Recently, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a hand-held portable PCR for detection of COVID-19. The California based company Visby Medical’s single-use personal portable PCR (polymerase chain reaction) device became the first such test to be used for Covid-19 testing.
Currently, the PCR technique that amplifies and identifies DNA or RNA of the organism is the sure shot way of identifying Covid-19 pathogen. However, RT-PCR tests are not easy. They need a huge one time investment for a machine. This is followed by a continuous quest for reagents and chemicals which are also expensive.
A simple test with less equipment and quick, accurate results is the need of the hour. Visby Medical’s test for COVID-19 is the first PCR-based, single-use test. “We are humbled by the FDA’s decision,” said Dr Adam de la Zerda, Founder , 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,” he added.
Personal PCR test is supposed to be simple to operate. It is a palm-sized device which can read the sample, do control sample test, and give results within 30 min. To begin, the sample is placed in a sample well and closed. At the press of the button a LED status lights indicate the test is running and provide an alert when the test finishes. With two-min of human intervention and 30-min of run time the device validates the test and gives a yes/no answer for infection.
Expanding the Horizon
If this technology is used on a large scale it could possibly expand the use case for PCR based testing. The test promises to eliminate the long lead time to results and integrate the entire PCR process into one machine. In a country like India, a portable PCR device could add to the efforts of the government to make early diagnostics accessible and available for all, because simpler solutions which are cost sensitive find larger adoption in resource poor settings.
However, the size may not matter if the accuracy and specificity, two parameters to grade any new diagnostic test is not accepted by the clinicians.
“Healthcare and medical professionals trust the PCR technique for its reliability and high accuracy,” says Dr Gary Schoolnik, Chief Medical Officer at Visby Medical and Professor of Medicine at Stanford University specialising 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. 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.
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.