On May 8, 2022, Epiprobe announced that its independently developed three cancer gene methylation detection kits: TAGMe DNA Methylation Detection Kits (qPCR) for Cervical Cancer, TAGMe DNA Methylation Detection Kits (qPCR) for Endometrial Cancer, TAGMe DNA Methylation Detection Kits (qPCR) for Urothelial Cancer, have obtained EU CE certification and can be sold in EU countries and CE recognized countries.
The comprehensive application scenarios of the three DNA methylation detection kits
The above three kits are perfectly compatible with mainstream qPCR machines on the market. They do not require bisulfite treatment, makes the detection process simple and convenient. Single methylation marker applicable to all common cancer types.
Application scenarios of TAGMe DNA Methylation Detection Kits (qPCR) for Cervical Cancer including:
● Cervical cancer screening for women over 30 years old
● Risk assessment for HPV-positive women
● Auxiliary diagnosis of cervical squamous cell carcinoma and adenocarcinoma
● Postoperative recurrence monitoring of cervical cancer
Application scenarios of TAGMe DNA Methylation Detection Kits (qPCR) for Endometrial Cancer including:
● Screening for endometrial cancer among high-risk population
● Filling the gap in molecular diagnosis of endometrial cancer
● Postoperative recurrence monitoring of endometrial cancer
Application scenarios of TAGMe DNA Methylation Detection Kits (qPCR) for Urothelial Cancer including:
● Screening of urothelial cancer among high-risk population
● Outpatient cystoscopy pre-examination
● Evaluation of the results of surgery treatment in patients with bladder cancer
● Evaluation of chemotherapy in patients with bladder cancer
● Postoperative recurrence monitoring for urothelial cancer
The process of Epiprobe’globalization is progressing quickly，and products has passed European Union CE Certification.
At present, Epiprobe has established a professional registration team.
Meanwhile, combined with the innovative demand for the exploration of pan-cancer markers and companion diagnosis, Epiprobe has continued to advance product category expansion and R&D innovation. Since the three cancer gene methylation detection kits have obtained the EU CE certification, indicating that these products are in conformity with the EU in vitro diagnostic reagent medical device related directives, and can be sold in EU member states and countries recognizing EU CE certification. This will further enrich the company's global product line, enhance overall competitiveness, and perfect its global business layout.
Ms. Hua Lin, CEO of Epiprobe noted that:
With the concerted efforts of company registration, R&D, quality management, marketing and other departments, Epiprobe has obtained the EU CE certification of the detection products of cervical cancer, endometrial cancer, and urothelial cancer. Thanks to these efforts, the sales area of Epiprobe has been expanded to the European Union and related regions, which takes a solid step towards the realization of the global sales layout of the company's products. " Epiprobe will profoundly cultivate the global market for early cancer screening, and advance international markets and channels, relies on quality management and registration system, world-leading lab management methods and methylation detection technology, using the most advanced technologies and products to help global people, benefits the universe health.
About CE
CE Marking refers to a unified mandatory product certification mark for EU countries. The CE marking indicates that the products are in conformity with the basic requirements established by the relevant European laws on health, safety, environmental protection and consumer protection, and these products can be legally accessed to and circulated in the EU single market.
About Epiprobe
Founded in 2018, Epiprobe, as an upholder and pioneer of early pan-cancer screening, is a high-tech enterprise focusing on cancer molecular diagnosis and precision medicine industry. Building on the top team of epigenetics experts and profound academic accumulation, Epiprobe explores the field of cancer detection, upholds the vision of "keeping everyone away from cancer," committed to the early detection, early diagnosis and early treatment of cancer, which will improving the survival rate of cancer patients and enhance the health of the whole people.
Post time: May-08-2022