This company plans to offer home test for COVID-19

A close up shot of Coronavirus 2019-nCoV an infectious flu virus which causes respiratory illness. Human blood samples in a medical lab. 3d illustration concept

"We applaud the FDA's decision to recognize the dire need for increased access to high-quality COVID-19 tests, and to adapt as the situation demands in light of a public health emergency", Egan added.

"Over the last weeks, our emergency response teams have been working hard to bring this test to the patients".

However, authorities are moving quickly to close that gap and ramp up testing capacity.

According to npr.org, the initial test approved by the FDA is complex and requires specialized training and equipment.

It is the third EUA granted by the USA regulator during the current outbreak of the COVID-19 virus. The company sells dozens of lab tests to consumers to allow them to check cholesterol levels, fertility, and infectious diseases, including STDs. We have been engaging with test developers and encouraging them to come to the FDA and work with us. The Guidance contains policies regarding (i) laboratories' development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers' development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA.

With respect to allowing states to regulate diagnostics, Hahn said that the policy would only extend to those states that wish to take on oversight themselves, like NY. Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week.

In a statement, the FDA said the kits on the list have complied with the requirements as per FDA Memorandum No. 2020-006 entitled, "Issuance of Special Certification for Imported Test Kits of COVID-19". Abbott said it plans to distribute around 150,000 tests to customers in the United States immediately.

There are many more tests now in development, including a new point-of-care test from California-based Fluxergy that may deliver results within 60 minutes and two tests from PathogenDx-one is a respiratory test that detects influenza A and B as well as COVID-19 and COVID mutations and the other focuses on air and surface environmental transmission, the company said in an email.

The new changes demonstrate the extent to which the FDA is willing to sweep away barriers to getting more tests into the field, while still maintaining some of its oversight responsibilities.

In a third change, the FDA provided guidance to developers of serological tests, which test the blood for signs of coronavirus infection.

Related:

Comments


Other news