The Sprint Toward a Better SARS-CoV-2 Diagnostics Data System

A technology innovation contest held by the U.S. Department of Health and Human Services (HHS) aims to bring COVID-19 diagnostic tests to market with built-in, automated, harmonized data capture and wireless transmission capabilities. On December 16, HHS chose 16 winners from a pool of 31 applicants who will advance their technologies for commercial use in 2021.

The COVID-19 At-Anywhere Diagnostics Design-a-thon “harnessed the power of American ingenuity to ensure we have accurate, user-friendly reporting of COVID-19 testing results, especially those from rapid, easy to use tests,” said Assistant Secretary for Health Admiral Brett P. Giroir, MD, in a statement. Utilization of rapid diagnostics such as point-of-care, over-the-counter, and at-home tests is on the rise. However, these tests “often lack an easy way for users, such as schools, nursing homes, or businesses, to report results. This effort will address this gap,” said Giroir.

HHS received 31 final capstone project submissions among a pool of 363 registered participants. A panel of 16 public and private subject matter experts judged the final entries.

The Design-a-thon launched on November 9. This virtual technology “sprint” aimed to bring public and private sector innovators together to develop software and digital health tools that integrate with in vitro diagnostics (IVDs) to achieve two primary goals:

Align software developers, designers, and engineers with IVD device developers and COVID-19 subject matter experts to build software and digital tools that directly integrate with COVID-19 tests.

Build the infrastructure to enable flexible, extensible, automated, harmonized, device-agnostic diagnostic data reporting directly between HHS Protect and various reporting systems, called Wireless Automated Transmission for Electronic Reporting Systems.

This would result in simultaneous “packaging” and pushing of different datasets to different public health authorities. Such capabilities “will alleviate data collection and reporting burdens for patients, providers, anyone administering/using tests, and labs through which data is routed,” an HHS spokesperson told CLN Stat. “Perhaps most critically, these capabilities will be absolutely necessary (for data capture and reporting) when fully at-home, nonprescription, and over-the-counter tests are authorized and begin saturating the market,” the spokesperson added.