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. Customers will be able to order the kits from the company's website. "Leaders including President Trump and Health and Human Services Secretary Alex Azar early in the outbreak appeared unable or unwilling to envision a crisis of the scale that has now emerged, and no one stepped up to effectively coordinate among federal agencies or the private-sector labs, medical providers, and manufacturers needed for a large-scale testing push, they say".
As of early March 19, seven commercial developers and two non-commercial developers had received EUA authorization for certified clinical labs to use their tests. He said more than 80 developers have reached out to the agency for assistance with the development and validation of their products. On Feb. 26, the CDC told state and local officials via email that its "testing capacity is more than adequate to meet current testing demands", the Journal reports.More news: Cheating husband catches coronavirus after secretly taking mistress to Italy
"The policy is meant to achieve a balance between providing regulatory flexibility while allowing for critical scientific rigor", said FDA Commissioner Dr. Stephen Hahn. The FDA is requiring that it be notified within 15 business days that such use is occurring, and that labs and vendors be transparent in how they validate the tests. "At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests". Our cost-effective Logix Smart CODIV-19 test has been created to run on a variety of commercially available platforms, with easy-to-interpret results in under two hours.
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.More news: At least 13 USA journalists facing expulsion from China
The list consists of four certified test kits, two of which were manufactured in China, while the other two in South Korea. However, it should be noted that the manufacturer may have to suspend distribution and recall its products if, upon review of the EUA request, FDA identifies a significant problem that can not be addressed in a timely manner. But the agency said it has changed its approach based on the evolving nature of the coronavirus pandemic and in an effort to make more tests available.More news: Tucker Carlson Says Burr Must Resign Or Explain Stock Dump