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Infertility is a common problem that impacts every sixth couple in the world. From these cases the cause is genetic in 15% of men and 10% of women. Overall, infertility affects 25 million people in Europe.

Rīga Stradiņš University (RSU) has developed GENTERF, a single testing kit that can identify the known and common clinically important genetic mutations in both men and women. The kit can also be used to detect mutations in order for precision medicine and carrier testing to be carried out.

Description of the technology and the offer

In vitro diagnostic medical device (know-how), including: 

  • description of the methodology (know-how) for preparing the testing kit;
  • an IT solution developed according to the GENTERF testing kit to analyse results and obtain clinical responses based on the latest scientific literature;
  • documentation demonstrating analytical and clinical performance in accordance with Cabinet Regulation No. 689;
  • the registered trademark GENTERF.

Description of development stage and results

  • A GENTERF testing kit has been developed at the RSU Scientific Laboratory of Molecular Genetics. It has been accredited in accordance with ISO 15189-LATK-633-00-2020 standard for medical laboratories.
  • GENTERF Analytical sensitivity - 99 % and specificity - 99 %.
  • GENTERF clinical trial plan been drawn up in accordance with ISO 20196:2019 standards.
  • Clinical trial is carried out in accordance with Cabinet Regulation No. 891.

Features and benefits

  • Faster diagnostics of underlying causes of infertility;
  • Improved clinical decision making;
  • Opportunity for personalised treatment based on test results;
  • Lower overall treatment costs due to better diagnostics and targeted treatment;
  • Lower risk of postnatal pathology due to included carrier testing.

Offer

Licensing options when licensing know-how:

  • upfront payment;
  • royalties;
  • annual minimums;
  • milestone payments.

Other options will be considered.

Inventor profile

Archive

Genetic test for simultaneous detection of genetic variations important for reproduction, Part 1

Technology type

  • DNA Testing Kit
  • Software for obtaining clinical results based on up-to-date scientific research
  • In vitro diagnostic medical device

Technology summary

Infertility is a frequent problem that impact every sixth couple in the world and out of these – a genetic cause is prevalent in 15 % of men and 10 % of women. Infertility in Europe is prevalent in 25 million populations.

Rīga Stradiņš University (RSU) has developed an innovative genetic test that allows to identify known frequent clinically important genetic mutations for both men and women in a single test kit, includes mutations for precision medicine and carrier testing. The method can be used in any standardised molecular biology laboratory and result is obtained within one day.

Stage of development

  • Developed DNA Testing Kit, tested on 400 individuals
  • DNA Testing Kit validated with external quality assurance schemes and positive DNA control samples

Features and benefits

  • Faster diagnostics of underlying cause of infertility
  • Improved clinical decision making
  • Opportunity for personalised treatment based on test results
  • Lower overall treatment cost due to better diagnostics and targeted treatment
  • Lower risk of postnatal pathology, because of included carrier testing

Invitation to purchase exploitation rights of genetic test for the detection of reproductive disorders, developed by Rīga Stradiņš University

RSU announces the negotiation procedure for the purchase of the exploitation rights of intellectual property (know-how) rights or conclusion of licence agreement with regard to a new and innovative genetic test developed within the project of applied researches of the European Regional Development Fund (ERDF) that enables identifying the most common genetic causes of infertility and provides information for decision taking with regard to the most optimal treatment method.

The test is designed for the detection of reproductive disorders both in men and women. For more information, follow this link

Important notice for the candidates

Anyone interested is invited to participate in the negotiation procedure by putting forward a financial proposal.

The negotiation procedure may take place in several forms: an electronic form, a written form by mail or fax or a face-to-face meeting during which minutes are taken. Proposals put forward in a written form should be authenticated by the signature of the candidate. Candidates putting forward their proposal during face-to-face meeting should sign the minutes of the meeting, whereas, proposals put forward by fax or e-mail prior to the proposal submission deadline should be authenticated by the signature (in the form of a letter, letter of application of meeting minutes) or by a secure electronic signature. The proposal should be signed by a chair of the board or an authorised person.

Proposal submission deadline: 22 August 2016.

Licence agreement shall be concluded with a candidate having offered the highest price for the respective object of intellectual property. If any of the candidates refuses to conclude the agreement, rights to conclude the agreement shall be transferred to the candidate having offered the next highest price.

Contact person for all matters concerning the negotiation procedure: Linda Gabrusenoka (phone: +371 67409087; e-mail: linda[pnkts]gabrusenokaatrsu[pnkts]lv). Contact person for specific matters concerning the method (genetic test): Linda Gailīte (e-mail: linda[pnkts]gailiteatrsu[pnkts]lv)

Negotiation procedure for the assigning of the exploitation rights of intellectual property objects with an aim to ensure successful commercialisation of intellectual property developed within the projects is governed by Regulations No. 14 of the Cabinet of Ministers.

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