The development of an accurate host genetic diagnostic assay for women with subfertility
| Reference number | |
| Coordinator | Uppsala universitet - MED VETENSKAPER OCH KLIN BAKTERIOLOGI |
| Funding from Vinnova | SEK 801 312 |
| Project duration | October 2015 - May 2020 |
| Status | Completed |
| Venture | Eurostars |
| Call | Eurostars medfinansiering 2014-2015 |
Important results from the project
To develop a diagnostic test that identifies an increased risk of chlamydia-associated subfertility in women. The test is based on genetic biomarkers in women and should be a support in fertility investigations. Biomarkers (single-nucleotide polymorphisms, SNPs) have been identified and an assay has been developed. A limited validation has been made but the development of a commercial product has not been completed.
Expected long term effects
A method based on 18 human SNPs was developed at the prototype level for a commercial assay. The method was tested on samples from> 1000 subfertile women. Due to changed clinical routines for fertility problems, demand has decreased drastically during the project´s five years. The companies involved Elucigene and TubaScan have therefore decided not to proceed with marketing and CE-IVD certification of a final assay. However, the project has resulted in an assay which with so-called KAPS technology can be used for epidemiological and scientific studies.
Approach and implementation
The project consisted of five parts. 1: A prototype of the method was developed where the composition of reagents was defined. 2: A biobank with samples from subfertile women was created as a basis for testing the developed method. 3: Samples from the women were analyzed for 25 SNPs involved in pathogen recognition and inflammation resulting in 18 SNPs to the final method. 4: Software was created to provide a user-friendly assessment report with risk measures for subfertility in the method. 5: The final assay was validated.