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Development of a Home Phenylalanine Monitor  

STATUS: Awarded
ACTIVE SOLVERS: 15
POSTED: May 30 2014
SOURCE: InnoCentive

Phenylketonuria (PKU) is a rare inherited genetic disorder that affects approximately one in 15,000 babies born in the USA. Effective management of PKU requires rapid and easy-to-use measurement of blood phenylalanine, but current blood tests for phenylalanine require a visit to a clinician or a self-administered blood draw and subsequent testing by a laboratory. 

The National PKU Alliance (NPKUA) is sponsoring a 3 Phase Challenge program to create a home, or point of care assay platform to quantitatively measure phenylalanine concentrations in peripheral blood of patients to facilitate better management of PKU through more regular and timely feedback. Milestone 1 requires a detail Project Plan of the solution proposed in Phase 1 (Home Test for Phenylalanine – Challenge 9933401).  Milestone 2 requires the generation of proof-of-concept test data from positive control blood samples. Milestone 3 builds upon the previous tasks and involves the validation of the home monitor with clinical blood samples from PKU patients. 

NPKUA intends to make up to 6 awards from a total award pool of $60,000 for Milestone 1, up to 3 awards of $50,000 each for Milestone 2, and a final award of up to $200,000 for successful completion of Milestone 3. During this course of this Challenge, additional participants may be invited to join at the discretion of NPKUA. 

This is a Reduction-to-Practice Challenge that requires a written proposal and experimental proof-of-concept data.

Challenge ID: 9933564
 
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Challenge Overview

The National PKU Alliance’s (NPKUA’s) mission is to improve the lives of individuals with PKU and pursue a cure. Although dietary maintenance and other treatment strategies are valuable in helping individuals manage their disease, these strategies are best combined with rapid, easy, and sensitive testing of blood phenylalanine levels to avoid the side effects of elevations in phenylalanine or its derivatives, such as phenylketone. Currently, PKU patients collect small blood samples and send them for testing, but patients must wait several days to two weeks before obtaining results. During this time, spikes in blood phenylalanine may cause lasting damage, especially in children. 

Solvers are requested to produce a home phenylalanine monitor as proposed in their winning solution to Home Test for Phenylalanine – Challenge 9933401. A submission to this Challenge should include the following:

  1. Milestone 1 – A detailed Project Plan addressing the specific Solution Requirements presented in the Detailed Description of Challenge 9933401 (see below). This description should explain the methods, materials, personnel, resources, schedule, capability to produce a manufacturable prototype, and potential limitations to reaching Milestone 2 & 3. The Project Plan must be received by 11:59 PM (US Eastern Time) on July 16, 2014.
  2. Milestone 2 – A prototype for testing sham, spiked, whole blood samples over a range of phenylalanine (phe) levels obtained from an appropriate medical research facility (facilitated by Seeker if necessary) and proof-of-concept test data. The data and a visual of the assay technology must be received by 11:59 PM (US Eastern Time) on December 1, 2014.
  3. Milestone 3 – Validation data from clinical blood samples from PKU patients obtained from an appropriate metabolic disease research laboratory (facilitated by the Seeker if necessary). A range of phe levels from normal (<2 mg/dL), hyper phe PKU (6-10 mg/dL), mild PKU (10-15 mg/dL), moderate PKU (15-20 mg/dL), and classical PKU (>20mg/dL) should be tested. Results must be received by 11:59 PM (US Eastern Time) on June 15, 2015. 

The award is contingent upon theoretical evaluation of the Project Plan (Milestone 1) and experimental confirmation of the submitted data sets (Milestones 2 & 3) by the Seeker. 

To receive an award, the Solvers will have to transfer non-exclusive IP rights to the Seeker.

What is InnoCentive?

InnoCentive is the global innovation marketplace where creative minds solve some of the world's most important problems for cash awards up to $1 million. Commercial, governmental and humanitarian organizations engage with InnoCentive to solve problems that can impact humankind in areas ranging from the environment to medical advancements.

What is an RTP Challenge?

An InnoCentive RTP (Reduction to Practice) Challenge is a prototype that proves an idea, and is similar to an InnoCentive Theoretical Challenge in its high level of detail. However, an RTP requires the Solver to submit a validated solution, either in the form of original data or a physical sample. Also the Seeker is allowed to test the proposed solution. For details about treatment of IP rights, please see the Challenge-Specific Agreement.

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