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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.
Under a proposed rule, devices given FDA's breakthrough designation would, upon receiving FDA market authorization, immediately be covered by Medicare.
The test is a version of Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit that has been modified for use with a different PCR instrument and plate format.
In clinical samples, the researchers detected more viral copies in saliva than in NP swabs, and more saliva samples remained positive for up to 10 days.
The international competition's goal is to spark innovation and accelerate safe returns to work, school, and other public activities.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
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.
The New York startup is curating available data for all Emergency Use Authorized molecular diagnostic tests for the benefit of the public.
The agency approved the test for use across solid tumors and with multiple companion diagnostic indications including one for prostate cancer and three for lung cancer.