Tempus, a leader in artificial intelligence and precision medicine, today announced the launch of the Tempus iC Home Collection (1), a COVID-19 test with unsupervised self-collection at home.
Physicians can now order the Tempus iC Home Collection test for eligible patients and have the collection kits shipped to their homes for unsupervised self-collection at home. Tempus has received emergency use authorizations (EUA) from the U.S. Food and Drug Administration (FDA) for the Tempus Nasal Sample Collection Kit and iC SARS-CoV-2 PCR test.
The Tempus iC Home Collection test includes sample collection instructions with free overnight shipping to its CAP-accredited and CLIA-certified lab, with results typically available within 24 to 48 hours of the lab receiving the sample. This new offering follows the launch of Tempus’ original PCR COVID-19 test in May 2020, providing patients with more options while furthering our goal of expanding COVID testing across the country.
Tempus also announced the launch of the Research Use Only (RUO), amplicon-based, high-throughput next-generation sequencing (NGS) assay for the detection of mutations from the SARS-CoV-2 virus. The assay includes 2019-nCoV primers designed to detect mutations and characterize RNA from the SARS-CoV-2 virus to help researchers identify and track the emergence and prevalence of novel strains of SARS-CoV-2.
“It’s imperative that high throughput labs like Tempus continue to both innovate and scale their testing capabilities,” said Eric Lefkofsky, Founder and CEO of Tempus. “Since launching our original COVID test at the beginning of the pandemic last spring, we have tested more than 2 million people. This new at home sample collection test will dramatically broaden the market we can reach, making our tests more accessible, while sequencing will continue to broaden our understanding of viral mutations and spread.”
Learn more about the Tempus iC Home Collection test and additional COVID-19 testing offerings here.
(1)This product has not been FDA cleared or approved but has been authorized for emergency use by FDA under an EUA for use by the authorized laboratories;
- This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
- The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
Tempus is a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare. With one of the world’s largest libraries of clinical and molecular data, and an operating system to make that data accessible and useful, Tempus enables physicians to make real-time, data-driven decisions to deliver personalized patient care and in parallel facilitates discovery, development and delivery of optimal therapeutics. The goal is for each patient to benefit from the treatment of others who came before by providing physicians with tools that learn as the company gathers more data. For more information, visit tempus.com.