A revolutionary new device, that can also be deemed as the ‘need-of-the-hour’, Visby’s Medical Portable Covid-19 Test kit has been authorized by the Food and Drug Administration.
The Californian medical equipment startup Visby has come up with a game-changing new device that has been granted an emergency use authorization, making it the first company to receive such authorization for a portable PCR testing kit. According to reports by the FDA, the kit rapidly replicates DNA or RNA, which is considered an accurate tool for diagnosing infectious diseases.
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
According to the Package Insert that has been approved by the FDA, The Visby COVID-19 Test is a single-use (disposable), fully-integrated, rapid, automated RT-PCR in vitro diagnostic test intended for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal, nasal, or mid-turbinate swabs collected by a health care provider (HCP), or nasal or mid- turbinate swabs self-collected (in a healthcare setting) from individuals who are suspected of COVID-19 by their healthcare provider.
The document also specifies that positive results do not rule out a bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Similarly, negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
A test that usually takes around 2 to 48 hours before reaching conclusive results, the Visby device will successfully produce the nasal swab test result in about 30 minutes. The kits are currently being assembled in San Jose, where the company is keen on manufacturing around 50,000 sets a month. The company added it wants to eventually produce an affordable test version for home use.
Seeing this approval as a major win for the start-up, CEO Adam da la Zerda said, “For people who are developing medical devices, this is the pinnacle of excitement. This is where we feel like the things we worked on can actually start doing good in the world, can actually help people.”