Luminex

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.

The GenomeWeb Index rose more than 9 percent in May, following an 18 percent climb in April, a marked contrast to its negative performance in February and March.

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.

The Aries SARS-CoV-2 assay provides results in approximately two hours and can be run on Luminex's sample-to-answer Aries Systems.

The NxTag CoV Extended Panel is a multiplex PCR test that uses the company's bead-based NxTag technology to detect coronavirus in nasopharyngeal swab specimens.

The company said it expects to launch the Verigene II system with respiratory and gastrointestinal assays in the middle of this year.