Zeesan receives China FDA approval for MeltPro® High Risk HPV Genotyping Assay

Zeesan Biotech announced that China Food and Drug Administration (CFDA) has approved its MeltPro® High Risk HPV Genotyping Assay recently.

The assay is based on the Multicolor Melting Curve Analysis (MMCA®) technology owned by Zeesan. The unique features distinguish this assay from its counterparts in the market as follows.

  1. All 14 high-risk HPV genotypes are identified in a single reaction. Up to 96 samples can be tested in one run within 3 h.
  2. The lyophilized master mix contains all the reaction components, which can be stored and transported at ambient temperature. Only sample DNA addition is required to start the reaction.
  3. When reaction is completed, the genotypic information of each sample is automatically displayed by the built-in software.

Zeesan provides both automated and semi-automated sample preparation protocols of different throughputs. One protocol can process 96 samples within half an hour consisting of 10 min hands-on time, another one can do 24~96 samples within 1 h consisting of 5 min hands-on time.

A 4-year clinical study on this assay was coordinated by Professor Youlin Qiao from the Cancer Hospital of the Chinese Academy of Medical Sciences, who was also the principle investigator for the clinical study on HC2 test (Qiagen) when it entered Chinese market.

The MeltPro® High Risk HPV genotyping assay was CE-marked in 2015. Its unique features immediately caught attention from Dr Gregory J. Tsongalis, a Professor of Pathology and Laboratory Medicine in Dartmouth Hitchcock Medical Center, Lebanon, NH, USA. His team applied this test successfully in the remote rural areas in Hondras and found an unexpected HPV distribution. They concluded that molecular testing using this Low and middle income countries (LMIC) deployable approach for the detection of HPV can aid in both the triage of HPV positive cytology-based follow up and provide information regarding HPV genotype distribution in support of vaccination strategies.

About Zeesan Biotech

Xiamen Zeesan Biotech Co., Ltd., is an ISO 13485:2003-certified manufacturer specialized in providing an integrated solution for personalized medicine, including molecular diagnostic instruments, reagents, and consumable materials. Our products are widely used in medical diagnosis for treatment of tuberculosis, leukemia, cervical cancer, and so on. More than 40 products have got CFDA approval and 17 products are CE marked for clinical use in Europe. Zeesan products are shipped to more than 30 countries with good feedback.

 

For further information, please contact info@zsandx.com

 


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