COVID-19 LAB TESTS RECEIVING FDA EMERGENCY USE AUTHORIZATION ((s) = Serology Test (a) = Antigen Test (t) = Total Antibody Test) Date Manufacturer(s) Test Receiving EUA July … [Read more...]
FDA Watch
First Warning Letters Issued for Improper Marketing of SARS-CoV-2 Antibody Tests
July 14, 2020
No more Mr. Nice Guy. For the first time, the FDA has exercised its enforcement powers to crack down on makers of unproven serologic SARS-CoV-2 antibody tests. A 180⁰ Pivot When the public … [Read more...]
Emerging Tests
Employers Show Signs of Hesitation on COVID-19 Return to Work Testing
July 14, 2020
Business reopening and return to work was expected to create a massive new market for employer point-of-care COVID-19 workplace screening tests. However, there are troubling new indications that … [Read more...]
Tool
Model COVID-19 Contact Log Sheet
July 6, 2020
Maintaining social distancing will be the price that labs and other businesses will have to pay to reopen and remain open until the COVID-19 threat goes away. But for social distancing to work, there … [Read more...]
GAO Report
Federal COVID-19 Testing Data Collection Effort Has Been Ineffective
July 3, 2020
The federal government has done a poor job of collecting and reporting COVID-19 testing data to the CDC since the pandemic began. That’s the conclusion of a U.S. Government and Accountability Office … [Read more...]
FDA Watch
First Enforcement Action for Improper Marketing of SARS-CoV-2 Antibody Tests
June 25, 2020
After initially allowing producers of serologic SARS-CoV-2 antibodies tests free access to the market, the US Food and Drug Administration (FDA) is now cracking down on unproven and inaccurate … [Read more...]
