Home diagnostics startup Everlywell is launching an at-home coronavirus test sample kit

Co-Diagnostics Sees 'Aggressive Expansion' In Coronavirus Test Distribution After FDA Policy Revision

Coronavirus home tests could also help relieve the burden placed on hospitals amid the coronavirus pandemic, as many health centers have been overwhelmed by the rapidly-increasing COVID-19 cases, the doctors wrote.

"Over the last weeks, our emergency response teams have been working hard to bring this test to the patients". However, if FDA, upon review of the EUA request, identifies a significant problem that can not be addressed in a timely manner, the laboratory may have to stop using the test and issue test reports indicating that prior tests may be unreliable.

Co-Diagnostics Inc (NASDAQ:CODX) said Tuesday that a new US Food and Drug Administration (FDA) policy aimed at expediting the availability of coronavirus (COVID-19) test kits will allow the company to "aggressively expand" its presence in the US market. As the COVID-19 situation is changing day by day, the FDA is asking that labs with questions about the EUA process, getting key supplies, or FDA policies call their toll-free line, 1-888-INFO-FDA. We have been engaging with test developers and encouraging them to come to the FDA and work with us.

The company had earlier made its COVID-19 detection kits available to a batch of certified labs following a change in the FDA's policy on February 29, allowing labs that met a set of standards known as the Clinical Laboratory Improvement Amendments (CLIA), to use coronavirus detection tests that have been developed and validated before the FDA had reviewed their Emergency Use Authorization (EUA) submission.


"We are taking steps to support diagnostic development considering the urgent need", Hahn said in a statement. Thermo Fisher Scientific and Roche Molecular Diagnostics were the first commercial developers to receive the go-ahead late last week.

According to DFA, these kits are compliant with the requirements for the 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.

He also said that these test kits were polymerase chain reaction-based reagent kits used in laboratories and not point-of-care or do-it-yourself kits. Though manufacturers now have the go-ahead to develop serological tests, which measure the amount of proteins or antibodies responding to infection in a patient's blood, it's unclear how many developers will choose to do so. Second, where validation is required, FDA recommends the minimum testing described in section V of the Guidance. In their March 16 statement, the FDA admitted these tests "are less complex than molecular tests and are exclusively used to identify antibodies, which limits their effectiveness for diagnosis".

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