10/06/2020

Personal PCR: Rapid, Reliable, and Prolific

Personal PCR could one day become as common as the common cold. In the future, the device will deliver lab accurate results anywhere and to anyone — forever changing our relationship with diagnostics.

Visby Medical developed Personal PCR to, in the future, give anyone — from physicians to everyday citizens — easy access to rapid and reliable test results for serious infection. Personal PCR is single-use, palm-sized, user-friendly, and can deliver lab-accurate COVID-19 results within 30 minutes, and in the future will do the same for any serious infection, such as staph, strep and cholera. The device, which could one day be used anywhere, anytime, is currently authorized for emergency use in labs dedicated to fighting COVID-19.

In eliminating the long lead time to results, the Visby test could vastly expand the possible use cases for PCR testing. The need for such accessibility has been abundantly clear from the earliest days of the pandemic, especially in light of the delay-causing limitations inherent in lab-bound PCR, which is the current gold standard of infectious disease testing.

It is exactly the precision of that gold-standard testing that lies at the heart of why physicians and the COVID-19 data community trust PCR results almost exclusively. There simply isn’t another test as sensitive or accurate. Were PCR to be brought out of centralized labs, we could leapfrog many of the problems currently cluttering our diagnostic tool belt, not only in testing for COVID-19 today, but also in preparing for a post-pandemic world tomorrow.

 

Bring society back online

Personal PCR could offer the reliable, rapid testing required to get society back up to speed. Our nation — and the world at large — needs to reopen, but any gathering increases infection risk. This conundrum has resulted in a dangerous vacillation between outbreak and lockdown. Improper reopening results in renewed outbreak. The need to restart the economy vies with the need to tamp down infection, resulting in unclear and disparate policies and no long-term, sustainable plan.

 

CV-free zones

To begin with, widely accessible, easy-to-use PCR could make the maintenance of coronavirus-free zones — “CV-Free” zones or “bubbles,” as in the case of the NBA’s Walt Disney World Resort facility in Orlando — far simpler and more reliable. A CV-free zone is a place you can reasonably trust to be safe from COVID-19, thereby enabling gathering without fear of infection spread. However, in order to be confident that any assembly of people — a hospital or nursing home, a baseball game, your flight to London — is safe, you must be able to test each and every individual (on the spot or within a reasonable period of time in advance of entry) to be assured of reliable results. While no one can ever guarantee a 100% virus free zone, in the future, with Personal PCR we could expect to come as close as current scientific limits permit. Even more, we could catch, trace, and contain outbreaks as they occur within any individual zone. This rapid detection capability could make limiting the spread within these zones near final.

CV-free zones are just one aspect of our breakthrough device. The military will also benefit from rapid, gold-standard results while deployed to space- and resource-constrained environments, thus enhancing national security and military readiness. Lastly, outbreaks in areas with limited lab capabilities will be far easier to trace and contain.

 

The security of knowing 

Visby’s Personal PCR offers yet another groundbreaking shift for the medical community. In order to limit the risk of losing patients to follow-up care, doctors often feel forced to recommend treatment before receiving confirmation of an infection, inadvertently exacerbating the issue of antimicrobial resistance. With rapid tests available within the time frame of a patient’s visit, physicians will have access to  a lab-accurate result in a short time-frame to provide treatment with confidence.

Visby Medical’s ultimate goal is to take the accuracy and sensitivity of in-lab PCR, and put it in the hands of the layperson. The idea is that someday, within 30 minutes, anyone — anywhere, anytime — will be able to read a reliable result for whatever serious infection poses a concern — everything from an STI to COVID-19. Seven years, nine foundational patents, scientific imagination, and  rigorous clinical trials required by regulating authorities and practicing physicians have prepared Visby to enter the frontline fight against COVID-19 under EUA for operation in moderate-complexity lab environments.  The company plans to continue filing to expand the authorized use cases for Personal PCR.

 

Preparing for the next pandemic

Our most immediate need for Personal PCR today is to help halt the community spread of the coronavirus. Once beyond this trying test of the human spirit, however, Visby hopes to make tests for serious infection as prolific as the infections themselves. What Personal PCR may one day do on a societal level — on a global level — is even more groundbreaking. Personal PCR has the potential to change the way we respond to the next pandemic.

And make no mistake: there will be another pandemic. “We don’t know when or where, but we know with 100% certainty that another deadly infection will strike,” David Blumenthal and Elizabeth J. Fowler, Commonwealth Fund president and executive vice president, respectively, wrote in Harvard Business Review. “While the clear priority right now must be coping with the surging number of cases and the economic havoc that the current pandemic is wreaking, it is also time…to begin taking steps to minimize the pain of the next pandemic.”

Visby is taking those steps now.

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09/16/2020

PRESS RELEASE: Visby Medical’s Personal PCR Device Receives FDA Emergency Use Authorization for Moderate-Complexity Lab Environments

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09/16/2020

Visby exits stealth to bring its Personal PCR Test to the fight against COVID-19

Now that Visby has received EUA for our Personal PCR Test to be deployed in moderate-complexity CLIA-certified labs, we’re taking it to the front line of the fight against COVID-19. Each device is personal to individual patients, with results delivered to a lab technician in less than 30 minutes.

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