SOW.pdf

STATEMENT OF WORK FOR PURCHASE OF RoverDX

1.0 Introduction/Background:

With the recent resurgence of Lunar exploration through both Gateway and surface missions, crew members are faced with a high risk of radiation including that of Solar Energetic Particles (SEP) in Solar Particle Events (SPE, equivalent to SEP Events). SPE are particularly troubling due to their severity and randomness: crew members’ only defense is to predict the events and shield themselves, however they may only have a few minutes of notice and Lunar Gateway offers little shielding. If the crewmembers are exposed to radiation it is critical that they take medication in relation to the effective dose of radiation they received: not enough medication will not mitigate the risk and too much medication will cause severe unnecessary side effects.

Currently the only way to determine the radiation dose is physical dosimetry: a wearable device that shows the amount of radiation the crew members were exposed to. However, humans (particularly humans in space) are highly heterogeneous in their reactions to radiation and physical dosimetry is unable to capture this information to inform proper medication dosing. In order to understand individual crew members’ reactions to radiation events and properly dose sensitive medication there is a need to develop microgravity compatible radiation biodosimetry technology which currently does not exist.

In the past, radiation biodosimetry assays have utilized biomarkers such as cytokines and proteins, which were unreliable and inaccurate. However, just last year the Jacob laboratory developed and patented an assay utilizing miRNA-150. miRNA are small non-coding RNA molecules found in plants, animals and some viruses that functions in post-transcriptional regulation of gene expression. This method is highly accurate and we hypothesize it will be at radiation doses relevant to those of SPE on the Lunar Gateway. However, this method currently requires qPCR: a time and laboratory equipment dependent method of detecting, characterizing, and quantifying nucleic acids such as miRNA.

Many groups have sought to develop a qPCR device compatible at the Point of Care (POC) due to the large number of assays that it would enable. While there are commercial RT-PCR devices, no groups have been successful at developing a qPCR method beyond a purely academic setting until now. The Sia Laboratory at Columbia University has recently entered the final development phases of the RoverDX: a commercial POC qPCR device for COVID-19 saliva swabs. Such a breakthrough is tremendously exciting, and through a strategic partnership we seek to use this device as a reference when creating POC qPCR technology compatible with Dr. Jacob’s miRNA radiation biodosimetry assay.

2.0 Scope of Work:

(1) Verify RoverDx such that it is compatible with human blood qPCR.

a. Identify a sample preparation procedure such that target miRNA is amplified and quantified

b. Verify that the sample preparation procedure is sensitive to miRNA changes in proton-irradiated human blood

(2) perform a first set of testing to see if the RoverDx system is microgravity compatible by placing it on all 6 sides and running a test.

3.0 Applicable Documents/Background:

4.0 Description of Tasks/Technical Requirements:

1. Test that while using a benchtop procedure, the RoverDX system is able to amplify the target miRNA (miR-150-5p&miR-23a-3p).

2. Test the RoverDx in 6 orientations as a preliminary check that it may be microgravity compatible.

MEETING FREQUENCY/DATE DURATION LOCATION

Research progress meetings

Quarterly 1 hour MS Teams

5.0 Deliverables:

1 RoverDX POC qPCR system