CervicaDx
CervicaDx
The first product of Predica Diagnostics will be the ciRNAseq-based CervicaDx assay and a dedicated algorithm. Predica Diagnostics performs the CervicaDx test on cervical scrapes and analyzes the data with a software algorithm that provides a prediction if a woman is at risk of having or developing cervical cancer. Performing the CervicaDx test does not require that an extra scrape is taken.
Why the CervicaDx test
Cervical cancer is the third most common malignancy in women and fourth in mortality worldwide with 500,000 new cases and 250,000 deaths yearly. To reduce cervical cancer burden, national screening programs test for the presence of high risk human papilloma viruses (hrHPV, the causal agent of cervical cancer) in cervical scrapes. These tests have high sensitivity, but low clinical specificity: more than 97% of women who test positive for hrHPV (yearly 60,000 in the Netherlands) are actually healthy or spontaneously recover from HPV infection. Currently, many of these healthy women receive follow-up examination and a risky biopsy by a gynecologist. Only afterwards a woman is reassured that she is healthy.
Key features of the CervicaDX test
The CervicaDx assay combines high sensitivity with high clinical specificity. Because it is RNA-sequencing based the assay detects expression of hrHPV oncogenes, concomitant with specific hrHPV genotype information. Extensive scientific research has revealed that hrHPV is needed for cancer development, but not sufficient. Predica Diagnostics measures expression levels of many other genes that are expressed at higher levels in premalignant cervical lesions (cervical intraepithelial neoplasia or CIN) that need to be preventively excised. The CervicaDx test may be performed as a triage test on available cervical scrapes and vaginal self swabs that were tested hrHPV-positive making the logistics of implementation highly feasible. The test can also be requested for clinical indications outside population screening programs.
Service and collaboration
Current tests
Predica Diagnostics aims to bring its proprietary technology to patients in 1 to 2 years with a focus on developing the high-throughput CervicaDX test for cervical scrapes. In the next step of development, the CervicaDX assay will be expanded into a CervicaTissueDX assay for testing of tumor tissue, to guide treatment of advanced cancer patients.
Custom built test
Our technology is also of interest in other oncological indications, and Predica Diagnostics will set up collaborations or sublicensing possibilities for development and application of ciRNAseq technology in other oncology fields.
All you need to know
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