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New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 18 Sep 2020
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Image: New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization (Photo courtesy of Visby Medical)
Image: New Portable PCR COVID-19 Test Kit from Visby Medical Secures FDA Emergency Use Authorization (Photo courtesy of Visby Medical)
A new portable PCR COVID-19 test kit has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for use in lab environments.

Visby Medical (San Jose, CA, USA), a Silicon Valley startup, has become the first company to be granted FDA EUA for a portable PCR COVID-19 test kit, which it has named Personal PCR. Since the last seven years, Adam de la Zerda, the founder and CEO of Visby, has been working on shrinking the traditional PCR testing machine which is the size of a large microwave to a portable size that would fit in the palm. By bringing the power of the lab in the palm of the hand, the portable Personal PCR has the potential to be used by anyone, anywhere.

A sample taken via a nasal swab is inserted into the kit which features LED lights that indicate the test is running and alerts when it is completed. Visby’s portable Personal PCR test goes anywhere to deliver the serious infection result needed in less than 30 minutes. The single-use test with less than two minutes of hands-on time is easy to use, and delivers fast and accurate result right at the point of need. Visby’s Personal PCR is currently limited to lab use, although the company’s ultimate goal is to make the test available over the counter to anyone, anywhere at an affordable price.

“With our device you get the results you need while you’re still face to face with the patient, helping you make better and more timely decisions,” said Dr. Gary Schoolnik, Chief Medical Officer, Visby Medical.

“PCR, when appropriately applied, generates a highly sensitive and precise result. Visby’s PCR technology is so sensitive that it will pick up a signal that is likely to otherwise be missed,” said Dr. Shlomo Melmed, Executive Vice President of Academic Affairs, and Dean of the Medical Faculty and Professor of Medicine, Cedars-Sinai. “They have miniaturized PCR, validating it in the most rigorous fashion that satisfies both the compliance agencies as well as practicing physicians. This is a very important patient-friendly advance which will lead to a new class of point of care diagnostics.”

“The COVID-19 pandemic has highlighted the vital importance of very accurate, quick-response, single-use tests. With them, lives can return to normal both in developed and developing countries without causing numerous casualties,” said Sir Ronald Cohen, preeminent international philanthropist, venture capitalist, private equity investor and social innovator. “Visby’s team has shown how brilliant entrepreneurship can bring groundbreaking innovation in testing, not just for COVID-19, but for all infectious diseases, now and in the future.”

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Visby Medical


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