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News items for in vitro diagnostics industry for the week of Sept. 14, 2020.
Healthcare providers need multiplexed tests that can differentiate the flu from the coronavirus so they can treat patients quickly and appropriately.
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 company said that in response to the letter, it is recalling all non-Luminex temperature verification fixtures from the field for its Verigene SP instrument.
The firm delivered record revenue and the most profitable quarter in its history as a result of the increased demand for its products.
The FDA granted Luminex EUA for a multiplexed microsphere assay that measures the presence of IgG antibodies against SARS-CoV-2.
The company said that it expects to post molecular diagnostics revenues of about $65 million, up more than 100 percent compared to Q2 2019.
The firm said in an SEC document that it received an FDA warning letter in connection with the agency's requirements for its Verigene SP instrument.
A research team said the study provides some evidence that there is potential for saliva testing in broad surveillance of past exposure to SARS-CoV-2.
Of the 28 companies in the index, 21 firms saw their stock prices increase, while seven firms' share price decreased.