About HPV. Human papillomavirus (HPV) is a group of viruses that are extremely common worldwide. Theree are more than 100 types of HPV, of which at

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1 Cervical Cancer & HPV

2 What is HPV Human papillomavirus (HPV) is a group of viruses that are extremely common worldwide. About HPV Theree are more than 100 types of HPV, of which at least 13 are cancer-causing (also known as high risk type). HPV is mainly transmitted through sexual contact and most people are infected with HPV shortly after the on nset of sexual activity. HPV is so common that most people get it at some time in their lives.

3 Cervical Cancer & HPV Infe ection Nearly all cases of cervical cancer can be attributable to HPV infection. Those infected with HPV, 50% of them will fortunately clear the virus within 8 months, 90% of them within 2 years. From WHO

4 Cervical Cancer Epidemiolo ogy Cervical cancer is a cancer that arising from the cervix, and can spread from the surface of cervix to ot ther parts of the body. Cervical cancer is the 2nd most common cancer in women living in less developed regions with an estimated new cases in 2012 (84% of the new cases worldwide). In 2012, approximately 270,000 women died from cervical cancer; more than 85% of these deaths occurring in low- and middle-income countries. From WHO

5 HPV Types Disease Plantar warts HPV Type 1, 2, 4 Common warts 1, 2, 4, 26, 27, 29, 41, 57 Flat warts 3, 10, 27, 28, 41, 49 Genital warts 6, 11, 30, 40-45, 51, 54 Cervical cancer Precancerous changes Laryngeal papillomas 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 68, 73, and 82, also called High-risk HPV Types 16, 18, 34, 39, 42, 55 6, 11, 30

6 HPV Product list 1. HPV (Type 16 and 18) (1 PCR tube for the 2 types) High-risk HPV (1 PCR tube for the 15 types without Genotyping) 3. High-risk HPV DNA ( 15 Genotypes) Genotyping) 4. HPV DNA Diagnostic Kit (1 PCR tube 5. HPV (Type 6 and 11) (1 PCR tube for (4 PCR tubes for the 15 types with for other types) the 2 types)

7 Patented NA extraction on ne-tube for manual, automated process Step one : centrifugation of 1 ml from cytobrush media Step two : Add 100 ul lysis buffer to pellet Step three : Add 5 µl of specimen to master mix save time avoid aerosol contamination reduce the loss of nucleic acid 10 minutes in total labor time

8 Nucleic Acid extraction and mix PCR automation 96 samples in 45 minutes

9 Features 1. Minimize contamination risk Nucleic acid lysis in chemical reagents at room temperature, without heating, minimizes aerosol contamination and false positive results 2. One-tube technology International pioneered one-tube technology, without elution, nucleic acid can be directly used for sample loading and amplification in the PCR tube 3. Fast and economic Only 45 minutes for pre-processing of 96 samples manually, saving operating time, 2 hours turn-around-time without heating, without high-speed centrifuge and without elution, saving laboratory equipment costs 4. Internal control (IC) monitor Internal control (IC) participate in the whole process to minimize false negative results 5. Full automation enabled Combined usage our fully automatic nucleic acid extraction system realize the automatic detection, to avoid manual operation error, improve work efficiency and accuracy, and achieve the standardization of laboratory testing

10 Performances Clinical performance between Sansure 15 High-risk Human Papillomavirus DNA Diagnostic Kit and pathological diagnosis result HPV result Pathological diagnostic result CIN1- CIN2+ Sensitivity 93.75%( ) Specificity 78.47%( ) Negative Positive predictive value 79.23%( ) Positive Negative predictive value 93.48%( )

11 Abstract Main features of HPV solutions CE-IVD Accreditation Portée A Validated media: BD surepath / Hologic Extraction : One tube / room temperature/ 96 samples in 45 min Q-PCR multiplex / ADN E6/E7 15 HPV Diagnostic HR : 16,18 and pool (31,33,35,39,45,51,52,53,56,58,59,66,68) 15 HPV Genotype HR : 16,18,,31,33,35,39,45,51,52,53,56,58,59,66,68 2 HPV Diagnostic BR : 6 and 11 1 plateform > 250 samples / day Bidirectional connection + B-globine Open system: Kras / Braf / EGFR / ALK etc.

12 Category Product Name Tests / kit Abbreviation Products Hepatitis Hepatitis B Viral DNA Quantitative Fluorescence Diagnostic Kit 48T HBV-FAST list Chlamydia Trachomatis DNA Fluorescence Diagnostic Kit Ureaplasma Urealyticum DNA Fluorescence Diagnostic Kit 48T 48T CT-FAST UU-FAST STDs Neisseria Gonorrhoeae DNA Fluorescence Diagnostic Kit 48T NG-FAST Herpes Simplex Virus Type 2 DNA Fluorescence Diagnostic kit 48T HSV2-FAST Chlamydia Trachomatis/Ureaplasma Urealyticum/Neisseria Gonorrhoeae DNA Diagnostic Kit (PCR-Fluorescence Probing) 48T CT/UU/NG Human papillomavirus (6 / 11) DNA Fluorescence Diagnostic kit 48T HPV6/11-FAST Cancer-related Biomarkers Respiratory Tract Diseases Prenatal & Postnatal Care Human papillomavirus (16/18) DNA Fluorescence Diagnostic kit 48T 15 High-risk Human papi illomavirus Genotyping DNA Fluorescence Diagnostic kit High-risk Human papillomavirus DNA Fluorescence Diagnostic Kit 48T HPV-FAST Human Papillomavirus Epstein-Barr virus DNA Quantitative Fluorescence Diagnostic Kit 48T EBV-FAST Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit 48T TB-FAST Mycoplasma Pneumonia DNA Fluorescence Diagnostic Kit 48T MP-FAST Human Cytomegalovirus DNA Diagnostic Kit (PCR-Fluorescence Probing) DNA Quantitative Fluorescence Diagnostic Kit 24T HPV16/18- FAST HPV-FAST 48T HPV T HCMV-FAST

13 Fight with Cervical Cancer

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