Diagnostics

Novel Markers for Male Fertility Diagnosis - Vim3 and Mxi-2 for determing sperm quantity and quality

Ref.-No. 4631-5554

Keywords: biomarker, diagnosis, rapid/quick test, rapid result fertility test marker, marker for fertility, sperm, spermatozoon, motility of sperms, morphology, motility, fertility, fertility test, ejaculate, spermiogram/semen analysis, Vimentin 3, Vimentin 3 staining, human, veterinary, livestock breeding

Novel antibody-based biomarkers allow male fertility diagnosis for determining sperm quantity and quality. The antibodies target truncated forms of the sperm proteins Vimentin 3 (Vim3) and Mxi-2, which identify the following characteristics: Vim3 is only expressed in normal sperms (e. g. ejaculates with normozoospermia), and Mxi-2 is only expressed in abnormal sperms (e. g. ejaculates with oligo-astheno-teratozoospermia (OAT) syndrome and azoospermia). Besides a reduced number of sperm cells, deformation and immobility of sperms (abnormal sperms) cause an insufficient sperm quality, which can now be determined by using the antibodies anti-Vim3 and anti-Mxi-2. The determination of the ratio enables the differentiation of pathological subtypes. In addition, the novel antibody-based diagnosis of sperm quantiy and quality offers advantages compared to the WHO-recommended standard procedure (spermiogram):

  • Fresh and frozen ejaculates can be used (@ RT: > 1 h or @ -20 °C: several weeks).
  • Semen donation can be made at home.
  • Determination of quantity and quality of the same sample.
  • Consistencies in the results (reliable and objective determination).

Competitive Advantages

  • Vim3 and Mxi-2 staining as reliable markers for determining sperm quantity and quality
  • consistent results by reliable and objective determination
  • results available within 30 minutes by FACS and immunofluorescence, within 3 hours by ELISA
  • ejaculates usable @ RT: > 1 h or @ -20 °C: several weeks

Commercial Opportunities

The antibodies can also be used for the development of diagnostic tests based on systems with automated cell analysis. Anti-Vim3 and anti-Mxi-2 antibodies are part of pending diagnostic patent applications for which a licence is offered.

Current Status

Until now, 120 patients were analyzed and categorized according to the nomenclature of the WHO. Vim3 and Mxi-2 expression were analyzed by different methods (ELISA, FACS).

Relevant Puclications

Pending patent applications: PCT/EP2018/058923 and PCT/EP2019/084015

von Brandenstein M. et al., (2018), Beyond the 3’UTR binding: microRNA - induced protein truncation via DNA binding, Oncotarget, 2018; 9:32855-32867

Funke T. et al., (2019), Vimentin 3 Allows Differentiation between Normozoospermia and Oligoasthenoteratozoospermia. Disease Markers, 2019 Dec 10;2019:9803498

Huerta M. et al., (2021), EBV-induced loss of sperm quality, Turkish Journal of Urology, 2021

An invention of Uniklinikum Köln.

Dipl.-Biol. Kordula Kruber

kk@provendis.info
+49 208 9410530