To use your product, SARS-CoV-2 nucleic acid is first extracted, isolated and purified from oropharyngeal (throat) swab, nasopharyngeal swab, nasal swab, and oral fluid specimens. Here’s how the letter digitally signed by the FDA’s chief science officer, Denise Hinton, describes the Curative test:
The company says that its tests have already been used by the City of Los Angeles since late March and have tested over 53,000 city residents.Ĭurative’s tests use an oral-fluid sample collected by having the subject cough to produce sputum, which release the virus from deep in the lungs, according to a spokesperson. We hope this will become a core piece of public health infrastructure.The diagnostics startup Curative has received an emergency use authorization from the Food and Drug Administration for its novel test to determine COVID-19 infection. “Curative’s simpler, safer process has taken testing to a new level, and together with Redox, we’ll help to not only control the spread of the disease but also be better able to allocate healthcare resources appropriately. “As we start to safely reopen the economy, state officials must have an accurate and efficient testing and contact tracing system,” said Niko Skievaski, co-founder and president of Redox. In this novel use case, Curative utilizes the Redox API to allow for a secure, efficient flow of data between it and public health authorities, further extending Redox’s network of more than 700 healthcare delivery organizations to include state public health agencies and regional HIEs. This networked approach to interoperability simplifies the way organizations exchange healthcare data by normalizing data formats and eliminating redundant connections. Redox standardizes healthcare data with a vendor-agnostic application programming interface (API) and a cloud network where organizations can exchange information. Redox allows us to be confident that this critical data will get to the right destination, in the proper format, and in a timely manner, so we can continue to focus on scaling out COVID-19 testing across the nation.” “Redox has given us a secure and scalable integration strategy to quickly automate this reporting requirement across all the different systems we need to work with. This can be challenging for an organization like ours, which is so focused on working as quickly as possible to scale up testing services nationwide,” said Isaac Turner, CIO and co-founder, Curative. “Every state has its own unique, mandatory reporting requirements for COVID-19 testing. Using its connection with Redox, Curative immediately sends test results to state officials for reporting, contact tracing programs, and to inform policies as regions move through phases for opening the economy. Curative offers an easy to use, accurate, and rapidly scalable oral fluid-based testing method that is less invasive, and which distributes results within just 48 hours. Other COVID-19 tests, such as the nasal swab and oral-based approach, are difficult for consumers to handle, are hard to administer en masse, or may pose a risk of exposure for healthcare workers. Since formalizing the partnership in May, the duo has kicked off projects with 24 states, with two, Illinois and Delaware, now fully live. Redox, Inc., a Madison, WI-based interoperability platform for healthcare data exchange, is working with FDA-authorized COVID-19 testing company Curative to safely connect patient data to state public health departments for notification of results. – In this novel use case, Curative uses the Redox API to allow for a secure, efficient flow of data between it and public health authorities, further extending Redox’s network of more than 700 healthcare delivery organizations to include state public health agencies and regional HIEs. – Since formalizing the partnership in May, the duo has kicked off projects with 24 states, with two, Illinois and Delaware, now fully live. – Curative and Redox have found a way to easily send COVID-19 test results to state officials for reporting, contact tracing programs, and to inform policies as regions move through phases for re-opening the economy.
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