InBios International, Inc. announces the U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for its diagnostic test that can be used immediately by CLIA high-complexity laboratories in the U.S. to detect nucleic acid from SARS-CoV-2
SEATTLE (PRWEB) APRIL 08, 2020
InBios International Inc., a leading developer of diagnostic tests for emerging infectious diseases, announced today that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Smart Detect SARS-CoV-2 rRT-PCR Kit. This real-time PCR test is intended for the qualitative detection of nucleic acid from SARS-CoV-2, the virus that causes COVID-19, in human nasopharyngeal, anterior nasal and mid-turbinate nasal swab specimens from individuals suspected of COVID-19 by their healthcare provider. Clinical laboratories that are certified under Clinical Laboratory Improvement Amendments (CLIA) in the U.S. can immediately begin using this kit, which offers results in about 4 hours. This kit has been validated on the popular Applied Biosystems 7500 Fast Dx Real-Time PCR and the Biorad CFX96 Touch Real-Time PCR Detection System instruments.
Dr. Syamal Raychaudhuri, InBios’ chief scientific officer, said, “From the very early days, we (InBios) have been quick to respond to emerging global public health threats such as Zika, dengue and West Nile virus, but also cautious to only release products we are confident are of the highest performance and quality. The Smart Detect SARS-CoV-2 rRT-PCR Kit upholds our commitment to these high standards during this time when it is critical to meet the need for accurate testing for COVID-19.”
The Smart Detect SARS-CoV-2 rRT-PCR Kit is available to order immediately. It is the first of several diagnostic test kits being released by InBios to help diagnose COVID-19. In the coming weeks, serology kits for antibody detection will be available, which could help expand and contribute to a wider testing of the population that may be infectious for SARS-CoV-2 virus.
InBios is ramping up production of its COVID-19 diagnostic tests to meet the worldwide need. In 2018, InBios relocated to a larger, modern facility in South Lake Union area of Seattle, Washington, and has successfully increased production capacity and automation to support the ever-increasing demand for its high quality kits to support diagnostic testing during outbreaks of Zika, dengue, West Nile virus and now COVID-19.
While the Smart Detect SARS-CoV-2 rRT-PCR Kit has not been FDA cleared or approved, it has been authorized for use by the FDA under an EUA, which permits use of certain medical products that may be effective during a public health emergency, which was declared for COVID-19 on Jan. 31, 2020. The test 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. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
For more information about InBios COVID-19 tests, visit: https://inbios.com/covid-19/
InBios International Inc. specializes in the design, development and manufacture of diagnostic devices for emerging infectious diseases and biothreats. Founded in 1996 in Seattle, WA, our superior quality products are accurate, easy to use and cost effective. InBios offers an extensive catalog of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified.