News » Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for Use in CLIA Waived Settings

01/03/2023Press Release

Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for Use in CLIA Waived Settings

Visby Medical announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test.

Visby Medical Receives FDA Emergency Use Authorization for Respiratory Health Test for Use in CLIA Waived Settings

San Jose, Calif. – January 3, 2023 – Visby Medical™ announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its
Respiratory Health point of care test. The Visby Medical Respiratory Health Test is a fast,
polymerase chain reaction (PCR) device that detects and differentiates between upper
respiratory infections caused by Influenza (Flu) A & B, and SARS-CoV-2 (COVID-19).

Visby Medical has created the first and only “instrument-free” platform that offers true PCR
technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Respiratory
Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes
at the point of care, enabling clinicians to accurately diagnose and treat patients.

Both the CDC and the Infectious Disease Society of America recommend clinicians should
use rapid molecular assays (i.e., nucleic acid amplification tests) over rapid influenza antigen
diagnostic tests (RIDTs) in outpatients to improve detection
(https://doi.org/10.1093/cid/ciy866; https://www.cdc.gov/flu/about/burden/index.html).
However, PCR testing has not been widely adopted in outpatient settings in part, because of
the expense required to adopt and maintain PCR instrumentation. The instrument-free Visby
Medical device solves this problem.

“Accurate, rapid, point of care testing can help physicians prescribe appropriate antiviral
medications, minimize viral transmission in waiting rooms, and improve patient satisfaction,”
said Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical. He further added, ”Use of the
Visby Respiratory Health Test at the point of care in urgent care clinics and emergency rooms
will transform how patients with respiratory symptoms are diagnosed and treated.”
This project has been supported in whole or in part with federal funds from the Department of
Health and Human Services; Administration for Strategic Preparedness and Response;
Biomedical Advanced Research and Development Authority (BARDA), under contract number
75A50121C00019.

About Visby Medical™
Visby Medical is transforming the order of diagnosis and treatment for infectious diseases so
clinicians can test, talk with, and treat the patient in a single visit. The Company developed a
proprietary technology platform that is the world’s first instrument-free, single-use PCR
platform that fits in the palm of your hand and rapidly tests for serious infections.
The Visby Medical Respiratory Health Test is the next phase in a robust pipeline that is
accelerating the delivery of fast and accurate, palm-sized PCR diagnostics to the point of
care, and eventually for use at home. For more information, visit www.visby.com. Follow Visby
Medical on LinkedIn.

This product has not been FDA cleared or approved, but has been authorized for emergency
use by FDA under an EUA for use by authorized laboratories. This product has been
authorized only for the detection and differentiation of nucleic acid from SARS-CoV-2,
influenza A, and influenza B, 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.

For the full FDA EUA letter, please visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas

Media Contact
press@visby.com

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