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In Brief This Week: Thermo Fisher Scientific, FDA, Fulgent Genetics, OpGen, More

NEW YORK – OpGen said this week that its preliminary revenues for the second quarter of 2022 were approximately $1.0 million, up from $800,000 in Q2 of 2021. Last month, the infectious disease diagnostics company signed its first commercial contract for its Acuitas AMR Gene Panel in the US with a major hospital in the Northeast. In addition, it expanded its distribution agreement with Menarini, which committed to higher annual minimum revenues and purchased the entire pool of installed Unyvero systems in nine European countries at residual fair market value from OpGen subsidiary Curetis. As of June 30, OpGen had about $16.6 million in cash. 

Thermo Fisher Scientific said this week that its board of directors on July 7 authorized a quarterly cash dividend of $.30 per common share, payable on Oct. 14 to shareholders of record as of Sept. 15. 

Helio Genomics and Fulgent Genetics said this week that the American Medical Association has issued a new Category I Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code for the HelioLiver assay for hepatocellular carcinoma. The code will become effective on Oct. 1, 2022. 

The US Food and Drug Administration said this week that InBios International's SCoV-2 Ag Detect Rapid Self-Tests and SD Biosensor's Pilot COVID-19 At-Home Tests that received Emergency Use Authorization from the agency have a longer shelf life than previously authorized. The FDA has extended the expiration dates for the tests as a result. The extension is based on additional data that was provided by the manufacturers demonstrating how long the tests can be used with the same accuracy. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.