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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.
News items for the in vitro diagnostics industry for the week of May 18, 2020.
Only 2.5 percent of Americans have been tested for COVID-19, even as industry scrambles to increase testing capacity and a second wave of cases may hit in the fall.
The firm anticipates using the proceeds for working capital and general corporate purposes, and to pay the net cost of convertible-note hedge transactions.
The firm's first quarter molecular diagnostics revenues were up 28 percent over Q1 2019 to $45.2 million.
Seegene said Monday that the Health Canada approval will enable hospitals and licensed labs there to run the assay immediately for high-volume testing.
Luminex said that its Q1 molecular diagnostics revenues are anticipated to rise more than 25 percent year over year, driven by SARS-CoV-2 test sales.
Luminex said that with two FDA EUAs it is now providing SARS-CoV-2 diagnostic tests for high-complexity, high-throughput labs and moderate-complexity testing facilities.