UPDATED 3:05 PM PT – Thursday, September 17, 2020
The Food and Drug Administration has authorized a portable COVID test from a California medical equipment startup. According to reports, Visby Medical’s test was granted emergency use authorization, making it the first company to receive such authorization for a portable PCR testing kit.
We’re excited to announce that Visby Medical has received FDA Emergency Use Authorization! We’re grateful for the opportunity to share our story with @Reuters in preparation of this news. To read the exclusive story, visit:https://t.co/yWRBq3NEbD#VisbyMedical #personalPCR
— Visby Medical, Inc. (@visbymedical) September 17, 2020
The FDA has said the kit rapidly replicates DNA or RNA, which is considered an accurate tool for diagnosing infectious diseases.
The nasal swab test will reportedly produce a result in about 30 minutes.
“For people who are developing medical devices, this is the pinnacle of excitement,” stated Visby Medical CEO Adam da la Zerda. “This is where we feel like the things we worked on can actually start doing good in the world, can actually help people.”
The kits are being assembled in San Jose, where the company can reportedly manufacture around 50,000 a month. The company added it wants to eventually produce an affordable test version for home use.