A few firms have made de novo or 510(k) submissions, but many are waiting as they continue to assess the market for their tests and look to the FDA for further guidance.
Is Abbott Antigen Test Answer to US COVID-19 Testing Problems? Stakeholders Emphasize Caution
Some lab experts say that Abbott's test is open to multiple variables, which could lead to improper use and incorrect test results.
ACLA, AdvaMed, Other Stakeholders Request Additional Funding for COVID-19 Testing From Congress
The letter calls for expanded access to COVID-testing for everyone regardless of insurance coverage or reason for receiving the test.
While industry organizations remain optimistic the bill will pass, others note challenges, including a lack of strong Congressional support and political gridlock.
Point-of-Care Testing Hit Hard by PAMA Cuts
According to industry groups, some vendors are reporting providers have returned POC testing systems because the economics of using them no longer makes sense.