THE CHALLENGE
HPV infection
A genital Human Papillomavirus (HPV) infection is very common. At the age of 50, about 4 out of 5 women have had an HPV infection and most do not experience any symptoms of the infection. HPV infections usually heal by themselves but for a few, the infection persists which can lead to cell changes that in turn can develop into cervical cancer. An HPV infection can be detected with a DNA test for HPV.
HPV causes cervical cancer
Cervical cancer is caused by a persistent infection of the sexually transmitted virus HPV.
Cervical cancer is a major and global health problem
By 2020, it is estimated that 600,000 women will be diagnosed with cervical cancer and half of them will die from the disease[1].
Cervical cancer is the fourth most common cancer in women and the eighth most common cancer in the world.
Cervical cancer can be prevented
Cervical cancer can be prevented through preventative measures such as vaccines and screening.
The purpose of screening is to detect cancer development in time. Given that a development against cancer is detected at an early stage, it can be stopped with treatment. All adult women are recommended to be screened for cervical cancer every few years, including women who have been vaccinated. Vaccine does not cover all types of HPV that can cause cancer.
The most common screening method in our part of the world has been based on cytology. Following new clinical evidence[2] and recommendations from i.a. The World Health Organization (WHO), a number of countries, including Sweden, have shifted screening method from cytology to HPV tests.
Want to know more about HPV? Read more here.
[1] Sims et al. Lancet Oncology, 2019
[2] Ogilvie et al., Jama 2018 ul 3;320(1):43-52
THE SOLUTION: QVINTIP®
Qvintip® is an at-home, easy-to-use, self-test solution for HPV detection with the same accuracy as sampling performed at a clinic. With the device, women collect a vaginal fluid sample and the detachable tip is then removed and sent to a laboratory for analysis.
Qvintip’s® self-sampling kit has been deemed, by women in clinical studies, to be the most comfortable and easy-to-use self-sampling device on the market.
QVINTIP HPV TEST
With the ongoing shift from cytology to HPV tests as the primary screening method, and the evident organizational and economic advantages of at-home self-sampling, HPV self-tests should be the default method of choice everywhere eventually.
Qvintip® represents a new, affordable and convenient way to detect HPV before malignant cell changes occur, giving infected women the best prospects of starting a potential treatment early.
Qvintip® was developed by Professor Erik Wilander, chief physician and professor in pathology and cytology, Uppsala Universitet, Sweden 2001 and evaluated in collaboration twith the Cytology Laboratory at Uppsala University Hospital. Collaborations with top researchers and institutions remains a cornerstone of Aprovix’ strategy. To date, the device has been used in 21 clinical studies including 25,000 women and additional clinical studies including 15,000 women are ongoing. Click to learn more about research and studies
CERTIFICATIONS AND PARTNERSHIPS
Technical documentation regarding the product family comply with global regulatory requirements (MD 93/42/EEC, IVD 98/79/EC).
Aprovix is certified according to ISO 13485, a comprehensive quality management system for the design and manufacture of medical devices.
Critical partnerships in production and laboratory operations have enabled the company to expand. Production is carried out according to validated and controlled processes at Frohe AB, a production company with long experience in manufacturing of medical technology products. Aprovix has also established a collaboration with the DNA laboratory Dynamic Code, which develops and performs analyzes in its quality assured laboratory.