Enhancing HIV and TB Diagnosis: Adjunct Technologies for Sample Collection and Processing - Frequently Asked Questions (FAQs)

Eligibility

Who is eligible for grants? 
This initiative is open to nonprofit organizations, for-profit companies, international organizations, government agencies, and academic institutions. We particularly encourage applications involving projects led by women or from women-led organizations and applications from institutions based in low- and middle-income countries.

Upon registration, applicants must provide information about the tax status of their organization as different terms and conditions may apply under the applicable tax laws. You should confirm your organization’s tax status with the appropriate advisor or entity within your organization such as your grants or contracts department, finance, or office of sponsored research. The funder may request additional information regarding your tax status. For information about tax statuses, you may check with your own advisors and review information on the applicable tax requirements.

What if our proposal includes something beyond the scope of sample collection and processing?
If you can connect the sample collection and processing to a test, that's ideal but not required for this RFP. We are focused on the collection and processing components, but strengthening the proposal with other aspects is fine.

What stage of product development does my test need to be in? What is the minimum technology readiness level required for submission?
There is no minimum for submission, but having gone through some level of development is preferred. Something beyond technology readiness level two or three is preferred. No data is required at the time of application, but any available data would strengthen the case.

Is FDA approval required for the developed technology?
No, FDA approval is not required.

What level of scientific evidence is needed to support a new diagnostic approach?
No data is needed at the time of application, although it helps strengthen the case. Data would be expected to be generated during the project.

Can existing diagnostic technology be considered if implemented in a new way?
Yes, existing diagnostic technology can be considered if implemented in a new way.

Would a novel near point of care diagnostic tool be eligible if it differs from the current call which focuses on sample collection and processing?
A test alone is not eligible. If it includes a component of sample collection and processing as part of the package, then it is eligible.

How strict is the requirement for NAT-based diagnostics? Would a technology with comparable sensitivity to PCR be eligible?
The focus is on sample collection and processing. If your sample collection and processing feeds into a new technology with comparable sensitivity to PCR, then it is eligible.

Does a novel device in Objective 4 primarily refer to reagent-based MTB lysis?
Yes, it refers to reagent-based MTB lysis. However, small, easy to use devices may also be considered.

Are there specific volume requirements for plasma collection for HIV detection similar to the one mL of whole blood requirement for TB?
There is no outlined amount of plasma required. The more the better, with a minimum expectation of around 40-50% recovery from at least 1mL whole blood would be ideal.

Are there restrictions on capillary versus venipuncture blood collection?
No, there are no restrictions as long as the test that follows is compatible with either collection method.

How long can collected TB or HIV samples remain viable before degradation?
For the purposes of the Grand Challenge, 24 hours for HIV samples and 72 hours for TB samples.

Does the grant support the purchasing of equipment for TB diagnosis, particularly for pediatric TB detection?
If equipment is required for the development of sample collection and processing solutions, then yes, it will be taken into consideration. However, routine clinical use equipment is not eligible.

Can the proposal focus on a different TB diagnostic approach than those listed, such as early TB detection or improving detection speed?
Improving detection speed may be eligible. The primary focus of this RFP is sample collection and preparation upstream of the diagnostic assay. As long as there is a sample preparation component tied to the TB diagnostic test, it will be eligible and within scope.

Is it possible to propose simultaneous detection of HIV and TB in the same test?
Yes, it is possible to propose simultaneous detection of HIV and TB in the same test.

Can we apply from a spin-off start-up company and have a PI from a university?
Yes, that is possible.

Are there any restrictions on sample types for TB, such as sputum, saliva, tongue swab, or breath?
The preference is for non-sputum specimens. Tongue swabs are further along in development and validation, but other non-sputum specimens may also be eligible.

Application Process

What must my application include? 
Please refer to the Application Instructions document.

Am I able to edit my proposal once submitted?
Yes, you may edit your proposal up until the specified deadline.

What amount of indirect cost is available?
Details of the foundation indirect cost policy guidelines can be found here: Gates Foundation's indirect cost policy.

Review Process

How does the review process work? 
Please refer to the Rules and Guidelines document.

Can I get a list of potential reviewers who might be assigned to my application? 
No. We do not make public the roster of reviewers.

Can I request that my application not be reviewed by a specific individual? 
No. However, we will ask reviewers to self-identify conflicts of interest and will not assign reviewers with conflicts.\

Will I receive specific feedback on my application if it is not selected? 
Due to the rapid proposal and review timelines applicable to this RFP, applicants with proposals that are not selected for award may receive a notification of decline without specific feedback.

Award Information

Are grant awards made directly to individuals? 
No. All awards are made to the organization where the individual holds their primary appointment. Institutions must agree to the terms and conditions governing each grant award prior to award activation.

How much money will each grant provide? 
We will consider proposals for awards of $100,000 to $250,000 USD for each project, with a grant term of up to 2 years. Application budgets should be commensurate with the scope of work proposed. Indirect costs will be considered and should be included in the budget for the up to the grant amount awarded (subject to the Gates Foundation's indirect cost policy).

Technical Support

I forgot my password. How do I reset my password? 
You can request to update your password within the application site. If you continue to have issues, please reach out to [email protected].

How will I know if my application was submitted? 
Once an application is submitted, an email confirmation will be sent.

I’m having trouble uploading my application file. What should I do? 
If you are having issues submitting your application, we would encourage you to submit from a different browser. If the issue persists, please email the specifics of your problem to [email protected].

How often do you intend to update the Frequently Asked Questions, and do you plan to provide answers to all questions submitted? 
We will periodically post answers to questions as they are submitted, but do not have a specific schedule. We will provide answers on this page that are of relevance and of general interest to potential applicants. For answers to specific questions that are not covered here, please email [email protected]