V-VEIL up3™ self-sampling solution for HPV & STI DETECTION

V-Veil-UP Production, European company registered in EUDAMED as a producer of Medical Devices, Systems, and Kit Producers, and at NAMMD, manufactures and sells V-Veil UP2™, the best patented Self-Sampling Veil to detect HPV & STI and UP2 Retrofitter™ Tubes. •J Safer, especially for those with lesions ■y High acceptability > 96% y Easy to use y Better screening approach

■S Self-Sampling Medical Device CLASS I according Regulation (EU) 2017/745 (CE mark under the responsibility of the manufacturer). ■S Registered in EUDAMED (the European database of medical devices) and NAMMD (the National Agency of Medicines and Medical Devices of Romania). S Produced in EN ISO 13485:2016 certified facility, in ISO 8 clean rooms. v' V-Veil UP2™ is listed as medical device for self-sampling into technology landscape report of Unitaid Screeningprecancerous lesions for secondary prevention of cervical cancer. ■S The self-sampling vaginal veil collector V-Veil UP2™ has almost twice...

V-VEIL UP2™ The self-sampling vaginal veil V-Veil UP2™ is a class I, non-sterile, UVC disinfected medical device, for the collection of secretions, various fluids and substances from the human vaginal cavity and cervix, for diagnosis by laboratory tests. HPV genotyping Vaginal Microbiome Chlamydia trachomatis Neisseria gonorrhoeae Ureaplasma parvum/ Ureaplasma urealyticum Mycoplasma Genitalium Mycoplasma hominis Trichomonas vaginalis Gardnerella vaginalis Herpes Simplex virus 1 Herpes Simplex virus 2 Syphilis (Treponema pallidum) I minimize leakinq accidents.

KIT 1.1 and KIT 4.1 , are also available, with 1 regular container for storage and transport of samples. V-VEIL UP2™ KITS are self-sampling procedure packs used to collect secretions, various fluids and substances from the vaginal cavity and cervix, for diagnosis by laboratory tests. V Suitable for all national HPV detection campaigns. V Very practical for NGOs that organize HPV screening campaign, especially in Muslim or hard to reach communities. v' The use of this veil makes it possible to almost double the detection capacity of HPV-HR by multiplex PCR in real time compared to a standard swab...

GROUNDBREAKING WORLDWIDE MEDICAL DEVICE INNOVATION Reduced risk of pre-analytical error and ease of use for automation The self-sampling medical device V-Veil UP2™ can be used with its patented, next generation UP2 Retrofitter™ tube, which allows the laboratory to use this primary tube with the collected sample, directly in the PCR automation system, without the need for an intermediate tube and another barcode. UP2 Retrofitter™ creates free empty space, in which the pipette of the preanalytical robot can be easily introduced, thanks to the same length and internal diameter of standard hemolysis...

The patient puts her sampling in the tube, then pushes it totally inside with the UP2 Retrofitter™ provided to her. After the veil is fully inserted, the patient presses the cap until a "CLICK" is heard three times, to completely close the sample. The veil is captured between the wall of the tube and the wall of the UP2 Retrofitter™, leading to a large free space, like a normal empty tube. 1. This patent pending technology allows the patient to use V-Veil UP2™, probably the No. 1 self-sampling device, in terms of efficiency, to detect HPV-HR (see international studies published). 2. The self-sampling...

Once the laboratory receives the UP2 Retrofitter™ Tube, with the collected sample, the laboratory technician: compatible, reaction interference-free elution media, that can be: S Reaction interference-free aqueous buffered collection medium V Tris-EDTA (TE) buffer (IX) pH 8.0 for molecular biology V Physiological saline solution V Universal Transport Medium V Viral Transport Medium V Usual cytological medium for HPV such as methanol-based or ethanol-based collection medium 3. Makes a rotation movement of the tube, to mix the liquid. 4. Vortexes the tube for 1 minute. 5. Inserts the tube directly...

• Neutrality with respect to molecular biology reagents • Compatibility with all HPV PCR Kits on the market UP2 RETROFITTER™ TUBE ADVANTAGES The patented technology V-Veil UP2™ with UP2 Retrofitter™ Tube, is suitable for all clinics, hospitals and laboratories, as it offers: V-Veil UP2™ with it's UP2 Retrofitter™ Tube, is safe and provides a more accurate result. LABORATORY ADVANTAGES: S No contamination S Economic ■S Ready for extraction

The Veil Technology releases all the biochemical molecules (90.7% ^ i DNA and 81.3% Proteins) contained in a woman's genital secretion. —' V-Veil UP2™ is up to 20% more efficient than swab. If more is released, more lives we save! conducted by the European Hospital Pompidou (Paris) - using 2 i Seegene™ reagents - demonstrates that collecting female genital secretions using V-Veil UP2™, a self-sampling device offered by V-Veil-UP Production, detects up to 2 times more HPV than swab. *Study published in scientific journals and medical congresses, available on the website hpv-veil.com Improved detection...

The patented, next-generation primary tube with UP2 Retrofitter™ allows laboratories to use the primary tube, containing ^ , the V-Veil UP2™ self-sampling device, directly with a preanalytical Sy robot, without the need for an intermediate tube and barcode. Direct use of the primary tube is optimal for HPV and STI molecular testing. Ease of use in terms of automation: Faster and more economical! Reduced risk of pre-analytical error. V-Veil UP2™ self-sampling device does not require transport fluid**, and the collected sample can be stored up to 30 days at 5 i room temperature, between 4 to 40°C,...

This study was performed on 253 adult women by the research team of the Laboratory of Virology of the Hospital Georges Pompidou in France. The graphic below compares the molecular detection of HPV genotypes performed from: _Genital secretions self-collected by women themselves, using the V-Veil UP2™ _Genital secretions collected by a gynecologist or a nurse, using a standard swab Comparison of effectiveness between two methods Vaginal Veil Collector V-VEIL UP2 LR-HPV Possibly Probably Carcinogenic Oncogenic Out of 253 included women, 90 were positive for HR-HPV with the V-Veil UP2, whereas only...