Visby Medical Inc. emerged from stealth mode to secure emergency use authorization (EUA) from the U.S. FDA for its Personal PCR device for detection of COVID-19 infections. It is the first FDA-authorized portable device to use the polymerase chain reaction technology for COVID-19 testing.

The San Jose, Calif.-based company was known as Click Diagnostics Inc. until March 2020.

The pregnancy test-like disposable device produces a single dot indicating a valid outcome and a second dot appears if the result is positive. It takes 30 minutes to process samples from swabs collected by health care workers or patients under supervision of health care workers.

“Visby's Personal PCR could make an impact in high-density areas for high- and low-throughput facilities,” Ryan Schmidt, Visby’s vice president of marketing, told BioWorld. “Clinicians could use it whenever needed and have a store of devices on hand as necessary. We plan to sell the devices in packs to ensure facilities have enough of the devices to meet demand.”

Personal PCR is currently approved for use in moderate complexity lab environments, expanding testing availability for frontline health care workers, at-risk employees, pre-surgical patients, and symptomatic patients. The quick results from the device overcomes some of the most significant challenges to controlling spread of the SARS-CoV-2 virus, enabling accurate, rapid testing for high-risk individuals and obtaining results quickly enough to make contact tracing worthwhile.

“Molecular PCR technology is considered the gold standard technology for testing for infections due to its high level of sensitivity,” Schmidt noted. “The advantage of PCR is increased sensitivity versus antigen tests. In fact, many antigen tests recommend that you confirm the negative results with a molecular PCR test.”

"The COVID-19 crisis has shown that we don't just need more testing; what we really need are accurate results delivered quickly,” said Visby Founder and CEO Adam de la Zerda. “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."

The technology

To run a test, a user inserts a sample swab into the hand-held test kit and slides the first button closed. Pressing down the second and third buttons starts the test. LED status lights indicate the test is running and provide an alert when the test finishes. No equipment is required beyond the device itself. The testing takes two minutes of hands-on time.

“Typically, the availability of instruments dictates the number of tests that can be run in a certain period of time,” said Schmidt. By consolidating the entire polymerase chain reaction process into one device with an integrated cartridge and instrument, “we have removed the dependence on instruments and created a testing paradigm where many COVID-19 tests can be run in parallel.”

Currently, Visby’s authorization limits use of the device to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The company hopes to bring Personal PCR out of the lab and into the point-of-care setting and directly to individuals to permit on-demand testing by anyone, anywhere.

Pricing of the device has not been set. “However, we are committed to making the product pricing affordable and value-based,” Schmidt said.

Visby has already begun distribution of Personal PCR and is currently producing tens of thousands of devices per week. The company is expecting to ramp up production in the near term and is establishing both public and private partnerships to accelerate its ability to deliver enough devices to meet mass testing needs.

The Personal PCR recently received $19 million as the winner of the AMR Diagnostic Challenge funded by the National Institute of Health and the Biomedical Advanced Research and Development Authority.

The company is currently developing a recycling program for its devices, as the majority of the components can be reused.

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