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Funding Opportunity: Screening for Candida auris at point-of-care

Candida auris

Friday, September 27, 2019

New questions and answers added September 27, 2019!

The Wadsworth Center and Health Research Inc. are requesting applications from up to three investigators/inventors/companies to work closely with the Wadsworth Center to develop and optimize a point-of-care device that can detect the presence of Candida auris from a skin or nasal swab.

It is envisioned that the selected partner(s) will work with the Wadsworth Center to design and supply a functional prototype device(s) that meets the technical criteria that will be defined in the Request for Proposal (RFP). The Wadsworth Center will evaluate the device for sensitivity, specificity, reproducibility and ruggedness in comparison to the current gold standard laboratory methods. The partners will work together in a design/build/test cycle over the 18 months period to evaluate the device(s) and determine whether any have reached the “readiness to engage a manufacturer” stage. The total amount available for this funding opportunity is $750,000 and each of the selected applicants will receive $250,000 over an 18 months period.

Background

Infectious disease testing is being revolutionized by point-of-care diagnostic devices. These devices are being developed for use in healthcare facilities as well as for over-the-counter sale in pharmacies. The revolution is driven in part by advances in micro- and nanoscale technology enabling the development of microfluidic and microelectronic devices. By and large, these devices are good but do not yet achieve the sensitivity and accuracy obtained with larger and more complex instruments or traditional ‘gold standard’ tests. 

C. auris is an emerging fungal pathogen that presents a serious global health threat. The pathogen is often multidrug-resistant, meaning that it is resistant to multiple drugs commonly used to treat fungal infections. C. auris is difficult to identify with standard laboratory methods, and it can be misidentified in laboratories without special technology. C. auris misidentification may lead to inappropriate patient management, which can result in the spread of the disease.

C. auris was first identified in New York State in 2016. As of June 25, 2019 there were 339 clinical cases and 494 screening cases reported to the NYSDOH. As of July 12, 2019, the national clinical case count is 716 across 12 states with nearly 90% of cases in NY, NJ, and IL. CDC reports include an additional 1,342 patients found colonized with C. auris by targeted screening in ten states. C. auris cases have also been reported from several countries on different continents including 620 cases from six European Union countries for the period 2013–2017.

Clinical cases are people who are ill from the fungal pathogen.  Screening cases are people who are not ill but who carry the pathogen on their skin and are identified as part of our surveillance efforts. These cases can lead to spread of the fungal pathogen throughout a hospital or healthcare unit.

Most outbreaks of C. auris occur in healthcare settings, and infection is almost exclusively seen in people with complex healthcare needs, such as residents of nursing homes who require long term ventilator support and people with multiple ICU admissions. For this reason, it is important to quickly identify C. auris so that healthcare facilities can take special precautions to prevent its spread.

Questions and Answers

Q1 | We do not offer a point of care option that would meeting the requirements listed in the RFP. However, we do have the ability to automate the current method in place (real-time PCR LDT) into a sample-to-answer format. The simplified workflow would allow increased adoption of the C. auris LDT in other laboratories, as it would be much easier to run. Is this at all desirable? 

 

Q2 | While our platform does seem well aligned to address this clinical problem, we do not have an assay for this organism. Please advise if there is still interest.

Q3 | Am I allowed to submit two proposals using two different technologies (I have two collaborators with different technologies)?

Q4 | How much preliminary or proof-of-concept data are required for this submission? 

Q5 | Are we allowed to have co-investigators from CDC?

Q6 | Is it possible to have a Wadsworth Center PI listed as collaborator on the application?

Q7 | Will Wadsworth Center provide access to relevant isolates and DNA samples?

Q8 | Are we able to submit a similar proposal to Wadsworth Center and NIH?

Q9 | Is there a plan to provide a critique of applications after the awards decisions are announced?

Q10 | Are there any font, line or space limits in the preparation of the application?

Q11 | Are we able to modify or correct an application after submission?

Q12 | Would you publicly disclose any submitted grant materials?

Q13 | What is the recommended length for the LOI?

Q14 | Do you anticipate providing feedback on submitted LOIs?

Q15 | Is a budget breakdown required in the LOI?

Q16 | We see that one of the points for project scope discusses working closely to evaluate and optimize the prototype. Is this more of a research grant where the business is leading the development or is it more similar to a contract where the Wadsworth Center is leading development and the business is executing?

Q17 | Do you have any further details about how shared IP ownership has historically occurred with Wadsworth Center?

Q18 | Should a contract be awarded, is there potential for continued partnerships to further develop the device?

Q19 | Can we talk on the phone more about what you are looking for, and how our platform could meet those goals?

Q20 | Can we obtain examples of a successful RFP and report following the project completion?

Q21 | Can we have a follow-up conversation with a person in charge, to clear up any remaining questions?


Additional Questions Received as of August 19, 2019

Q22 | Are you looking for a “high-risk, high-payoff” technology, e.g., similar to the Small Business Innovation Research (SBIR) program, or do you have an interest in implementing the technology at the Wadsworth Center / Health Research Inc. soon after the 18 months period? What is your envisioned timeframe for a proposed technology to have a “major public health impact” – Would you prefer a highly innovative or a relatively mature technology closer to “manufacture ready”?

                     

Q23 | What is the longer term goal/interest of the Wadsworth Center / Health Research Inc., in the post RFP project period: e.g., generate a joint/shared intellectual property, being involved in a potential further commercialization, a full implementation of the developed platform and assays at the Wadsworth Center / Health Research Inc. and/or broader; future expansion of the platform and assay panels to other infectious/cancer diseases of interest to Wadsworth Center / Health Research Inc.? Do you have any preferred business models in the collaboration / commercialization steps (e.g., venture capital, merger/collaboration with a larger, dominant diagnostics company)?

  

Q24 | Should a commercialization plan/status, and/or a present financing plan be included as a part of the proposal? Would the reviewers examine the commercial potential and aspects of the proposed technology, and should the sections addressing current competitive technology on the market, a value proposition, market size, etc., be included in the proposal?

  

Q25 | Could you comment on some aspects or models how you envision the intellectual property to be shared, e.g., company “background intellectual property” (already in place) vs. intellectual property developed during the project in the collaboration with Wadsworth Center / Health Research Inc.?

  

Additional Question Received as of August 22, 2019

Q26 | Our company has already developed a working prototype of a portable and rapid molecular diagnostic device (it has not been approved by FDA yet) and it has been tested with another fungal diagnostic panel, but not C. auris. Question is: are we still eligible to apply for this funding as this funding is for developing a device?

 

Additional Questions Received as of September 27, 2019

Q27 | Is there any limit on the number of references?

 

Q28 | Does the six-page limit apply to references cited in the application.

 

 


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