic nucleic acid rapid test solution developed by BGI Genomics.

The PM Easy Lab pathogenic nucleic acid rapid test solution offers comprehensive coverage of a wide range of infectious agents, thereby addressing clinical pain points in a one-stop and cost-effective manner.

Apart from detecting a range of infectious agents, this solution is fully automated, portable and highly sensitive. It enables one-stop processing of the whole process from nucleic acid extraction to detection and reporting, which is built on BGI Genomics' years of accumulated experience in the field of infectious disease prevention and control.

PM Easy Lab features include requiring a small floor space, high portability, and no installation, making it suitable for mobile use. In case of sudden suspected infectious cases, it can be deployed to the scene quickly for testing and can be mounted on emergency vehicles as mobile emergency equipment.

It takes only 90 minutes to complete testing with high sensitivity. This enhances the productivity of the laboratory staff who minimize repetitive work. Furthermore, its unique design can avoid aerosol contamination and greatly enhance the safety of staff operation.

BGI Genomics has been consistent in infectious disease research and clinical transformation, and has published over 110 associated articles, participated in multiple projects and academic sharing, and completed the development and certification of many test kits for infectious pathogens, including the COVID-19 test kit, Adenovirus 41 test kit, Monkeypox test kit, etc.

The company looks forward to continuing its infectious disease research initiatives, launch additional customized services, and develop the relevant testing reagents to further contribute to precision medicine and safeguard human health.


About BGI Genomics

BGI Genomics, headquartered in Shenzhen, China, is the world's leading integrated solutions provider of precision medicine. Our services cover over 100 countries and regions, involving more than 2,300 medical institutions. In July 2017, as a subsidiary of BGI Group, BGI Genomics (300676.SZ) was officially listed on the Shenzhen Stock Exchange. 

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