Cervical cancer/Oropharyngeal Cancer MRD Test kit (ctHPV16)
Digital PCR
Cervical cancer/Oropharyngeal Cancer MRD Test kit (ctHPV16)
It is suitable for patients with HPV 16 : ( 1 ) Auxiliary prediction of therapeutic effect ; ( 2 ) Recurrence monitoring after reaching treatment endpoint.
BACKGROUND

According to GLOBOCAN data, in 2022, there will be 661,000 new cases of cervical cancer and 348,000 deaths worldwide. The number of new cases and deaths ranks first in gynecological tumors[1]. The vast majority of cervical cancer is caused by persistent infection of high-risk HPV ( hrHPV ), and the E6 and E7 genes of the virus may be integrated with the infected patients DNA. hrHPV usually includes 14 types, of which HPV 16/18 account for more than 70%[2]. In addition to cervical cancer, a certain proportion of head and neck squamous cell carcinoma, anal cancer, vaginal cancer, vulvar cancer and other cancers are caused by HPV infection.

Circulating tumor DNA ( ctDNA ) is a tumor genomic fragment released into the circulatory system by tumor tissues, cells, etc. HPV integrated into the genome of the infected person is also released in the form of ctDNA [3]. Several guidelines have recommended ctDNA for the evaluation of Molecular Residue Disease ( MRD ). ctHPV is not interfered by wild-type background in circulating cell-free DNA and is easier to detect and identify than point mutations.


BACKGROUND
MRD AND TUMOR


A number of studies have used MRD for the prognosis and monitoring of cervical cancer and oropharyngeal cancer. Studies have found that patients with MRD positive at the treatment endpoint and/or during monitoring have poor survival data, and MRD can detect recurrence earlier than conventional methods [4-5]. Some other studies have suggested that the sensitivity of MRD based on digital droplet PCR ( ddPCR ) is better than that of realtime fluorescence quantitative PCR ( qPCR ) [6]. The detection performance of ddPCR is similar tohigh-throughput sequencing [7], and the method is simple and the cost is lower.



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PRODUCT INFORMATION
Using digital PCR to detect HPV type 16 E6 and E7 genes in the form of cell-free DNA that have been integrated into the human genome and released into the peripheral blood by tumors.. Before this test, it is necessary to determine the HPV 16.
※:Research Use Only
Project Name
Technology
Pack Size
Instruments Validated
Sample Type
Cervical cancer/Oropharyngeal Cancer MRD Test kit (ctHPV16)
Digital PCR
48 Tests/Kit
Bio-Rad QX200,etc
Plasma cfDNA
DETECTION SIGNIFICANCE


It is suitable for patients with cervical cancer, oropharyngeal cancer and other cancers caused by HPV 16  infection.:

(1)Auxiliary Prediction Of Therapeutic Effect : Multiple studies have confirmed that patients with MRD positive at the end of treatment and/or during monitoring have worse progression-free survival ( PFS ), disease-free survival ( DFS ), and overall survival ( OS )[4-5][8]

(2)Recurrence Monitoring After Treatment Endpoint : MRD can provide earlier indications of recurrence compared to conventional methods. For cervical cancer patients, the median lead time for detecting potential recurrence via MRD is 10 months prior to clinical confirmation, while for oropharyngeal cancer patients, this lead time is 6.6 months. [4-5].


Monitoring Scheme ( For Reference Only )


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FEATURES & ADVANTAGES
Leading Technology

Leading Technology

MRD testing can assist in predicting treatment efficacy and, compared to conventional methods, can provide earlier detection of disease recurrence by several months

High Sensitivity

High Sensitivity

The detection limit of ddPCR is as low as 1 ~ 3 copies per reaction, and the sensitivity is better than that of qPCR

Strong Specificity

Strong Specificity

The integrated tumor-derived ctHPV can be detected without cross-interference with the normal human genome and the other 12 hrHPV types

Quick Detection

Quick Detection

The operation is simple, the turn around time and detection cost are better than NGS