APROVIX
 
 

IMPORANT SOLUTION TO AN IMPORTANT CHALLENGE

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THE CHALLENGE

Across the world, cervical cancer kills hundreds of thousands of women every year.

Cervical cancer is one of the fourth most commonly occurring cancer in women and the eight most common cancer form in the world. Cervical cancer is caused by the sexually transmitted human papiloma virus (HPV). If a high-risk HPV type persists, cellular changes can eventually develop and with time mature into severe precancerous lesions that in turn may result in cervical cancer.

Most HPV infections are temporary and will clear out without doing any harm, but there are infections that are more longstanding which can lead to cell changes. HPV is often asymptomatic, if not women usually have inconvenience with bleeding between regular periods, bleeding after menopause, abnormal vaginal discharge, pelvic pain and pain/bleeding during sex.

Provided that HPV is detected early, an antidote treatment can be performed with 95% chance of success. Given that HPV infections can go undetected for years, cervical cancer can be dramatically reduced with HPV-tests taken on regular basis.

Cervical cancer screening has historically been based on cytology (PAP) tests that have high rates of false negatives and other inadequacies. With WHO’s recommendations1 and emerging clinical evidence, several countries have introduced new guidelines replacing PAP with HPV testing.

Even in countries with population-based screening programs women are under-screened. Between 20% to 50% of women who are called for screening do not show up for testing. This is often due to cost and availability constraints, discomfort in regards to gynecological examinations, or due to emotional or cultural reasons. At-home testing increases the participation rate in this group.

Want to know more about HPV? Read more here.

 
 
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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 lab 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.

 

The current shift, from cytology to HPV tests as the primary screening method, and the evident logistical and economic advantages of at-home self-sampling, suggests that HPV self-tests will be the default method of choice everywhere.

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 founded by Professor Erik Wilander, chief physician and professor in pathology and cytology, 2001. Collaborations with top researchers and institutions is 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

Technical documentation regarding the product family has been upgraded to comply with global regulatory requirements (IVDD 98/79/EC). In parallel, a mandatory quality system for international sale (ISO 13485) has been put in place.

Critical manufacturing and lab partnerships have been developed to allow the company to scale. Production has been outsourced to medical device specialist, Frohe AB, who will manage the entire production process including packaging, storage and shipping. At the other end of the value chain, Aprovix has established a strategic alliance with DNA lab, Dynamic Code.