Our goal in providing a COVID-19 home testing and online consultation service is to leverage our substantial clinical, technical, and operational expertise to address this unprecedented global pandemic.
Our service allows symptomatic and at-risk patients to get tested, receive their results, and consult with an experienced medical provider without having to leave their home. This service expands much-needed access to accurate and reliable testing, reduces possible exposure of others to the virus, and alleviates the burdens faced by in-person healthcare providers.
Given new guidance from the FDA on March 21, specific to self-collection laboratory testing, Nurx and our longstanding and trusted laboratory partner Molecular Testing Labs have made the responsible decision to pause on providing any additional self-collection COVID-19 tests.
Molecular is in direct communication with the FDA regarding this most recent guidance. Molecular continues to have high confidence in the test characteristics and accuracy of its self-collection COVID-19 test.
Neither Nurx nor Molecular has reason to doubt the accuracy of Molecular’s COVID-19 self-collection test given the sensitivity and specificity data collected to date. Molecular’s assay is carefully designed to ensure that a proper self-collection has occurred.
We strongly agree with FDA’s position in its recent guidance that there is “public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection.”
As a trusted healthcare company, Nurx believes we are uniquely positioned to responsibly contribute and safely connect people with testing, education, and care. The most important action we can take at this time is to support public trust in the FDA during this public health emergency. This continues to be the priority of Nurx, and we stand ready to help expand needed and appropriate testing and will continue to explore ways to be supportive in the meantime.