HealthPulse@home provides a faster, less expensive, hassle-free option for laboratories looking to offer COVID-19 specimen collection kits in the United States
Audere Receives FDA Emergency Use Authorization for HealthPulse home COVID-19 Specimen Collection Test Kit. (Credit: Gerd Altmann from Pixabay)
Audere, a digital health nonprofit developing solutions to improve global health, announced that it has received an Emergency Use Authorization (EUA) for HealthPulse@home from the U.S. Food and Drug Administration (FDA).1 Using the solution’s authorized labeling instructions, HealthPulse@home seamlessly allows CLIA-certified laboratories to bring their own self-collection COVID-19 specimen kits to market without needing to obtain their own FDA EUA.
HealthPulse@home provides a faster, less expensive, hassle-free option for laboratories looking to offer COVID-19 specimen collection kits in the United States. The HealthPulse@home authorized labeling instructions provide for custom branding, registration, and accessioning processes which require no additional usability studies.
Audere also provides recommended vendors and guidance for kit packaging, ordering, and accessioning, helping laboratories quickly bring new tests to market. The solution enables organizations to offer test kits for the unsupervised self-collection or collection by a caregiver of a nasal swab specimen.
“Despite progress made over the past two years, COVID-19 testing remains a pain point in the United States. With breakthrough cases and testing mandates for unvaccinated individuals, there is a continued need for a broad set of accessible testing options. HealthPulse@home aims to eliminate many of the barriers – time, cost, and effort – that currently prevent or delay laboratories from offering their own authorized self-collection kits. Through Audere and its partnerships with organizations like LumiraDx and Previon, we look to further democratize the availability of testing.”
– Paul Isabelli, Chief Operating Officer, Audere
HealthPulse@home enables CLIA-certified laboratories to better serve their communities by offering the convenience of at-home or remote testing. To date, HealthPulse@home has been certified for use with the LumiraDx SARS-CoV-2 RNA STAR Complete test assay.2 HealthPulse@home kits must be prescribed by a healthcare provider based on a clinical assessment or recommended by a public health agency. Audere is able to offer an end-to-end testing solution through its preferred partner, Previon. To learn more, visit healthpulsenow.org/test.
Source: Company Press Release