FDA Approves OTC Coronavirus Home-Sample Collection Kit

December 21, 2020 14:20:38

Last week, the Food and Drug Administration (FDA) announced that it had approved the first over-the-counter (OTC) home-sample collection kit for the coronavirus. The coronavirus test collection kit — LabCorp Pixel kit — is permitted for use by people aged 18 years and above and can be used without a prescription. The testing kit includes a nasal swab, which will be used to collect a sample at home. The self-collected sample can then be sent out to be tested at LabCorp.

Test users will then receive their test results either through an online portal, a phone call from their health-care provider or email. If test results are negative, they will be delivered through the user online portal or via email. However, if an individual’s test results are invalid or positive, the results will be delivered to the individual via a phone call from a health=care provider.

Using this home-sample collection kit eliminates the need to leave your house to get tested, which exposes an individual to various risk factors. The FDA states that the home-collection kit allows its users to learn more about their coronavirus infection status, which could help in determining whether quarantining oneself would be an appropriate measure. The kit would also assist an individual’s health-care professional to make the appropriate decision concerning their patient or give proper advice on measures to be taken.

In another news release by the FDA, Jeff Shuren, the director of the Center for Devices and Radiological Health, explained that currently several home-collection kits are available for prescription using an online questionnaire. However, the newly approved home-sample collection kit makes it easier for individuals to obtain samples and send those samples to a lab for processing, without having to fill out a questionnaire and await a prescription.

Earlier this month, the FDA also reported that an at-home diagnostic test that could be used to collect samples of influenza B and A as well as the coronavirus had been approved. The Quest Diagnostics Self-Collection Kit for the flu and coronavirus and the Quest Diagnostics Flu and coronavirus reverse transcription PCR test can be used by individuals who suspect that they may have a respiratory viral infection with the coronavirus; both are available to the public and can be obtained using a prescription.

Aside from COVID-19, many biopharm companies are working to develop remedies for various ailments afflicting people. An example is Processa Pharmaceuticals Inc. (NASDAQ: PCSA), a company that focuses on acquiring drugs still in the development stage but with reasonable evidence of efficacy.

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