Predica is a company, active in the field of diagnostics, prognostics and prediction of treatment response in oncology. With our first product, the CervicaDx test, we will focus on detection of cervical cancer. The Dutch population-based cervical cancer screening program currently relies on detection of the presence of DNA of high-risk human papillomavirus (hrHPV), the causative agent of cervical cancer, in cervical scrapes. This test is highly sensitive for detecting pre-malignant cervical lesions, but has a very low clinical predictive value. Because of this, yearly 42,000 women without any lesions in their cervix are being diagnosed as hrHPV-positive. These women have unnecessary worries and receive futile follow-up examinations. Apart from this, yearly 18,000 hrHPV-DNA positive women with cervical aberrations receive unpleasant and costly examinations by the gynaecologist. Of these women, more than 50% even receive follow-up invasive treatment by excision biopsy, with associated health risks, in retrospect without a medical necessity because no or merely minor pre-malignant lesions were present. In fact, only 10% of these 18,000 women is in real need of treatment. The huge overdiagnosis and overtreatment of women as a result of the current screening program in the Netherlands is therefore a major health, financial and social problem, which is recognized by the responsible authorities.
Predica offers the solution for this problem. With the CervicaDx test we can now measure activity of hrHPV, instead of merely the presence of the virus. It is the activity of the virus that is at the basis of cancer development. The test can be applied, as an additional test, on cervical scrapes that were already taken in the screening program, which makes the implementation of our test also very convenient. Apart from this, the CervicaDx test identifies if integration of the viral DNA in the host genome has occurred, a step which is considered the onset of cancer development. Using this information, a reliable risk assessment can be made about prognosis of disease. In a proof-of-principle study, the CervicaDx test has already been shown to be able to differentiate between hrHPV-positive women with no hrHPV activity and no cervical aberrations, and those with hrHPV activity. In women who are identified as ‘at risk’ because hrHPV activity and integration is detected, the CervicaDx test is also able to measure activity of an additional 250 genes that potentially play a role in cancer development. Predica will thereby not only reduce overdiagnosis, costly overtreatment and anxiety of healthy women, it will also provide guidance to optimal treatment for women who are actually at risk.
Predica needs an investment of M€2.7 for the retrospective and prospective validation studies, health technology assessment and CE-IVD-approval. We expect that this takes 4 years. Assays will be performed as a service to the customer. We will sell diagnostic tests and assay kits, together with a dedicated software package for data analysis.