Visby Medical’s test for COVID-19 is the first PCR-based, single-use test that is designed to be simple to operate; the palm-sized device is able to provide results in less than 30 minutes. By eliminating the long lead time to results and integrating the entire PCR process into one machine, Visby’s invention could vastly expand the possible use cases for PCR test results.
The PCR technique is a process of exponential DNA or RNA replication. Through controlled heating and cooling of sample material in the presence of specially designed enzymes, billions of copies of target genetic material are created. Without this amplification process, a sample with a small viral load — such as from an asymptomatic carrier of COVID-19 — would go unnoticed. This is why PCR is considered the gold standard in diagnostic testing; it is maximally specific and highly sensitive, and hence it offers the best chance of finding a pathogen.
Visby Medical COVID-19 test has been authorized by the FDA under the EUA for the qualitative detection of SARS-CoV-2 RNA in:
a) Nasopharyngeal, nasal, or mid-turbinate swabs collected by a healthcare provider (HCP), or
b) Nasal or mid-turbinate swabs self-collected (in a healthcare setting) from individuals who are suspected of COVID-19 by their healthcare provider.
Emergency use of this test is limited to authorized laboratories, certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests.
For the full FDA EUA letter, please visit: https://www.fda.gov/medical-devices/coronavirus-disease-2019-COVID-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas
The Visby Medical COVID-19 test has not been approved or cleared by the FDA. This test has been authorized by FDA under an EUA for use by authorized laboratories; This test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens. This test 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 authorization is terminated or revoked sooner.
For more information, visit www.visbymedical.com