{"id":48537,"date":"2022-09-19T15:02:01","date_gmt":"2022-09-19T13:02:01","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/rheonix-covid-19-mdx-assay-receives-expanded-fda-emergency-use-authorization-to-include-saliva-home-collection-kit\/"},"modified":"2022-09-19T15:02:01","modified_gmt":"2022-09-19T13:02:01","slug":"rheonix-covid-19-mdx-assay-receives-expanded-fda-emergency-use-authorization-to-include-saliva-home-collection-kit","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/rheonix-covid-19-mdx-assay-receives-expanded-fda-emergency-use-authorization-to-include-saliva-home-collection-kit\/","title":{"rendered":"Rheonix COVID-19\u2122 MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva Home Collection Kit"},"content":{"rendered":"
\n

ITHACA, N.Y.–(BUSINESS WIRE)–Rheonix Inc<\/a>. announced today that the United States Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19\u2122 MDx Assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit. Rheonix\u2019s fully automated sample-to-answer COVID-19 assay received its initial EUA for use on a range of respiratory specimens on April 29, 2020. The EUA has subsequently been expanded to include use of saliva as a sample type and use by both moderate and high complexity laboratories.\n<\/p>\n

<\/a><\/p>\n

\nInitially, the Rheonix COVID-19 saliva home collection kit will be made available for use through Rheonix Laboratories, LLC, a New York State-permitted CLIA-compliant clinical laboratory located in Ithaca, New York. Rheonix plans to expand use of the home collection kit through partnerships with additional authorized laboratories.\n<\/p>\n

\n\u201cThe addition of a home collection kit expands individuals\u2019 access to a low-cost, highly sensitive COVID PCR test,\u201d said Greg Galvin, President, CEO and Chairman of the Board of Directors of Rheonix. \u201cWe have confirmed our test\u2019s ability to reliably detect the omicron subvariants, including BA.5. This is critical at a time when home antigen tests have been shown to be much less effective at detecting this highly infectious subvariant.\u201d\n<\/p>\n

\nSince early in the pandemic, Rheonix has been a leading provider of COVID-19 testing capacity in the eastern U.S. The company has been instrumental in providing easily scalable COVID-19 PCR testing capacity to community hospitals and local clinical laboratories, reducing turnaround time from two weeks to same day. Since April 2020, U.S. laboratories have processed more than 1 million samples using Rheonix\u2019s COVID-19 testing system.\n<\/p>\n

\nAbout Emergency Use Authorization Status:<\/b>\n<\/p>\n

\nThe Rheonix COVID-19\u2122 MDx Assay is an endpoint RT-PCR assay intended for the qualitative detection of nucleic acid from SARS-CoV-2 in respiratory and saliva samples from individuals who are suspected of COVID-19 by their healthcare provider. The Rheonix COVID-19 MDx Assay has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories. This test is also authorized for the qualitative detection of nucleic acid from SARS-CoV-2 in saliva specimens that are collected at home by individuals age 18 years and older (self-collected), 14 years and older (self-collected under adult supervision) or 5 years and older (collected with adult assistance) using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit, when suspected of COVID-19 by their healthcare provider. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and\/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.\n<\/p>\n

\nAbout Rheonix Inc.:<\/b>\n<\/p>\n

\nThe Rheonix Encompass workstations enable highly multiplexed sample-to-answer molecular testing for use in clinical, research and applied testing laboratories. Rheonix\u2019s clinical assays include the Rheonix COVID-19\u2122 MDx Assay for use under FDA emergency use authorization and the STI TriPlex\u2122 Assay for the detection of sexually transmitted infections in male urine. Applied testing solutions include the Beer SpoilerAlert\u2122 Assay, the most comprehensive beer spoilage panel available, and the Listeria PatternAlert\u2122 Assay, a rapid method for Listeria<\/i> strain typing. For more information, visit rheonix.com<\/a>.\n<\/p>\n

\nAbout Rheonix Laboratories, LLC:<\/b>\n<\/p>\n

\nRheonix Laboratories, LLC<\/a>,<\/span> is a New York State-permitted, CLIA-compliant laboratory located in Ithaca, New York. Rheonix Laboratories is permitted by the New York State Department of Health to provide COVID-19 PCR testing and results. The laboratory\u2019s flexible COVID-19 PCR testing program enables seamless registration, sample collection and testing for individuals and for organizations to provide low-cost testing to their populations. For more information, visit rheonixlabs.com<\/a>\n<\/p>\n

Contacts<\/b> <\/p>\n

\nLindsey Smith<\/b>
lindsey@pinckneyhugo.com<\/a><\/b>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

ITHACA, N.Y.–(BUSINESS WIRE)–Rheonix Inc. announced today that the United States Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19\u2122 MDx Assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit. Rheonix\u2019s fully automated sample-to-answer COVID-19 assay received its initial EUA for … [Read more…]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-48537","6":"format-standard","7":"category-industry"},"yoast_head":"\nRheonix COVID-19\u2122 MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva Home Collection Kit - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/rheonix-covid-19-mdx-assay-receives-expanded-fda-emergency-use-authorization-to-include-saliva-home-collection-kit\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Rheonix COVID-19\u2122 MDx Assay Receives Expanded FDA Emergency Use Authorization to Include Saliva Home Collection Kit - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"ITHACA, N.Y.–(BUSINESS WIRE)–Rheonix Inc. announced today that the United States Food and Drug Administration (FDA) has issued an expanded Emergency Use Authorization (EUA) for the Rheonix COVID-19\u2122 MDx Assay to include home collection using the Rheonix Laboratories COVID-19 PCR Test Saliva Home Collection Kit. 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