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Cepheid

The company said it expects revenue growth to be approximately 57 percent year over year and non-GAAP core revenue growth to be approximately 29 percent.

The FDA identified molecular tests from Mesa Biotech, Applied DNA Sciences, Thermo Fisher Scientific, and Cepheid that could be affected by certain mutations.

Linear Diagnostics, which recently raised £800,000, is also seeking partners to help it market its test platform worldwide. 

The findings stem from a recent meeting of a WHO Guideline Development Group convened to address challenges with TB diagnosis and related drug-resistance.

The company's life sciences revenues grew 76 percent, while diagnostics revenues increased 24 percent.

Exact Sciences discussed newly released data and its plans for Cologuard, while Luminex provided details about its warning letter from the FDA.

The SARS-CoV-2 test, which runs on Cepheid's GeneXpert systems, is to detect SARS-CoV-2 nucleic acid in upper respiratory specimens such as nasal swabs.

The FDA last week also reissued an EUA for a PCR-based SARS-CoV-2 test from Quest Diagnostics to permit its use with pooled samples.

Cepheid said that the 4-in-1 test runs on any of almost 30,000 GeneXpert Systems, which provide results in approximately 36 minutes.

The firm's new application of its BCR-ABL test will be able to detect p190 transcripts and is currently for research use only.

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