A qualitative test kit for detecting and genotyping human papillomavirus (HPV) in cervical exfoliative cell samples using fluorescent PCR methodology. The kit is part of Xenta's molecular detection platform for HPV screening.
Manufactured by
China
Xenta Biomedical Science Co., Ltd, founded in December 2021 and headquartered in Guangzhou Development District, is a national high-tech enterprise focused on the R&D, registration, and commercialization of in vitro diagnostic (IVD) reagents and devices. With fully paid-up capital of RMB 10 million, the company is led by a team of returnee PhDs with strong international research and industry experience. It is dedicated to developing innovative POCT technology platforms under the philosophy of "Faster, Better, and More Accessible". The company drives innovation through R&D centers in Guangzhou, Xiamen, and overseas. Using its proprietary dry light-excited chemiluminescence POCT platform, it has developed leading product series and managed major national research projects. The company has published over 20 SCI papers, holds 70 patents, has obtained more than 60 EU CE certifications, and 12 FDA approvals in the United States. Currently, several product lines are actively striving for NMPA certification. Its pipeline covers key areas including cardiovascular, inflammation, oncology, hormone, and infectious diseases, demonstrating end-to-end capabilities from R&D to global commercialization. The core team comprises graduates from top universities such as Texas A&M University, Xiamen University, Sanford-Burnham Medical Research Institute, and Sun Yat-sen University, possessing multidisciplinary expertise in biomedicine, engineering, and law. The co-founders have extensive experience from leading IVD companies, having previously guided teams to achieve annual revenues exceeding several hundred million yuan and secure over 200 product certifications worldwide. Since its establishment, Xenta Biomedical Science Co., Ltd has raised tens of millions in funding and obtained ISO 13485 certification, supporting its global expansion.
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GUANGZHOU BIOTRON TECHNOLOGY CO., LTD. · China
A fluorescent PCR melting curve method-based detection kit for identifying Human Papillomavirus (HPV) 31 genotypes. This diagnostic kit is designed for molecular diagnostics applications and enables precise genotyping of HPV infections.
Igenesis(Shanghai)Co.Ltd. · China
This diagnostic kit uses real-time multiple fluorescent PCR technology combined with an Automated Fully Enclosed qPCR Instrument. It is used for in vitro qualitative detection of high-risk HPV16, HPV18, and 16 other high-risk types (HPV26, HPV31, HPV33, HPV35, HPV39, HPV45, HPV51, HPV52, HPV53, HPV56, HPV58, HPV68, HPV59, HPV66, HPV73, and HPV82) in cervical exfoliated cells or reproductive tract secretions. Test results assist in HPV auxiliary diagnosis.
ACON Laboratories, Inc. · United States
A nucleic acid-based PCR test kit for genotyping of human papillomavirus. Provides comprehensive identification of HPV strains for clinical assessment.
Shenzhen Uni-medica Technology Co., Ltd · China
In vitro qualitative detection kit for 15 high-risk HPV E6/E7 mRNA subtypes in cervical exfoliated cell samples. Detects HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68 for cervical cancer and precancerous lesion risk assessment. NMPA Class III medical device registered.
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A real-time PCR reagent kit for the detection and differentiation of human papillomavirus types 31, 33, and 35 DNA with quantitative detection capabilities.
Yaneng BIOscience (Shenzhen) Co.,Ltd. · China
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Igenesis(Shanghai)Co.Ltd. · China
A fully enclosed diagnostic kit with preloaded reagents for 6-plex detection of HPV types (HPV16, HPV18, and others) using cervical exfoliated cells and genital secretion samples. The kit employs magnetic beads extraction, purification, and qPCR method with results available within 2 hours and internal control monitoring throughout the process. It requires no freezer storage or transportation.
BioTeke Corporation(wuxi) Co.,Ltd · China
Molecular diagnostic test for human papillomavirus detection using polymerase chain reaction technology. Enables nucleic acid-based identification of HPV pathogens for clinical screening applications.
Shenzhen Uni-medica Technology Co., Ltd · China
A diagnostic kit for qualitative detection of 15 high-risk HPV E6/E7 mRNA types (16, 18, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 68) in cervical exfoliated cell samples. The kit detects HPV at the viral gene transcription level, directly reflecting the expression of HR-HPV E6/E7 oncogenic genes, and is closely associated with viral integration and cellular malignant transformation. It can serve as a risk assessment tool for cervical cancer and precancerous lesions, providing accurate information for cervical cancer screening and disease prediction.
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