For the Phase I letter of inquiry, each component builder applicant must classify his or her proposal in one of the four Topic Areas below. 

In the letter of inquiry, applicants must explicitly link their technical goals with a specific set of improvements they plan to achieve for the proposed component.  The improvements can be described in the form of new target performance specification or in the form of desired goals. 

Component builders can submit more than one letter of inquiry to different Topic Areas, but each should only address one Topic Area. 

 Sample collection, concentration and preparation are critical components for diagnostics development.  Challenges in the area of sample collection include different protocols for sample volume, sample type (e.g. blood, urine, tissue, sputum, saliva, feces), and waste disposal.  Sample volumes for infants and children are frequently limited and therefore new technologies should lower the collection volume required.  In the area of sample concentration, we will invest in innovative approaches that are simple, require minimal reagents and power (e.g. no centrifuges).  In the area of sample preparation extraction, separation and cleanup protocols that work across a wide variety of sample types (e.g. blood, urine, tissue, sputum, saliva, feces), require minimal to no reagents and match downstream analysis sub-systems. 

It is very important for the sample preparation chemistry to be compatible with downstream detection assays.  For example, Component Builders should understand that downstream detection assays are potentially prone to interferents like detergents and salts, may have a narrow range of acceptable pH or temperature, need to maintain protein viability (storage), or require a certain level of DNA purity. 

In this topic area, we are looking for detection and amplification methods that advance the state of the art in terms of simplicity, performance and cost.  In spite of the expected gains from advances in sample preparation, the copy numbers or concentration of target molecules available for detection will frequently remain low.  Therefore, a sensitive molecular detection and analyte or signal amplification stage is likely to be needed for metabolite, nucleic acid and protein markers. 

One particular area of interest would be amplification methods that eliminate the need for thermal cycling.  We also welcome other innovative approaches with superior characteristics such as assay ruggedness, high specificity, quick time-to-answer, reduced cost and complexity, multiplexing, and quantitation capabilities.

In this topic area, we will invest in innovative methods to transduce the recognition of protein markers, biomolecular binding events, or amplification products into detectable readout signals.  We are particularly interested in platforms and technologies that enable multiplexed and multi-analyte readouts.

Under this topic area we will invest in additional innovations in critical components including micro-fluidic handling, packaging, power management, reagent handling, waste handling,  bioinformatics not captured under the previous three Topic Areas.