FAQs

Frequently asked questions

1. Who can I contact for more information?

Please don’t hesitate to contact us by email at [email protected]

2. When can I apply?

Applications open on September 2, 2025, and close on November 20, 2025, 23:59 GMT.

3. Who can apply?

Applicants must be affiliated with a university, research institution, clinical laboratory, or other similar organization that meets the criteria set forth in the Terms and Conditions available on the ‘For applicants’ page.

4. How do I apply?

Applications must be submitted online at: submittable.com

5. Do applicants need to be nominated?

No. Applicants for each award need to submit their own applications.

6. When will I know if I have been shortlisted?

All shortlisted applicants will be announced in mid-March, 2026 and the final awardees (successful applicants) will be announced in mid-August, 2026.

7. Will I receive feedback on my proposal?

Unfortunately, no. Due to the amount of high-quality applications, we will not provide individual feedback on applications.

8. What are the assessment criteria and how will proposals be reviewed?

Each application will first be evaluated by scientific peer reviewers consisting of molecular diagnostics experts. A review panel will shortlist applications which will be initially compiled and announced (See FAQ number 6 above). Within the shortlist, the awarded applications will be selected by the review panel based on the criteria below. For applicants in the final stage, Seegene may perform an onsite evaluation as the final part of the assessment. Please refer to our ‘Panel’ page for more information on how the evaluation is conducted.

Assessment criteria:

Understanding and strategic application of molecular diagnostic product development tailored to the objectives of the designated project

Clinical study design and plan
Scientific background & rationale and potential clinical or societal impact
Applicant/team qualifications and project budget feasibility
Access to clinical specimens for the proposed development study plan
Final applications will be selected based fully on the voting of the review panel.

Full details are available on the ‘For applicants’ page.

9. What research disciplines are included in the scope of the award?

This year’s MDx Impact Grants focuses on conducting clinical studies for the designated UTI-DR project described in the scope information on the ‘For applicants’ page.

10. What is the maximum number of targets that can be configured?

A maximum of eighteen (18) target genes can be included, excluding internal controls. Please refer to the scope information on the ‘For applicants’ page.

11. If I submit the application, can I edit it before the deadline?

Yes, you can request to edit your submitted applications before the deadline (November 20, 2025 23:59 GMT).

12. How much is the award?

The final awardee will receive up to 600,000 USD. However, the budget may vary between countries and regions due to differences in the number of specimens required for the product, management costs and personnel. The total budget will be determined during the agreement after the final awardee has been announced. The budget will be confirmed at a later date, and the budget details are explained on the 'For applicants ' page for your reference.

13. How much is the consulting fee and how often is it made?

The final awardee may provide consulting services to Seegene by establishing a separate Consulting Agreement. Consulting fees will be included in the overall grant of 600,000 USD.

14. Can more than one grant application be awarded for this year’s programme?

Yes, more than one application may be awarded.

15. Is it possible to have sub-investigators?

Applicants can invite and collaborate with other institutions as sub-investigators to conduct cut-off evaluation and clinical studies. The applicant must ensure that the total of project expenses, including those for all the sub-investigators, are within the total grant provided by the award. The award will be made to the applicant who submits the application, and the applicant will be considered as a principal investigator for the awarded project. The project contract must be signed by the principal investigator who will be responsible for conducting and supervising all the project activities.

16. If our project is finished, can we publish the case study elsewhere?

Yes, but only with the prior written approval from Seegene. For details, please refer to the ‘Dissemination of results and promotional materials’ section on the ‘For applicants’ page.

17. Who is responsible for obtaining ethical approval?

The applicant must endeavour to support Seegene to complying with all the necessary ethical, legal, and regulatory requirements and other applicable guidelines to conduct the clinical study.

18. What are the responsibilities and obligations of the final awardees?

The final awardees are themselves responsible for (i) complying with all the necessary ethical, legal and regulatory requirements and other applicable guidelines in order to conduct and develop the clinical study and (ii) carrying out the proposed studies as described in the application and providing information related to the activities supporting the development upon the Sponsor’s request. For details, refer to the ‘Terms and Conditions’ page.

