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The pilot program will allow passengers leaving from San Francisco to take Abbott's rapid test at the airport or a mail-in test from Color before their flight.
One of the revisions specifies that the ID Now test is for use with specimens collected within the first week of symptom onset.
News items for in vitro diagnostics industry for the week of Sept. 14, 2020.
The proposed order is intended to give patients more timely access to the tests by moving them from Class III to Class II and providing special controls.
Federal mandates requiring frequent SARS-CoV-2 testing for nursing home employees and significant purchases of rapid antigen tests from HHS have raised concerns about capacity.
The new report said that point-of-care testing could rise to 70 million tests per month, or more, by October based on manufacturers' announced market entry plans.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
Some lab experts say that Abbott's test is open to multiple variables, which could lead to improper use and incorrect test results.
The FDA does not allow labs to report hs-troponin results below assays' limits of quantitation, which some argue leaves actionable information on the table.
While the market ditched shares of many other diagnostics firms, analysts said the reaction was overblown, particularly in the case of Quidel and molecular diagnostics players.