09/16/2020 • Press Release
Visby Medical’s Personal PCR Device Receives FDA Emergency Use Authorization for Moderate-Complexity Lab Environments
Seven-year-old startup emerges from stealth mode, provides adaptable and rapid testing technology to frontline lab personnel fighting the pandemic
SAN JOSE, CA — The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) on September 16, 2020, for Visby Medical’s single-use Personal PCR (polymerase chain reaction) device, a rapid test for detection of COVID-19.
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 need for such accessibility has been abundantly clear since the earliest days of the pandemic, especially in light of the limitations of turn-around time inherent to lab-bound PCR, the gold standard of infectious disease testing.
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
“We are humbled by the FDA’s decision,” said Dr. Adam de la Zerda, founder and CEO of Visby Medical. “The COVID-19 crisis has shown that we don’t just need more testing; what we really need are accurate results delivered quickly. If you care about accuracy, PCR is the right way to test for COVID. We are excited that Visby Medical’s Personal PCR device will now provide rapid and accurate testing to lab personnel fighting the pandemic at the frontlines.”
“Healthcare and medical professionals trust the PCR technique for its reliability and high accuracy,” said Dr. Gary Schoolnik, Chief Medical Officer at Visby Medical and Professor of Medicine at Stanford University specializing in infectious diseases. “Visby has miniaturized this process and introduced it as a rapid PCR diagnostic for COVID-19.”
Headquartered in San Jose, California, Visby Medical was founded in 2012 by Dr. Adam de la Zerda, CEO, with Gregory Loney, COO joining shortly thereafter as a founding executive. The company spent many years developing single-use, Personal PCR to rapidly test for serious infection and was recently granted $19 million for winning the AMR Diagnostic Challenge funded by the National Institute of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA). The company’s advisory includes luminaries such as John Doerr, Chairman of Kleiner Perkins; Steven Chu, Ph.D., former Secretary of Energy and Nobel Laureate in Physics; and Peter Löscher, former President of Merck and former CEO of Siemens. The Visby Medical scientific advisory board meets regularly and is chaired by Dr. Richard Whitley.
About Visby Medical
Visby Medical has developed single-use Personal PCR to rapidly test for serious infection. Tested, reviewed, and endorsed by top public and private organizations, the first commercial application of the Visby Medical technology will be deployed in the fight against COVID-19. Visby is ready to ramp production and is gaining government and private partnerships to accelerate the delivery of mass test results to society. Going-to-market with a new diagnostic is a collaborative process, and Visby is working with key private and public leaders to help ensure society is best served by COVID-19 test results.
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.