19. How are Seegene and Springer Nature involved?

The MDx Impact Grants are supported through a partnership between Seegene Inc. and Nature Portfolio, part of Springer Nature Ltd. Grant funding is provided by Seegene, while Nature Portfolio administers and promotes the programme. Nature Portfolio has convened a panel of internationally renowned researchers in molecular diagnostics to review proposals and make funding decisions. Nature Portfolio employees will have no influence over funding decisions. Seegene employees will conduct onsite evaluations for the finalists.

20. What materials and equipment are provided through the MDx Impact Grants?

Seegene will provide the final awardee with equipment-related consumables (tips, tubes, waste bags, PCR tubes, caps), reagents (extraction reagents and Seegene PCR reagent kits) and required equipment for Seegene product testing (CFX96 Dx, CFX OPUS96 Dx, STARlet, NIMBUS) throughout the duration of the project. Full details are available on the ‘For applicants’ page.

21. How many clinical specimens do we need to have in the cut-off evaluation and clinical study?

The number of clinical specimens may vary based on the study plan and the requirements for market approval sought by the product, but the recommended number for projects in general is as follows.

Clinical specimens: 60 positive specimens per pathogen and per specimen type and 60 negative specimens per specimen type are preferred.
Full details are available in the ‘Application form' and its Appendix 1 'Specimen and Site Info' document. You may still apply with an appropriate collection plan even if you do not meet all the requirements stated above.

22. Is it possible to use specimens from hospital environments (water sources or equipment), animals, and plants in addition to clinical specimens?

We are accepting applications intended to be tested on human-derived specimens only.

23. What if the prevalence of the specimen is rare, making it difficult to collect, or there is a shortage of specific target among specimen that I (applicant) have? Can connections be made with other institutions?

Applicants can collaborate with other institutions as sub-investigators for the procurement of clinical specimens. Please refer to FAQ number 15 for more information about sub-investigators.

24. Is it possible to use specimen that have been extracted and stored for cut-off evaluation and clinical study? What is the concentration of nucleic acids used in the experiment?

Experiments cannot be conducted using nucleic acids that have already been extracted and stored. Therefore, the concentration of nucleic acid is not predetermined.

25. Is it possible to use retrospective specimens? Can the grant be used to collect clinical specimens?

To ensure smooth progress in development, we prefer that applicants use clinical specimens they already possess. However, recognizing that it might be difficult to have all the proposed specimens, applicants may still apply if they present a plan to collect the specimens they currently lack before the clinical study begins. This plan must be included in the application. Applicants can apply budget for acquiring these specimens within the grant's direct costs, but separate funds for specimen acquisition will not be provided.

26. How does the development and clinical process work?

After the announcement of the final awardee, their proposal will enter Seegene's internal product development process. Development timeframes may vary based on product specifications and a detailed timeline will be provided exclusively to the final awardees. Final awardees (including their principal investigators) who submitted the proposals will be involved in a two-stage testing process.

The first stage involves a cut-off evaluation, where the product performance and assay cut-off confirmation are assessed using clinical specimens during the Feasibility phase. During this stage, the alignment between the developing product and the gold standard or comparator method results is confirmed. Following the cut-off evaluation, a prototype is produced, which is the final product before market launch. Once prototypes are produced, the final awardees (clinical sites) will conduct clinical studies, which focus on validating the overall clinical performance of the prototype. In this study, the concordance of positive and negative results between the prototype and the comparator method is compared to assess the product's clinical performance. This structured approach ensures comprehensive development and rigorous testing to bring effective products to market.

27. What should be used as the standard method and comparator?

We recommend using PCR products as comparators or gold standards. Additionally, to meet regulatory clinical requirements, it is essential to use commercialized devices as comparators.

28. If our project is finished, what is the next step?

After the completion of the proposed study, Seegene will seek to commercialize the assay, if feasible.

29. When is the best time to submit the Clinical Research Agreement (CRA)? Should the CRA be filled out and submitted during the submission phase, or should it be completed only after the proposal has been awarded?

The CRA is a formal contract and will be negotiated and signed after the proposal has been awarded. There is no need to prepare or submit the CRA during the application phase.

30. Can our proposal allow the development of probes and primers for the identified pathogen targets?

No, the probe/primers are developed by Seegene and are tailored to the targets.

31. Will the data of the clinical study be used for regulatory approval?

Yes, the clinical study result data will be used for regulatory approval thus the clinical study will be conducted within GCP practice and Seegene’s supervision.