HPV DNA (23 genotypes) Diagnostic Kit from Sansure Biotech is Approved by NMPA
2022-08-10 yang, rongchang

HPV DNA (23 genotypes) Diagnostic Kit from Sansure Biotech is Approved by NMPA


Sansure Biotech Aug 10,2022

Recently, Human Papillomavirus DNA (23 genotypes) Diagnostic Kit (PCR-Fluorescence Probing) independently developed by Sansure Biotech was approved for marketing by NMPA (National Medical Products Administration). This marks a milestone for Sansure Biotech: the enterprise with the most certified products and the most complete solutions in the field of HPV DNA testing in China, adding a new competitive product to HPV diagnostic whole-scenario solution of Sansure Biotech.

HPV infection is an important factor resulting in multiple cancers: The construction of an efficient and precise HPV NAT system is accelerating worldwide

Human papillomavirus (HPV) infection is a common lower genital tract infection that causes serial lesions in the skin/mucous membranes of the genital tract. Persistent infection with high-risk HPV is the main cause of cervical cancer, while anal cancer, vaginal cancer and oropharyngeal cancer are also closely related to high-risk HPV infection, and low-risk HPV infection can also cause condyloma acuminatum or low differentiated squamous intraepithelial lesions and other related diseases.

Cervical cancer is the only cancer worldwide with a clear etiology that can be detected, prevented, and treated early. On November 17, 2020, WHO launched a global strategy to accelerate the elimination of cervical cancer, emphasizing the importance of HPV testing and screening. In July 2021, WHO updated the Guidelines for Screening and Treatment of Precancerous Lesions of Cervical Cancer and recommended high-risk human papillomavirus NAT as the preferred screening method for cervical cancer to promote the construction of an efficient and precise HPV NAT system worldwide.

Sansure Biotech’s HPV 23 genotypes: Multiple genotypes, multiple scenarios, more accessible

Highlight 1 Precise genotype coverage

Covering all 18 high-risk types and 5 low-risk types required by NMPA, precise genotypes, and whole-process quality control

Highlight 2 Efficient technical platform

Fast nucleic acid release technology/magnetic bead nucleic acid extraction technology, real-time fluorescence quantitative PCR, open and accessible universal testing platform

Highlight 3 Multi-scenario solution

Fully automated cup dispensing, nucleic acid extraction, adapting to multiple PCR instruments, report interpretation system, whole-process automation, multi-scenario application

The field of maternal and child health is the focus of Sansure Biotech, and Sansure Biotech has been conducting the in-depth study in the field for nearly 10 years. The marketing of HPV23 genotypes adds another competitive product to the efficient, precise and accessible Sansure HPV whole-scenario solution, helping improve the overall maternal and child health level.

Intuitive, systematic and scenarized: Sansure Biotech’s HPV full-scenario solution

1      Hospital outpatient/opportunistic screening

Providing 23-genotype and 15-high-risk-genotype kits, adapting to various automated solutions, precise genotype testing, providing more precise and reliable testing results for clinical practice

2      Mass screening/cervical cancer examination

Providing HPV13+2 kit, equipped with compatible cytological test preservation solution and fully automated solution of cup dispensing – extraction – amplification – report interpretation, reducing patient recall for repeat sampling, and improving screening efficiency

3      Physical examination/health management

Providing 23-genotype, 15-genotype and 15-non-genotype kits, etc., customized physical examination package, and diversified laboratory solutions

4      Rapid testing/primary and community hospitals

Providing POCT rapid testing option, delivering results in 40 min, achieving immediate screening and treatment, perfectly solving the challenges such as difficulty in follow-up at primary level, and difficulty in calling together

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